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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: VITEK 2 GP Cefoxitin Screen
Classification Name: SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
Product Code: LON
Device Class: 2
Regulation Number: 866.1645
Medical Specialty: Microbiology
Registered Establishment Name: BIOMERIEUX, INC.
Registered Establishment Number: 1950204
Owner/Operator: BIOMERIEUX SA
Owner/Operator Number: 8020790
Establishment Operations: Manufacturer
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