FDA1084029_PricingMatrix1.xls
XLS spreadsheet 103 KB Posted
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- Management and Coordination of the Maintenance and Repair Services for Scientific Instruments
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- FDA1084029
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Pricing Matrix Master Instrument List for FDA1094029. Please note that no password is required just select read-only .
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Acronyms
| CFSAN branch names | |
| SMSB | Spectroscopy and Mass Spectrometry Branch |
| BMB | Bioanalytical Methods Branch |
| CHCB | Chemical Contaminants Branch |
| MDB | Method Development Branch |
| DM/MMSB | Div. Microbiology / Molecular Methods and Sub-typing |
| MFCNB | Moffet Food Chemistry and Nutrition Branch |
| DFS | Division of Field Science |
| CVM Division Names | |
| DRC | Division of Residue Chemistry |
| DAVR | Division of Applied Veterinary Research |
| VET-LRN | Veterinary Laboratory Response Network |
| OFS | Office of Food Science |
| ORS | Office of Regulatory Science |
| ORS | Office of Research |
| OTR | Office of Testing and Research |
| ORO | Office of Regional Operations |
| ESR | electron spin resonance |
| SPR | surface plasmon resonance |
| AES | atomic emission spectrometer |
| XRF | X-ray fluorometer |
| MS | mass spectrometer |
| ICP | inductively-coupled plasma |
| FT-IR | Fourier-transform infrared |
cost estimation
| count | # PMs requested for instruments to be covered initially | $ per PM | Totals | |
| Grand Total | 174 | 79 | $2,424 | $191,500 |
| MS | 71 | 64 | $2,500 | $160,000 |
| GC-MS | 7 | 0 | $2,000 | $0 |
| LC-MS | 1 | 2 | $2,500 | $5,000 |
| ICP-MS | 2 | 0 | $1,500 | $0 |
| LC-MS | 34 | 5 | $1,500 | $7,500 |
| UPLC | 39 | 1 | $2,000 | $2,000 |
| Autosampler | 3 | 0 | ||
| Bacterial Growth Measurement | 1 | 1 | $2,500 | $2,500 |
| Bacterial Identification | 3 | 1 | $2,000 | $2,000 |
| Bioanalyzer | 1 | 0 | ||
| BioPlex | 7 | 2 | $2,500 | $5,000 |
| Centrifuge | 1 | 0 | ||
| Column Chiller | 1 | 0 | ||
| Confocal Microscope | 2 | 2 | $2,500 | $5,000 |
| Digital PCR | 1 | 1 | $2,500 | $2,500 |
mass spectrometer systems
| INDEX | LOCATION INFORMATION | INSTRUMENT INFORMATION | DATES | SERVICING REQUIREMENTS | PRICING INFORMATION TO BE COMPLETED BY VENDOR | |||||||||||||||||||||
| Program Sort Index | Instrument Number (barcode preferred, or local identifier) | Center | City, State, Zip of physical location | Type of instrument (generic) | Manufacturer | Model | Serial Number | Associated instrument controlled by MS data system (eg, GC, LC,…) | Associated HPLC/UPLC make and model | Associated HPLC/UPLC Serial number | Data system and version | Current firmware version (if applicable) | Does instrument have internet access? | FDA Installation Date | If under warranty, give expiration date | If under service contract, give contract expiration date | Add to Master Equipment List? (i.e, cover now or add later?) | Is OEM the only acceptable servicing sub-contractor? | How many maintenance visits to be scheduled per year? 0, 1, 2, more? | Service level;: 1, 2, or 3 | Acceptance Standard | Documentation Required | How many repair on-site service call per year per instrument? (estimated average, based on recent experience) | Cost for Preventive Maintenance visits (see column T and U) per year per instrument | Cost for On-site Repair Call Service (see column X) per year per instrument | Cost of full service contract or estimate thereof, based on requirements provided |
| 1 | 1017727 | CFSAN | Bedford Park, IL 60501 | LC-MS | Waters | TQD | QBB1113 | MassLynx 4.1 | No | 11/23/11 | 11/22/12 | No | Yes | 1 | 1 | OEM Spec | Signature | 0.5 | ||||||||
| 2 | 1017727 | CFSAN | Bedford Park, IL 60501 | UPLC | Waters | ACQUITY | H10VPB007A | MassLynx 4.1 | No | 11/23/11 | 11/22/12 | No | Yes | 1 | 1 | OEM Spec | Signature | 1.0 | ||||||||
| 3 | 1017727 | CFSAN | Bedford Park, IL 60501 | UPLC | Waters | ACQUITY | K10VPA074M | MassLynx 4.1 | No | 11/23/11 | 11/22/12 | No | Yes | 1 | 1 | OEM Spec | Signature | 1.0 | ||||||||
| 4 | 1017727 | CFSAN | Bedford Park, IL 60501 | UPLC | Waters | ACQUITY | H10VPL456A | MassLynx 4.1 | No | 11/23/11 | 11/22/12 | No | Yes | 1 | 1 | OEM Spec | Signature | 1.0 | ||||||||
| 5 | 1017727 | CFSAN | Bedford Park, IL 60501 | UPLC | Waters | ACQUITY | G10VPH962G | MassLynx 4.1 | No | 11/23/11 | 11/22/12 | No | Yes | 1 | 1 | OEM Spec | Signature | 1.0 | ||||||||
| 6 | A106844 | CFSAN | Bedford Park, IL 60501 | LC-MS | Waters | Micromass ZQ 2000 | LAA890 | Empower | No | unknown (old) | Yes | Yes | 0 | 3 | OEM Spec | Signature | 0.5 | |||||||||
