VITEK 2 AST-Gram Negative Omadacycline (=16 µg/mL)

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

BioMerieux, Inc.

The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vitek 2 Ast-gram Negative Omadacycline (=16 µg/ml).

Pre-market Notification Details

Device IDK213931
510k NumberK213931
Device Name:VITEK 2 AST-Gram Negative Omadacycline (=16 µg/mL)
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant bioMerieux, Inc. 595 Anglum Road Hazelwood,  MO  63042
ContactDebra Broyles
CorrespondentNathan Hardesty
bioMerieux, Inc. 595 Anglum Road Hazelwood,  MO  63042
Product CodeLON  
CFR Regulation Number866.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-16
Decision Date2022-06-03

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