bioMerieux, Inc. - FDA 510(k) Cleared Devices

Cleared Jun 14, 2021

VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)

K211136 · LON

Microbiology · 59d

Cleared Sep 28, 2020

VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)

K193299 · LON

Microbiology · 306d

Cleared Apr 28, 2020

VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)

K200590 · LON

Microbiology · 53d

Cleared Mar 13, 2020

VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)

K193572 · LON

Microbiology · 81d

Cleared Feb 14, 2020

VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL)

K193567 · LON

Microbiology · 53d

Cleared Oct 31, 2019

Vitek Densichek

K192110 · LON

Microbiology · 87d

Cleared Aug 05, 2019

VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)

K191766 · LON

Microbiology · 35d

Cleared Jun 06, 2019

VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)

K190616 · LON

Microbiology · 87d

Cleared May 15, 2019

BACT/ALERT MP Reagent System

K190405 · MDB

Microbiology · 85d

Cleared Mar 12, 2019

VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)

K183524 · LON

Microbiology · 83d

Cleared Mar 07, 2019

VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL)

K183551 · LON

Microbiology · 77d

Cleared Feb 26, 2019

VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >=64/8 µg/mL)

K183360 · LON

Microbiology · 84d

Cleared Feb 20, 2019

VITEK 2 AST-Gram Negative Imipenem (= 16 ug/mL)

K183415 · LON

Microbiology · 72d

Cleared Feb 11, 2019

BacT/ALERT FA Plus

K183166 · MDB

Microbiology · 88d

Cleared Dec 21, 2018

VITEK MS

K181412 · QBN

Microbiology · 205d

Cleared Dec 10, 2018

VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance

K181766 · LON

Microbiology · 160d

Cleared Jun 20, 2018

VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)

K181368 · NGZ

Microbiology · 28d

Cleared Dec 19, 2017

VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL

K172944 · LON

Microbiology · 84d

Cleared Dec 08, 2017

VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)

K172731 · LON

Microbiology · 88d

Cleared Sep 15, 2017

Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)

K172150 · JWY

Microbiology · 60d

Cleared Jul 22, 2017

VITEK MS

K162950 · PEX

Microbiology · 271d

Cleared Jun 21, 2017

VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)

K162737 · LON

Microbiology · 264d

Cleared May 31, 2017

Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)

K170670 · JWY

Microbiology · 86d

Cleared Mar 28, 2017

BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO

K161816 · MDB

Microbiology · 270d

Cleared Mar 13, 2017

VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL)

K163563 · LON

Microbiology · 84d