| 7 | 1017756 | CFSAN | Bedford Park, IL 60501 | LC | Waters | 2695 Alliance | JQ2SM4256M | Empower | No | unknown (old) | Yes | Yes | 0 | 3 | OEM Spec | Signature | 1.0 | |||||||||
| 8 | 1017755 | CFSAN | Bedford Park, IL 60501 | LC | Waters | 2996 | HO2296452M | Empower | No | unknown (old) | Yes | Yes | 0 | 3 | OEM Spec | Signature | 1.0 | |||||||||
| 9 | N/A | CFSAN | Bedford Park, IL 60501 | LC | Waters | 2475 | JO2475913M | Empower | No | unknown (old) | Yes | Yes | 0 | 3 | OEM Spec | Signature | 1.0 | |||||||||
| 10 | N/A | CFSAN | Bedford Park, IL 60501 | LC | Waters | 186000267 | GO1ACH782M | Empower | No | unknown (old) | Yes | Yes | 0 | 3 | OEM Spec | Signature | 1.0 | |||||||||
| 11 | 1015151 | CFSAN | Bedford Park, IL 60501 | LC-MS | Waters | Quattro Micro | QA119 | MassLynx 4.1 | No | unknown (old) | 6/21/11 | Yes | Yes | 1 | 2 | OEM Spec | Signature | 0.5 | ||||||||
| 12 | N/A | CFSAN | Bedford Park, IL 60501 | LC | Waters | WAT270852 | JO2SMH454M | MassLynx 4.1 | No | unknown (old) | Yes | Yes | 0 | 2 | OEM Spec | Signature | 1.0 | |||||||||
| 13 | Item coming in July | CDER | Silver Spring, MD, 20993 | LC-MS | Agilent Technologies | 6500 | Unknown at this time | LC | Yes | FY2011 | Yes | Yes | 2-PM | 1 | pre-test | 3rd Party Service Report | 0.5 | |||||||||
| 14 | 5077489 | CVM | Laurel, MD 20708 | LC-MS | Applied Biosystems/MDS Sciex | API 4000 | 1034067 | Agilent 1100 LC | Analyst 1.5.1 | No | 6/25/10 | 6/25/11 | 8/16/12 | No | Yes | 2 | 1 | OEM specification | Performance Test Data | 0.5 | ||||||
| 15 | 5096137 | CVM | Laurel, MD 20708 | LC-MS | ThermoFinnigan | LCQ Deca XP Plus | LDP00418 | Waters Alliance LC | XCalibur | Yes | 6/20/03 | Yes | Yes | 0 | 2 | signature | Service Report | 0.5 | ||||||||
| 16 | 5141076 | CVM | Laurel, MD 20708 | LC-MS | Thermo Scientific | LTQ Velos | LTQ30531 | Eksigent nanoLC | Xcalibur | Yes | 1/6/2011 | 1/6/2012 | No | Yes | 2 | 1 | OEM specification | Performance Test Data | 0.5 | |||||||
| 17 | 5141097 | CVM | Laurel, MD 20708 | LC-MS | Applied Biosytems | Voyager DE-STR | 4410 | Voyager data Explorer | Yes | 9/21/07 | Yes | Yes | 0 | 3 | signature | Signature | 0.5 | |||||||||
| 18 | 5096351 | CVM | Laurel, MD 20708 | LC-MS | Micromass (Waters) | Quattro Micro | QAA539 | Waters Acquity Ultra Performance LC | G06UPB704M | MassLynx 4.1.1 | Yes | 8/27/03 | Yes | Yes | 2 | 2 | instrument SOP | Service Report | 0.5 | |||||||
| 19 | 5096444 | CVM | Laurel, MD 20708 | LC-MS | Waters | TQDetector | QBA 705 | MassLynx 4.1.1 | Yes | 9/21/09 | Yes | Yes | 2 | 2 | OEM specification | Performance Test Data | 0.5 | |||||||||
| 20 | 5077429 | CVM | Laurel, MD 20708 | UPLC | Waters | Waters Acquity Ultra Performance LC | G06UPB704M | MassLynx 4.1.1 | Yes | 9/26/06 | Yes | Yes | 0 | 2 | OEM specification | Service Report | 1.0 | |||||||||
| 21 | 5063854 | CVM | Laurel, MD 20708 | LC-MS | Agilent Technologies | Q-TOF 6530A | US84020305 | Agilent 1200 HPLC | Mass Hunter B.02.00 | Yes | 11/12/08 | Yes | Yes | 2 | 2 | OEM specification | Service Report | 0.5 | ||||||||
| 22 | 5096414 | CVM | Laurel, MD 20708 | LC-MS | Micromass (Waters) | Quattro Micro | QAA597 | LC | Waters Acquity Ultra Performance LC | G06UPB 702M (PUMP), H06UPS 835M (Sample Manager) | MassLynx 4.1.1 | Yes | 10/14/03 | Yes | Yes | 2 | 2 | instrument SOP | Service Report | 0.5 | ||||||
| 23 | 5077430 | CVM | Laurel, MD 20708 | UPLC | Waters | Waters Acquity Ultra Performance LC | G06UPB 702M (PUMP), H06UPS 835M (Sample Manager) | MassLynx 4.1.1 | Yes | 10/23/06 | Yes | Yes | 0 | 2 | OEM specification | Service Report | 1.0 | |||||||||
| 24 | 5096350 | CVM | Laurel, MD 20708 | LC-MS | ThermoFinnigan | TSQ Quantum | TQU00128 | LC | XCalibur 2.0 | Yes | 11/7/03 | Yes | Yes | 0 | 2 | signature | Signature | 0.5 | ||||||||
| 25 | 5077417 | CVM | Laurel, MD 20708 | LC-MS | ABI Sciex | 4000QTrap | U18310703 | Shimadzu LC | Analyst 1.5.1 | Yes | 6/1/07 | 4/30/12 | No | Yes | 2 | 1 | instrument SOP | Performance Test Data | 0.5 | |||||||
| 26 | 5141071 | CVM | Laurel, MD 20708 | LC-MS | Applied Biosystems | API 4000 | V26891003 | Shimadzu LC | Analyst 1.5.1 | Yes | 7/1/10 | 7/1/11 | Yes | Yes | 2 | 1 | OEM specification | Performance Test Data | 0.5 | |||||||
| 27 | 5058821 | CVM | Laurel, MD 20708 | LC-MS | AB Sciex | API 2000 | 549810 | LC | Analyst 1.5.1 | Yes | 6/20/95 | Yes | No | 0 | 3 | signature | Signature | 0.5 | ||||||||
