A012 Certificate of Conformance LFI Strips.pdf
PDF 108 KB Posted
- Attached to
- Manufacturing of LFI Strips
- Solicitation number
- W911SR-23-R-0005
About this file
This document is a Contract Data Requirements List (CDRL) for a federal contract requiring the manufacturing of lateral flow immunoassay (LFI) strips. The CDRL specifies that the contractor must provide a Certificate of Conformance (CoC) with each production lot of LFI strips delivered. The CoC template must be approved by the government and include test results demonstrating the LFI strips meet performance criteria for assay sensitivity, specificity, antigen dose response, and non-specific reactivity. It must also specify the LFI strip dimensions and placement of test and control lines. The CoC is due with each lot delivery and shall be submitted electronically to two Army contracting personnel. The related solicitation is for the Department of the Army to procure LFI strip manufacturing services under solicitation number W911SR-23-R-0005.
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DD FORM 1423-1, FEB 2001
CONTRACT DATA REQUIREMENTS LIST
(1 Data Item)
PREVIOUS EDITION MAY BE USED.
Form Approved OMB No. 0704-0188
The public reporting burden for this collection of information is estimated to average 110 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden, to the Department of Defense, Executive Services and Communications Directorate (0704-0188). Respondents should be aware that notwithstanding any other provision of law, no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. Please do not return your form to the above organization. Send completed form to the Government Issuing Contracting Officer for the Contract/PR No. listed in Block E.
A. CONTRACT LINE ITEM NO. B. EXHIBIT C. CATEGORY:
TDP ________ TM _______ OTHER
D. SYSTEM/ITEM E. CONTRACT/PR NO. F. CONTRACTOR
1. DATA ITEM NO. 2. TITLE OF DATA ITEM 3. SUBTITLE
4. AUTHORITY (Data Acquisition Document No.) 5. CONTRACT REFERENCE 6. REQUIRING OFFICE
7. DD 250 REQ
8. APP CODE
9. DIST STATEMENT
REQUIRED
10. FREQUENCY
11. AS OF DATE
12. DATE OF FIRST SUBMISSION
13. DATE OF SUBSEQUENT
SUBMISSION
14. DISTRIBUTION
a. ADDRESSEE
b. COPIES
Draft Final
Reg Repro
15. TOTAL
16. REMARKS
17. PRICE GROUP
18. ESTIMATED
TOTAL PRICE
G. PREPARED BY H. DATE I. APPROVED BY J. DATE
Page of Pages
| A_CONTRACT_LINE_ITEM_NO: TBD |
| B_EXHIBIT: |
| TDP: |
| TM: |
| OTHER: x |
| DSYSTEMITEM: |
| E_CONTRACTPR_NO: TBD |
| FCONTRACTOR: TBD |
| 1_DATA_ITEM_NO: A012 |
| 2_TITLE_OF_DATA_ITEM: Certificate of Conformance |
| 3_SUBTITLE: |
| 4_AUTHORITY_Data_Acquisit: DI-MISC-81356A |
| 5_CONTRACT_REFERENCE: |
| 6_REQUIRING_OFFICE: JPL CBRND EB-DBPAO |
| 7_DID_250_REQ: |
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| 10_FREQUENCY: ASREQ |
| 11_AS_OF_DATE: award date |
| 12_DATE_OF_FIRST_SUBMISSI: see blk 16 |
| 13_DATE_OF_SUBSEQUENT_SUB: see blk 16 |
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| 16_REMARKS: Blk 4. DIDs can be obtained from https://quicksearch.dla.mil/qsSearch.aspx. |
The contractor shall provide a Certificate of Conformance (CoC) with each lot of lateral flow immunoassay (LFI) strips. The contractor shall use a CoC template approved by the Government.
The CoC shall include:
1. LFI Performance Criteria:
a. Assay Sensitivity Test Result
b. Specificity Test Results
c. Antigen Dose Response Results
d. Non-Specific Reactivity Test Results
2. LFI Strip Physical Specifications:
a. Test Line and Control Line Placements
b. LFI Strip Length
c. LFI Strip Thickness
d. LFI Strip Thickness Over Sample Pad
Blk 13. The CoC shall be provided with delivery of each production lot of LFI strips.
Blk 14. and Blk 15. Submit via email in Microsoft Office format to:
susan.e.ruzicka2.civ@army.mil and bryan.d.necciai.civ@army.mil
| 17_PRICE_GROUP: | |
| ESTIMATED_TOTAL_PRICE: | |
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| H_DATE: 1/25/2023 | |
| 1_APPROVED_BY: | |
| J_DATE: 1/25/2023 | |
| Page: | |
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| Reset: | |
| reg38t: 12 | |
| 2023-01-25T12:56:26-0500 | |
| REDMOND.BRADY.WAYNE.1280051590 |
| 2023-01-25T15:55:41-0500 | |
| NECCIAI.BRYAN.DAVID.1267973586 |
File details come from the government source that posted it. Updated .