Fully automated microbial enumeration system: Biomerieux TEMPO
Waiver type - Procurement: Nonavailability
Agency: FOOD AND DRUG ADMINISTRATION (7524) • Product Service Code (PSC) : 6640 | Last Modified: 08/30/2024
Procurement Summary
The Food and Drug Administration (FDA), Center for Food Safety and Nutrition (CFSAN), Division of Microbiology, Office of Regulatory Science requires an automated microbial instrument to test quality indicators of food safety. The fully automated instrument shall be able to automatically enumerate Aerobic mesophilic total flora, Bacillus cereus, Campylobacter, Coliforms, Escherichia coli (“e-coli”), Enterobacteriaceae, Lactic acid bacteria, Staphylococcus (coag+), yeast and mold from food or environmental samples, as manual enumeration of cells can be very laborious and time consuming. The instrument shall use cards for automatic enumerations of selected microbial cells, based on MPN (Most Probable Number method). The lab has found an instrument that will meet their needs: the TEMPO from Biomerieux.
Waiver Rationale Summary
Based on the results of the market research conducted and the results of the Sources Sought Notice (SSN) as well as the results of the RFQ, it is determined that an item which meets the Government’s need is not produced or manufactured in the United States in sufficient and/or reasonably available commercial quantities and of a satisfactory quality. A domestically manufactured item is not available to meet the FDA’s need.
Yes
No
Consistent with Policy
LABORATORY EQUIPMENT AND SUPPLIES
334516 - Analytical Laboratory Instrument Manufacturing
08/20/2024
75F40124P00355
75F40124Q124188
Post-solicitation
Instant Delivery Only
Individual Waiver
FOOD AND DRUG ADMINISTRATION