| 28 | 5096448 | CVM | Laurel, MD 20708 | LC-MS | AB Sciex | AB Sciex 5500 | BB20110906 | LC | Analyst 1.5.1 | Yes | 9/11/09 | 9/9/2010 | 9/9/14 | No | Yes | 2 | 1 | OEM specification | Performance Test Data | 0.5 | ||||||
| 29 | 1014174 | CFSAN | College Park, MD 20740 | LC-MS | Waters | Q-TOF PREMIER | HAA090 | Waters Acquity Ultra Performance LC | F09UPB 749M (pump) | MassLynx 4.1 | Yes | 9/9/05 | Yes | Yes | 1 | 1 | OEM spec | Signature | 0.5 | |||||||
| 30 | CFSAN | College Park, MD 20740 | UPLC | Waters | Acquity | F09UPB 749M (pump) | ICOPS | No | 10/1/05 | Yes | Yes | 0 | 2 | OEM spec | Signature | 1.0 | ||||||||||
| 31 | 5107322 | CFSAN | College Park, MD 20740 | LC-MS | Thermo Fisher | LTQ XL | LTQ20487 | LC | NANO Acquity | E06NPS 172M | Excalibur | Yes | 10/1/07 | Yes | Yes | 1 | 1 | OEM spec | Signature | 0.5 | ||||||
| 32 | 1014171 | CFSAN | College Park, MD 20740 | Nano-LC | Waters | NANO Acquity | E06NPS 172M | ICOPS | 10/1/05 | Yes | Yes | 1 | 1 | OEM spec | Signature | 0.5 | ||||||||||
| 33 | 1014163 | CFSAN | College Park, MD 20740 | LC-MS | AB Sciex | 4000 QTrap | U016410605 | LC | Prominence Nano LC | L20354655396US,SS-3-0974,SSI-3-0975, L20124650198, L20104652809,L20464600071 | Analyst 1.5.1 | Yes | 11/1/06 | Yes | Yes | 1 | 1 | OEM spec | Signature | 0.5 | ||||||
| 34 | CFSAN | College Park, MD 20740 | Nano-LC | Shimadzu | Prominence Nano LC | L20354655396US,SS-3-0974,SSI-3-0975, L20124650198, L20104652809,L20464600071 | No | Yes | Yes | 0 | 2 | OEM spec | Signature | 0.5 | ||||||||||||
| 35 | 1019659 | CFSAN | College Park, MD 20740 | LC-MS | Waters | SYNAPT G2 HDS 4k | UCA169 | LC | Acquity | F09UPA308M | MassLynx 4.1 | No | 1/10/10 | 9/1/11 | Yes | Yes | 1 | 1 | OEM spec | Signature | 0.5 | |||||
| 36 | CFSAN | College Park, MD 20740 | UPLC | Waters | Acquity | F09UPA308M | ICOPS | No | 6/1/06 | Yes | Yes | 1 | 2 | OEM spec | Signature | 1.0 | ||||||||||
| 37 | 1014164 | CFSAN | College Park, MD 20740 | LC-MS | AB Sciex | ABI 4800 | AK011120606 | 4000 Series Explorer | Yes | 11/1/06 | Yes | Yes | 1 | 2 | OEM spec | Signature | 0.5 | |||||||||
| 38 | 5059800 | CFSAN | College Park, MD 20740 | LC-MS | Thermo Fisher | LTQ ORBITRAP XL | 01705B | NanoLC-Ultra 2D | 90114156 | Excalibur | Yes | 10/1/08 | 9/30/12 | No | Yes | 3 | 1 | OEM spec | Signature | 0.5 | ||||||
| 39 | 1014169 | CFSAN | College Park, MD 20740 | MS interface | Advion Biosciences | Advion Triversa Nanomate | TC235 | N/A | 11/1/06 | Yes | Yes | 1 | 1 | OEM spec | Signature | 1.0 | ||||||||||
| 40 | 5059834 | CFSAN | College Park, MD 20740 | Nano-LC | EKSIGENT | NanoLC-Ultra 2D | 90114156 | controlled by orbitrap MS | N/A | Yes | 6/1/09 | Yes | Yes | 1 | 1 | OEM spec | Signature | 0.5 | ||||||||
| 41 | CFSAN | College Park, MD 20740 | LC-MS | Bruker | IBIS T5000 | OTO201G003 | Autosampler and robots | Yes | 12/1/07 | Yes | Yes | 1 | 1 | OEM spec | Signature | 0.5 | ||||||||||
| 42 | 1019539 | CFSAN | College Park, MD 20740 | LC-MS | LECO | Pegasus 4D GCxGC TOFMS | 3335 (TOF), US10734020 (GC), 8053 (Autosampler) | Agilent 7890 GC and Gerstel MPS2+PTV | Yes | 7/22/07 | 12/1/10 | Yes | Yes | 0 | 2 | instrument SOP | signature | 0.5 | ||||||||
| 43 | 5059561 | CFSAN | College Park, MD 20740 | GC-MS | Agilent Technologies | 7890A GC/5975C MSD/7093 AS | US10940006 (GC), US92033531 (MSD) | MSD Chemstation | Yes | Yes | 0 | 2 | OEM spec | signature | 0.5 | |||||||||||
| 44 | 1014029 | CFSAN | College Park, MD 20740 | LC-MS | AB Sciex | 4000 QTrap | AR23800902 | LC | Analyst 1.5.1 | Yes | 7/1/09 | 6/30/12 | No | Yes | 1 | 1 | OEM spec | Signature | 0.5 | |||||||
| 45 | CFSAN | College Park, MD 20740 | LC-MS | AB Sciex | 5000 | AG0126900607 | LC | Analyst 1.5.1 | Yes | 10/20/06 | Yes | Yes | 1 | 1 | OEM spec | Signature | 0.5 | |||||||||
| 46 | 1019663 | CFSAN | College Park, MD 20740 | Turbulent flow LC | Thermo Fisher | TLX-2 | R2009265002 | ABI 5000 AG012690607 | Aria-OS 1.6.2 | Yes | 6/1/09 | Yes | Yes | 1 | 2 | OEM spec | Signature | 1.0 | ||||||||
| 47 | CFSAN | College Park, MD 20740 | LC | Agilent Technologies | 1100 | DE11109454 | Analyst/MassLynx/ChemStation | 10/1/04 | Yes | OEM approved | 0 | 2 | OEM spec | Signature | 1.0 | |||||||||||
| 48 | CFSAN | College Park, MD 20740 | GC-MS | Waters | GCT PREMIER | US10544023 | GC | MassLynx 4.1 | Yes | 1/10/06 | Yes | Yes | 0 | 2 | OEM spec | Signature | 0.5 | |||||||||
| 49 | CFSAN | College Park, MD 20740 | LC-MS | Waters | ZQ | LAA1744 | LC | Acquity | F05UPA309M | MassLynx 4.1 | Yes | 4/1/06 | Yes | Yes | 0 | 2 | OEM spec | Signature | 0.5 | |||||||
| 50 | 1014029 | CFSAN | College Park, MD 20740 | UPLC | Waters | Acquity | F05UPA309M | ICOPS | No | 4/1/06 | Yes | Yes | 0 | 2 | OEM spec | Signature | 1.0 | |||||||||
