The Food and Drug Administration (FDA) is conducting a market survey to assess the availability and potential technical capability of all small businesses as defined by NAICS code 325413 to provide Vitek® consumables.
The FDA is a regulatory agency with responsibility for the safety and efficacy of drug, devices and other medical products. In support of this regulatory mission the ORA field laboratories, they conduct analysis using scientific instruments such as VIDAS, VITEK 2, and VITEK MS that require proprietary reagents, slides, strips and cards. These consumables, API 2E, API Listeria, SX2, Vidas salmonella, Listeria, Vidas set 2, QCV Vidas 60T, Vitek 2ANC, Vitek 2BCL, Vitek 26N, Vitek 2GP, Vitek MS DS and Vitek MS CHCA, are used in accordance with the manufacturers recommendations to achieve the goals of screening and identification confirmation of isolates associated with outbreaks.
The information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Respondents shall specify and document that their NAICS code is 325413 and provide proof of your business size.
This is a request for information and shall not be considered as a solicitation or as an obligation on the part of the Food and Drug Administration (FDA) for any future solicitation. Telephone inquiries will not be accepted.
All interested parties shall submit their capability statement to Julia Savage, FDA contracting office via email to Julia.email@example.com by April 5, 2021, 3 pm Eastern time.