Test Kits
Award Notice Posted
- Solicitation number
- FDA-15-SOL-1152408
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Awarded
- to Biomerieux Inc.
- Set-aside
- No set-aside
Opportunity facts
- Contract number
- HHSF223201510040I-HHSF22301003T Federal contract award
- NAICS code
- 325413 In-Vitro Diagnostic Substance Manufacturing
- PSC
- Not on record
- Place of performance
- Multiple, please see attached RFQ., United States
Notice details come from SAM.gov. Updated .
Notice text
The U.S. Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA) field laboratories currently perform over 120,000 individual analyses for the presence of pathogens in food. Isolates from these samples are identified and confirmed as pathogens using the Vitek Immunodiagnostic Assay System (VIDAS ) instrument. The VIDAS immunoassay instrument uses a single-dose, off-the-shelf, reagent strip system which contains the antigens or antibodies for the specific pathogen with all necessary reagents for the reaction. This solid phase system is both the pipettor and reagent transfer device and aspirates all reagents, eliminating sample or reagent cross-contamination. VIDAS uses the enzyme-linked flourescent assay (ELFA) principle which combines the enzyme-linked immunosorbent assay (ELISA) test method with a final fluorescent reading with an on-board QC program to validate its readings. ORA requires Salmonella, Listeria and QCV kits compatible with existing VIDAS instrumentation for continued analysis for a five (5) year ordering period.
Please see attached RFQ.
Files
| File | Type | Posted |
|---|---|---|
| 1152408_FBORFQ_08252015.pdf |
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