| 51 | 1019667 | CFSAN | College Park, MD 20740 | LC-MS | Agilent Technologies | 6538 UHD-QTOF | US94180208 | LC | 1290 INFINITY | DEBAA00723 (Pump) | Mass Hunter B.03.01 | Yes | 3/1/10 | Yes | Yes | 1 | 1 | OEM spec | Signature | 0.5 | ||||||
| 52 | 1019662 | CFSAN | College Park, MD 20740 | UPLC | Agilent Technologies | 1290 INFINITY | DEBAA00723 (Pump) | Mass Hunter B.03.01 | Yes | 10/1/10 | Yes | Yes | 0 | 2 | OEM spec | Signature | 1.0 | |||||||||
| 53 | 5059833 | CFSAN | College Park, MD 20740 | LC-MS | AB Sciex | 5500 QTrap | AU21040909 | LC | Analyst 1.5.1 | Yes | 6/1/08 | Yes | Yes | 1 | 1 | OEM spec | Signature | 0.5 | ||||||||
| 54 | 1014053 | CFSAN | College Park, MD 20740 | LC-MS | Thermo Fisher | Exactive | SN01043P | LC | Excalibur | Yes | 6/1/09 | Yes | Yes | 1 | 1 | OEM spec | Signature | 0.5 | ||||||||
| 55 | CFSAN | College Park, MD 20740 | LC-MS | AB Sciex | 4000 QTrap | AR24100904 | Infinity Bin Pump | DE92900201 | Analyst 1.5.1 | Yes | 7/1/09 | 7/1/12 | No | Yes | 1 | 1 | OEM spec | signature | 0.5 | |||||||
| 56 | CFSAN | College Park, MD 20740 | LC-MS | AB Sciex | 5500 QTrap | AU23971008 (Qtrap), L20434850276 (pump), L20434850273 (pump), L20454750096 (autosampler), L20234852715 (communication module), L20214850726 (column oven), 4723282-96 (aircompressor), LCMS-5000NA-1248A (N2 generator) | Shimadzu Prominence | L20434850276 (pump), L20434850273 (pump), L20454750096 (autosampler), L20234852715 (communication module), L20214850726 (column oven), 4723282-96 (aircompressor), LCMS-5000NA-1248A (N2 generator) | Analyst 1.5.1 | Yes | 8/15/10 | Yes | Yes | 1 | 1 | OEM spec | signature | 0.5 | ||||||||
| 57 | CFSAN | College Park, MD 20740 | GC-MS | Varian Instruments | 320-MS | MS0906W041 | Yes | 3/1/09 | Yes | Yes | 0 | 3 | per Instrument SOP | signature | 0.5 | |||||||||||
| 58 | CFSAN | College Park, MD 20740 | LC-MS | AB Sciex | API 2000 | B5060208 | Analyst 1.4.1 | Yes | 6/1/02 | No | Yes | 0 | 3 | per Instrument SOP | signature | 0.5 | ||||||||||
| 59 | CFSAN | College Park, MD 20740 | LC-MS | AB Sciex | 5500 QTrap | AU20020901 | UPLC | Infinity Bin Pump | DE92900202 | Analyst 1.5.1 | No | 7/1/09 | 6/1/12 | No | Yes | 2 | 2 | per Instrument SOP | signature | 0.5 | ||||||
| 60 | CFSAN | College Park, MD 20740 | Nitrogen Generator | Parker Hannifan/Mettler Toledo | LCMS5000NA | LCMS5000NA-1159 | 7/1/09 | Yes | Yes | 1 | 1 | OEM Spec | Signature | 0.2 | ||||||||||||
| 61 | 1014538 | CFSAN | College Park, MD 20740 | GC-MS | Agilent Technologies | 5975 | US90432051 | GC | TurboMatrix 40 Trap | EN55011 | CHEMSTATION | Yes | 7/1/09 | Yes | Yes | 0 | 2 | n/a | signature | 0.5 | ||||||
| 62 | none | CFSAN | College Park, MD 20740 | autosampler | Perkin-Elmer | TurboMatrix 40 Trap | EN55011 | No | Yes | Yes | 0 | 2 | n/a | signature | 1.0 | |||||||||||
| 63 | CFSAN | College Park, MD 20740 | LC-MS | Varian Instruments | 1200L Triple upgrade | 12233 | 1200L with Combipal | 12233 | Excalibur | Yes | 9/18/06 | Yes | Yes | 0 | 1 | OEM spec | signature | 0.5 | ||||||||
| 64 | CFSAN | College Park, MD 20740 | LC | VARIAN INSTRUMENTS | 1200L with Combipal | 12233 | 9/26/05 | Yes | Yes | 0 | 1 | OEM spec | signature | 1.0 | ||||||||||||
| 65 | CFSAN | College Park, MD 20740 | GC-MS | Agilent Technologies | 6890A/5873Network | US00041316 | ChemStation | Yes | 10/10/05 | Yes | Yes | 0 | 3 | per Instrument SOP | signature | 0.5 | ||||||||||
| 66 | none | CFSAN | College Park, MD 20740 | LC-MS | Agilent Technologies | 6410 | US73910522 | LC | MASSHUNTER B.03.01 | Yes | 6/1/08 | Yes | Yes | 0 | 2 | n/a | signature | 0.5 | ||||||||
| 67 | none | CFSAN | College Park, MD 20740 | GC-MS | Agilent Technologies | 5975 | US53941337 | GC | Gerstel MPS2 | 127289 | CHEMSTATION | Yes | 11/1/05 | Yes | Yes | 0 | 2 | n/a | signature | 0.5 | ||||||
| 68 | none | CFSAN | College Park, MD 20740 | autosampler | Gerstel | MPS2 | 127289 | CHEMSTATION | Yes | 11/2/05 | Yes | Yes | 0 | 2 | n/a | signature | 1.0 | |||||||||
| 69 | 1014515 | CFSAN | College Park, MD 20740 | LC-MS | Agilent Technologies | 1100 | US04410289 | LC | ChemStation (2006) | Yes | 5/1/01 | Yes | No | 1 | 2 | None | None | 0.5 | ||||||||
| 70 | 1015815 | CFSAN | College Park, MD 20740 | LC-MS | Agilent Technologies | 1100MSD | US24113038 | LC | CHEMSTATION | Yes | 12/13/02 | Yes | Yes | 0 | 2 | n/a | signature | 0.5 | ||||||||
| 71 | CFSAN | College Park, MD 20740 | GC-MS | Varian Instruments | 320-MS | MS0809W026 | Varian MS Workstation 6.9.2 | Yes | 3/1/09 | Yes | Yes | 2 | 1 | OEM spec | signature | 0.5 | ||||||||||
