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Company-Registration
2004365094
Device Listing 2004365094
Listing Summary
#
Listing key
2004365094
Premarket submission
K212849
Device
VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)
Applicant
Biomérieux, Inc.
Product code
LON
Decision date
2022-02-04
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
9759
1950204
1950204
BIOMERIEUX, INC.
1
Y
2026-01-01
595 ANGLUM RD. HAZELWOOD MO US 63042
330867
3031977134
3031977134
bioMerieux, Inc.
1
N
2026-01-01
3015 Carrington Mill Blvd Morrisville NC US 27560