ClearanceBrief
Panels › Microbiology › Product code JST · Class 1

Kit, Fastidious Organisms

Regulation 866.2660

0510(k)s in 12 months (6 all time)
0recalls in 12 months (6 all time)
0recalls that name a 510(k)
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Top companies in JST

Company510(k)sRecalls
BioMerieux SA06
Austin Biological Laboratories20
Becton Dickinson Microbiology Systems10
Dms Products, Inc.10
Granite Diagnostics, Inc.10
Oxoid U.S.A., Inc.10
DateFirm and productCodeLinked 510(k)
Jan 4, 2023Biomerieux Inc
PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588
Open, Classified		 JSTNone listed
Jan 4, 2023Biomerieux Inc
PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586
Open, Classified		 JSTNone listed
Jan 4, 2023Biomerieux Inc
VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346
Open, Classified		 JSTNone listed
Mar 23, 2018BioMerieux SA
The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for use with the VITEK 2 Systems for the automated identification of most clinically significant fastidious organisms. The VITEK
Terminated		 JSTNone listed
Jan 23, 2018Biomerieux Inc
bioMrieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria a
Terminated		 JSTNone listed
May 22, 2017Biomerieux Inc
VITEK 2 Neisseria-Haemophilus identification card (NH), IVD, REF 21346, 20 cards per carton.
Terminated		 JSTNone listed

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