| 72 | 1014500 | CFSAN | College Park, MD 20740 | GC-MS | Agilent Technologies | 6890N/5975C | US00042346 | Chemstation E.02.00+SP1 | Yes | 4/1/01 | 9/9/11 | Yes | Yes | 0 | 1 | OEM spec | performance test results | 0.5 | ||||||||
| 73 | 1016949 | CFSAN | College Park, MD 20740 | GC-MS | Agilent Technologies | 6890N/5973Network | US00028403 | Chemstation E.02.00+SP1 | Yes | 9/9/11 | Yes | Yes | 0 | 1 | OEM spec | performance test results | 0.5 | |||||||||
| 74 | none | CFSAN | College Park, MD 20740 | GC-MS | Varian Instruments | 320-MS | MS0906W040 | LC | MS workstation 6.9.2 | Yes | 7/29/09 | Yes | Yes | 0 | 2 | n/a | signature | 0.5 | ||||||||
| 75 | CFSAN | College Park, MD 20740 | MS | AB Sciex | 5500 QTrap | AU10870902 | Analyst 1.5.1 | Yes | 7/1/09 | 6/1/12 | No | Yes | 0 | 2 | per Instrument SOP | signature | 0.5 | |||||||||
| 76 | 5107312 | CFSAN | College Park, MD 20740 | MS | Waters | Quattro Premier XE | VAB327 | Acquity | E05UPB849M, E05UPS826N | MassLynx | No | 10/10/05 | Yes | Yes | 0 | 3 | per Instrument SOP | signature | 0.5 | |||||||
| 77 | CFSAN | College Park, MD 20740 | UPLC | Waters | Acquity Solvent Manager | E 05UPB 849M | MassLynx | No | 10/10/05 | Yes | Yes | 0 | 3 | per Instrument SOP | signature | 1.0 | ||||||||||
| 78 | CFSAN | College Park, MD 20740 | UPLC | Waters | Acquity Sample Manager | E 05UPS 826N | MassLynx | No | 10/10/05 | Yes | Yes | 0 | 3 | per Instrument SOP | signature | 1.0 | ||||||||||
| 79 | 5107312 | CFSAN | College Park, MD 20740 | MS | Waters | QUATTRO PREMIER XE | VAB327 | MassLynx 4.1 | Yes | 10/1/05 | Yes | Yes | 0 | 2 | OEM spec | signature | 0.5 | |||||||||
| 80 | CFSAN | College Park, MD 20740 | UPLC | Waters | ACQUITY | F09UPB748M(Pump) | ICOPS | Yes | 6/1/09 | Yes | Yes | 0 | 2 | per Instrument SOP | signature | 1.0 | ||||||||||
| 81 | CFSAN | College Park, MD 20740 | UPLC | Waters | ACQUITY pump | F09UPB745M | ICOPS | Yes | 6/1/09 | Yes | Yes | 0 | 2 | per Instrument SOP | signature | 1.0 | ||||||||||
| 82 | CFSAN | College Park, MD 20740 | GC-MS | Agilent Technologies | 7000 | US10336303 | 1100 | DE1100326 | ChemStation | Yes | 6/1/10 | 12/1/11 | Yes | Yes | 0 | 3 | per Instrument SOP | signature | 0.5 | |||||||
| 83 | 1014062 | CFSAN | College Park, MD 20740 | LC-MS | Thermo Fisher | Exactive | SN01179P (Exactive), 925097 (Accela 1250 pump), 930131 (PDA), 195346 (Thermopal) | Accela 1250 | 925097 (Accela 1250 pump), 930131 (PDA), 195346 (Thermopal) | Excalibur | Yes | 6/1/10 | 12/1/11 | Yes | Yes | 1 | 1 | OEM spec | signature | 0.5 | ||||||
| 84 | 5059423 | CFSAN | College Park, MD 20740 | LC-MS | AB Sciex | 4000 QTrap | AR22590808 (Qtrap),L2030461150 (degasser), L2043460277 (pump), L20434600251 (pump), L2045460103 (autosampler), L20234651706 (communication module), L20214650386 (column oven), 4341564-54 (aircompressor), LCMS-1112 (N2 generator) | Shimadzu Prominence | L2030461150 (degasser), L2043460277 (pump), L20434600251 (pump), L2045460103 (autosampler), L20234651706 (communication module), L20214650386 (column oven), 4341564-54 (aircompressor), LCMS-1112 (N2 generator) | Analyst 1.5.1 | Yes | 8/1/08 | Yes | Yes | 1 | 1 | OEM spec | signature | 0.5 | |||||||
| 85 | 1014436 | CFSAN | College Park, MD 20740 | GC-MS | Agilent Technologies | 6890N/5973Network | US10210124 | GC | Chemstation E.02.00+SP1 | Yes | 3/27/02 | Yes | Yes | 0 | 3 | signature post instrument SOP | signature | 0.5 | ||||||||
| 86 | 5107297 | CFSAN | College Park, MD 20740 | ICP-MS | Agilent Technologies | 7500CE | JP51201771 | LC | Chem Station B.03.04 | No | 6/1/06 | Yes | Yes | 0 | 2 | OEM Spec | signature | 0.5 | ||||||||
| 87 | 1019891 | CFSAN | College Park, MD 20740 | ICP-MS | Agilent Technologies | 7700X | JP10290507 | Mass Hunter B.01.01 | No | 10/1/10 | 10/1/11 | Yes | Yes | 0 | 2 | OEM Spec | signature | 0.5 | ||||||||
| 88 | 1014167 | CFSAN | College Park, MD 20740 | MS | Waters | Q-TOF PREMIER | HAA180 | Acquity | F09UPA304M | MassLynx 4.1 | Yes | 8/1/06 | Yes | Yes | 1 | 1 | OEM spec | Signature | 0.5 | |||||||
| 89 | 5059538 | CFSAN | College Park, MD 20740 | UPLC | Waters | Acquity | F09UPA304M | ICOPS | No | 6/1/06 | Yes | Yes | 0 | 2 | OEM spec | Signature | 1.0 | |||||||||
| 90 | CFSAN | College Park, MD 20740 | LC | Agilent Technologies | 1200 | DE62957062 | Analyst/MassLynx/ChemStation | 11/1/04 | Yes | OEM approved | 0 | 2 | OEM spec | Signature | 1.0 | |||||||||||
| 91 | CFSAN | College Park, MD 20740 | LC | Agilent Technologies | 1200 | DE62976806 | Analyst/MassLynx/ChemStation | 7/29/10 | Yes | OEM approved | 0 | 2 | OEM spec | Signature | 1.0 | |||||||||||
