SOLICITATION NOTICE
66 -- Tests kits for use with VITEK2® Instrumentation
- Notice Date
- 5/28/2014
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA1130858
- Archive Date
- 6/26/2014
- Point of Contact
- Beth A. Goldberg, Phone: 3018277153
- E-Mail Address
-
beth.goldberg@fda.hhs.gov
(beth.goldberg@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- FDA 1130858 Notice of Intent to Sole Source - Biomerieux The Food and Drug Administration intends to award a Sole Source firm-fixed price contract to Biomerieux, 100 Rodolphe Street, Durham, NC 27712 in accordance with FAR part 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. The purpose of this acquisition is to procure various tests kits for use with VITEK2® Instrumentation for a base year and four (4) one (1) year options. The FDA/ORA field laboratories require various test kits for use with VITEK2® Instrumentation for the identification of pathogens in food and environmental samples. The test cards must be compatible for use with the VITEK2® instrumentation existing in the field laboratories and must contain and meet the following specifications: • GN Cards Cat no. 21341 o For the in vitro identification of Enterbacteriaceae and a select group of glucose nonfermenting gram-negative organisms. o Each card must contain 64 WELLS o Each card must contain a pre-inserted transfer device o Each card must contain a unique barcode identifier o Each card must be covered with a labeled foil seal containing the lot number and expiration date o Reactive ingredients must contain APPA, ADO, PYRA, IARL, DCEL, BGAL, H2S, BNAG, AGLTP, DGLU, GGT, OFF, BGLU, DMAL, DMAN, DMNE, BXYL, BALAP, PROA, LIP, PLE, TYRA, URE, DSOR, SAC, DTAG, DTRE, CIT, MNT, 5KG, ILATK, AGLU, SUCT, NAGA, AGAL, PHOS, GLYA, ODC, LDC, 0DEC, IHISA, CMT, BGUR, 0129R, GGAA, IMLTA, ELLM, ILATA o The laboratories must be able to use the cards with the VITEK2 system • GP Cards Cat no. 21342 o For the identification of enterococci, streptococci, staphylocci, and a select group of gram-positive organisms. o Each card must contain 64 WELLS o Each card must contain a pre-inserted transfer device o Each card must contain a unique barcode identifier o Each card must be covered with a labeled foil seal containing the lot number and expiration date o Reactive ingredients must contain AMY, PIPLC, DXYL, ADH1, BGAL, AGLU, APPA, CDEX, ASPA, BGAR, AMAN, PHOS, LEUA, PROA, GBURR, AGAL, PYRA, BGUR, ALAA, TYRA, DSOR, URE, POLYB, DGAL, DRIB, ILATK, LAC, NAG, DMAL, BACI, NOVO, NC6.5, DMAN, DMNE, MBDG, PUL DRAF, 0129R, SAL, SAC, DTRE, ADH2S, OPTO. o The laboratories must be able to use the cards with the VITEK2 system • BCL Cards Cat no. 21345 o For the identification of Gram-positive microorganisms of the family Bacillaceae. o Each card must contain 64 WELLS o Each card must contain a pre-inserted transfer device o Each card must contain a unique barcode identifier o Each card must be covered with a labeled foil seal containing the lot number and expiration date o Reactive ingredients must contain BXYL, LYSA, ASPA, LEUA, PHEA, PROA, BGAL, PURA, AGAL, ALAA, TYRA, BNAG, APPA, CDEX, DGAL, GLYG, INO, MDG, ELLM, MDX, AMAN, MTE, GLYA, DMAN, DMNE, DMLZ, NAG, PLE, IRHA, GGLU, BMAN, PHC, PVATE, AGLU, DTAG, DTRE, INU, DGLU, DRIB, PSCNA, NACL6.5, KAN, OLD, ESC, TTZ, POLYBR. o The laboratories must be able to use the cards with the VITEK2 system • YST Cards Cat no. 21343 o For the identification of yeast species o Each card must contain a pre-inserted transfer device o Each card must contain a unique barcode identifier o Each card must be covered with a labeled foil seal containing the lot number and expiration date Biomerieux is the only responsible source because VITEK2® Instrumentation is manufactured by Biomerieux and the reagents are proprietary. The NAICS code is 334516 Analytical Laboratory Instrument Manufacturing This notice is not a request for competitive proposals. All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. It is anticipated that an award will be issued to Biomerieux, within approximately fifteen (15) days after the date of this notice unless the Government determines that any other organization has the capacity to meet this requirement. Response Date: 3:00 p.m. EST June 11, 2014. Please email responses to Beth Goldberg at beth.goldberg@fda.hhs.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA1130858/listing.html)
- Record
- SN03377797-W 20140530/140528234917-6932be2b0e6259b93fe45f8198309ae0 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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