| 92 | 5059560 | CFSAN | College Park, MD 20740 | GC-MS | Thermo Fisher | TSQ QUANTUM GC | TQU02462, TQU02462 (MS), 20097496 (GC), 20096478 (AS) | GC and A/S | Excalibur | Yes | 12/1/09 | 12/1/10 | Yes | Yes | 1 | 1 | 100 fg OFN EI 500/1 m/z 241 SRM | signature | 0.5 | |||||||
| 93 | 1015811 | CFSAN | College Park, MD 20740 | GC-MS | Varian Instruments | CP 3800/Saturn 2200 ion trap | 09782/4226 | GC | G1888 Headspace Sampler | IT00850004 | Varian MS Workstation, Version 6.6 | Yes | 2/1/03 | Yes | Yes | 0 | 1 | OEM spec | signature | 0.5 | ||||||
| 94 | 1019729 | CFSAN | College Park, MD 20740 | autosampler | Agilent Technologies | G1888 Headspace Sampler | IT00850004 | GC | Headspace SW for MSD, B01.01 | Yes | 3/16/09 | Yes | Yes | 0 | 1 | OEM spec | signature | 0.5 | ||||||||
| 95 | CFSAN | College Park, MD 20740 | GC-MS | JEOL | ACCUTOF-DART | MS10620041 | MassCenterMain1.3.1/TSPPro3.0 | Yes | 11/1/09 | Yes | Yes | 1 | 2 | instrument SOP | signature | 0.5 | ||||||||||
| 96 | CFSAN | College Park, MD 20740 | LC-MS | Waters | QUATTRO PREMIER | VAA019 | LC | NANO Acquity | K06NPS 207M | MassLynx 4.1 | Yes | 4/1/05 | Yes | Yes | 0 | 3 | OEM spec | Signature | 0.5 | |||||||
| 97 | CFSAN | College Park, MD 20740 | Nano-LC | Waters | NANO Acquity | K06NPS 207M | ICOPS | 11/1/06 | Yes | Yes | 1 | 2 | OEM spec | Signature | 0.5 | |||||||||||
| 98 | ||||||||||||||||||||||||||
| 99 | ORA | JAMAICA NY 11433 | LC-MS | Thermo Finnigan | LCQ DECA XP BENCHTOP MS | LDP00105 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 100 | ORA | CINCINNATI OH 45237 | LC-MS | Thermo Finnigan | LCQ DECA XP BENCHTOP MS | LDP00106 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 101 | ORA | IRVINE CA 92612 | LC-MS | Thermo Finnigan | LCQ DECA XP BENCHTOP MS | LDP00108 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 102 | ORA | DENVER CO 80225 | LC-MS | Thermo Finnigan | LCQ DECA XP BENCHTOP MS | LDP00109 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 103 | ORA | BOTHELL WA 98021 | LC-MS | Thermo Finnigan | LCQ DECA XP BENCHTOP MS | LDP00110 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 104 | ORA | ATLANTA GA 30309 | LC-MS | Thermo Finnigan | LCQ DECA XP BENCHTOP MS | LDP00111 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 105 | ORA | JEFFERSON AR 72079-9502 | LC-MS | Thermo Finnigan | LCQ DECA XP BENCHTOP MS | LDP00112 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 106 | ORA | LENEXA KS 66214 | LC-MS | Thermo Finnigan | LCQ DECA XP BENCHTOP MS | LDP00113 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 107 | ORA | CINCINNATI OH 45237 | LC-MS | Thermo Finnigan | LCQ DECA XP PLUS | LDP00196 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 108 | ORA | JAMAICA NY 11433 | LC-MS | Thermo Finnigan | LCQ DECA XP PLUS | LDP00198 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 109 | ORA | JEFFERSON AR 72079 | LC-MS | Thermo Finnigan | LCQ DECA XP PLUS | LDP00462 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 110 | ORA | DENVER CO 80225 | LC-MS | Thermo Finnigan | TSQ QUANTUM SYSTEM | TQU00253 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 111 | ORA | LENEXA KS 66214 | LC-MS | Thermo Finnigan | TSQ QUANTUM SYSTEM | TQU00288 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 112 | ORA | JEFFERSON AR 72079 | LC-MS | Thermo Finnigan | TSQ QUANTUM SYSTEM | TQU00294 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 113 | ORA | JAMAICA NY 11433 | LC-MS | Thermo Finnigan | TSQ QUANTUM | TQU00298 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 114 | ORA | ATLANTA GA 30309 | LC-MS | Thermo Finnigan | Finnigan TSQ Quantum Discovery | TQU00482 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 115 | ORA | DENVER CO 80225 | LC-MS | Thermo Finnigan | TSQ Quantum Access | TQU01612 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 116 | ORA | JEFFERSON AR 72079-9502 | GC-MS | Agilent | 5973 Turbo System | US297656 73406 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 117 | ORA | JEFFERSON AR 72079-9502 | GC-MS | Agilent | 5973 Turbo System | US297656 40139 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 118 | ORA | JEFFERSON AR 72079-9502 | GC-MS | Agilent | 5973 Turbo System | US297656 12259 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 119 | ORA | JEFFERSON AR 72079-9502 | GC-MS | Agilent | 5973 Diffusion System | US297656 39343 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 120 | ORA | JEFFERSON AR 72079-9502 | GC-MS | Agilent | 5973 Diffusion System | US297656 75108 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 121 | ORA | JEFFERSON AR 72079-9502 | GC-MS | Agilent | 5973 Turbo System | US297656 87251 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 122 | ORA | JEFFERSON AR 72079-9502 | GC-MS | Agilent | 5973 Diffusion System | US297656 39438 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 123 | ORA | JEFFERSON AR 72079-9502 | GC-MS | Agilent | 5973 Diffusion System | US297656 60629 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 124 | ORA | JEFFERSON AR 72079-9502 | GC-MS | Agilent | 5975 Turbo System | US297656 73406 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 125 | ORA | JEFFERSON AR 72079-9502 | GC-MS | Agilent | 5975 Turbo System | US297656 60629 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 126 | ORA | DENVER CO 80225 | GC-MS | Agilent | 5973 Turbo System | MS-20118 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 127 | ORA | DENVER CO 80225 | GC-MS | Agilent | 5975 Turbo System Enhanced Features | GCMS-33455 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 128 | ORA | LENEXA KS 66214 | GC-MS | Agilent | 5973 Turbo System | US297138 31001 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 129 | ORA | LENEXA KS 66214 | GC-MS | Agilent | 5973 Diffusion System | US105440 43010 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 130 | ORA | LENEXA KS 66214 | GC-MS | Agilent | 5973 Diffusion System | US105440 59063 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 131 | ORA | LENEXA KS 66214 | GC-MS | Agilent | 5973 Turbo System | US297138 72167 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 132 | ORA | LENEXA KS 66214 | GC-MS | Agilent | 5975 Turbo System | GCMS-33674 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 133 | ORA | ALAMEDA, CA 94502 | GC-MS | Agilent | 5975 Turbo System | WTY-0302520546 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 134 | ORA | ALAMEDA, CA 94502 | GC-MS | Agilent | 5975 Turbo System | GCMS-30876 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 135 | ORA | ALAMEDA, CA 94502 | GC-MS | Agilent | 5975 Turbo System | MS-60485 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 136 | ORA | JAMAICA NY 11433 | GC-MS | Agilent | 5973 Diffusion System | US105440-29063 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 137 | ORA | JAMAICA NY 11433 | GC-MS | Agilent | 5973 Diffusion System | US105440-82327 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 138 | ORA | JAMAICA NY 11433 | GC-MS | Agilent | 5973 Diffusion System | US105440-55570 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 139 | ORA | JAMAICA NY 11433 | GC-MS | Agilent | 5973 Diffusion System | US105440-38553 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 140 | ORA | JAMAICA NY 11433 | GC-MS | Agilent | 5973 Turbo System | US105440-60081 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 141 | ORA | JAMAICA NY 11433 | GC-MS | Agilent | 5973 Turbo System | US105440-96974 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 142 | ORA | JAMAICA NY 11433 | GC-MS | Agilent | 5973 Diffusion System | US296774 54597 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 143 | ORA | ATLANTA GA 30309 | GC-MS | Agilent | 5973 Diffusion System | US105440 92312 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 144 | ORA | ATLANTA GA 30309 | GC-MS | Agilent | 5973 Diffusion System | US105440 61516 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 145 | ORA | ATLANTA GA 30309 | GC-MS | Agilent | 5973 Diffusion System | US105440 15539 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 146 | ORA | ATLANTA GA 30309 | GC-MS | Agilent | 5973 Turbo System | US105440 71414 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 147 | ORA | ATLANTA GA 30309 | GC-MS | Agilent | 5973 Diffusion System | US105440 42504 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 148 | ORA | ATLANTA GA 30309 | GC-MS | Agilent | 5973 Diffusion System | US105440 71297 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 149 | ORA | ATLANTA GA 30309 | GC-MS | Agilent | 5973 Turbo System | US105440 64237 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 150 | ORA | ATLANTA GA 30309 | GC-MS | Agilent | 5973 Turbo System | US105440 16384 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 151 | ORA | ATLANTA GA 30309 | GC-MS | Agilent | 5973 Turbo System | US296967 56286 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 152 | ORA | ATLANTA GA 30309 | GC-MS | Agilent | 5973 Turbo System | GCMS-33532 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 153 | ORA | ATLANTA GA 30309 | GC-MS | Agilent | 5973 Turbo System | GCMS-30711 | 9/1/11 | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 154 | ORA | BOTHELL WA 98021 | GC-MS | Agilent | 5973 Diffusion System | MS1-43876 | N/A | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 155 | ORA | BOTHELL WA 98021 | GC-MS | Agilent | 5973 Turbo System | MS-82627 | N/A | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 156 | ORA | BOTHELL WA 98021 | GC-MS | Agilent | 5973 Diffusion System | GCMS-43707 | N/A | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 157 | ORA | BOTHELL WA 98021 | GC-MS | Agilent | 5973 Turbo System | MS3-53929 | N/A | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 158 | ORA | BOTHELL WA 98021 | GC-MS | Agilent | 5973 Diffusion System | GCMS-40604 | N/A | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 159 | ORA | BOTHELL WA 98021 | GC-MS | Agilent | 5975 Diffusion System | GCMS-10152 | N/A | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 160 | ORA | BOTHELL WA 98021 | GC-MS | Agilent | 5975 Diffusion System Adv Funct | GCMS-19881 | N/A | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 161 | ORA | BOTHELL WA 98021 | GC-MS | Agilent | 5975 Turbo System | GCMS-33745 | N/A | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 162 | ORA | IRVINE CA 92612 | GC-MS | Agilent | 5973 Diffusion System | GCMS-44058 | N/A | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 163 | ORA | IRVINE CA 92612 | GC-MS | Agilent | 5973 Turbo System | PSW-GEN-E-010 | N/A | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 164 | ORA | IRVINE CA 92612 | GC-MS | Agilent | 5975 Turbo System | GCMS-40526 | N/A | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 165 | ORA | IRVINE CA 92612 | GC-MS | Agilent | 5973 Diffusion System | US363857 21569 | N/A | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 166 | ORA | IRVINE CA 92612 | GC-MS | Agilent | 5973 Diffusion System | US363857 47991 | N/A | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 167 | ORA | IRVINE CA 92612 | GC-MS | Agilent | 5973 Turbo System | US363857 15562 | N/A | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 168 | ORA | IRVINE CA 92612 | GC-MS | Agilent | 5973 Diffusion System | US105440 99144 | N/A | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 169 | ORA | IRVINE CA 92612 | GC-MS | Agilent | 5973 Diffusion System | US105440 88931 | N/A | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 170 | ORA | IRVINE CA 92612 | GC-MS | Agilent | 5973 Diffusion System | US105440 71137 | N/A | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 171 | ORA | IRVINE CA 92612 | GC-MS | Agilent | 5973 Diffusion System | US105440 52928 | N/A | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 172 | ORA | IRVINE CA 92612 | GC-MS | Agilent | 5973 Diffusion System | US105440 77896 | N/A | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| 173 | ORA | IRVINE CA 92612 | GC-MS | Agilent | 5973 Diffusion System | US105440 30490 | N/A | Yes | Yes | 2 | 1 | instrument SOP | Quality Mgmt System | 0.5 | ||||||||||||
| Definitions | Definitions | Definitions | ||||||||||||||||||||||||
| LEVEL 1: Regulatory Analysis. 2-working day response | SIGNATURE: Point of contact accepts "as is" when technician is finished | SIGNATURE: The technician signs a report that the service call was closed | ||||||||||||||||||||||||
| : | LEVEL 2: Research Analysis. 5-7 working day response | OEM SPECIFICATIONS: The technician demonstrates that an appropriate OEM specification can be met | THIRD PARTY SERVICE REPORT: The technician provides the 3rd party's standard service report on what was done and the outcome | |||||||||||||||||||||||
| LEVEL 3: Analytical Capacity. 10 - 20 working day response | INSTRUMENT SOP: The technician demonstrates that a requirement from the instrument SOP can be met | PERFORMANCE TEST RESULTS: The technicican provides copies of the test data which were used to meet the acceptance standard | ||||||||||||||||||||||||
| METHOD SOP: The technician demonstrates that suitability tests from a method SOP which previously were met can still be met | QUALITY MANAGEMENT SYSTEM: The technician completes documentation required by local facility using a form provided by the PoC. | |||||||||||||||||||||||||
| OQ/PQ SCRIPT: The technician carries out an Operational Qualification / Performance Qualification script from a Quality Management Program which was provided in advance | ||||||||||||||||||||||||||
| PRE-TEST: FDA or the technician carries out a test before carrying out maintenance, then repeats the test afterward |
File details come from the government source that posted it. Updated .