JWY · Class II · 21 CFR 866.1640

FDA Product Code JWY: Manual Antimicrobial Susceptibility Test Systems

FDA product code JWY covers manual antimicrobial susceptibility test systems.

These diagnostic systems are used to determine which antibiotics are effective against specific bacterial or fungal isolates from patient samples. Results guide clinicians in selecting appropriate antibiotic therapy, a critical step in managing infections and combating antimicrobial resistance.

JWY devices are Class II medical devices, regulated under 21 CFR 866.1640 and reviewed by the FDA Microbiology panel.

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic, Thermo Fisher Scientific and Liofilchem S. R. L..

441
Total
441
Cleared
89d
Avg days
1981
Since
441 devices
49–72 of 441
Cleared May 29, 2019
MTS Doxycycline 0.016 - 256 µg/mL
K190914
Liofilchem S. R. L.
Microbiology · 51d
Cleared May 01, 2019
ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)
K190154
Biomerieux S.A.
Microbiology · 91d
Cleared Apr 18, 2019
MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)
K190109
Beckman Coulter, Inc.
Microbiology · 85d
Cleared Mar 22, 2019
MTS Gentamicin 0.016 - 256 µg/mL
K190252
Liofilchem S. R. L.
Microbiology · 43d
Cleared Mar 19, 2019
MTS Ciprofloxacin 0.002 - 32 µg/mL
K183527
Liofilchem S. R. L.
Microbiology · 90d
Cleared Feb 15, 2019
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL
K183324
Thermo Fisher Scientific
Microbiology · 77d
Cleared Jan 11, 2019
ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)
K183031
Biomerieux S.A.
Microbiology · 71d
Cleared Jan 11, 2019
MTS Tetracycline 0.016 - 256 ug/mL
K183140
Liofilchem S. R. L.
Microbiology · 59d
Cleared Jan 04, 2019
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml
K183033
Thermo Fisher Scientific
Microbiology · 64d
Cleared Dec 20, 2018
MTS Levofloxacin 0.002 - 32 µg/mL
K183115
Liofilchem S. R. L.
Microbiology · 41d
Cleared Dec 14, 2018
MTS Omadacycline 0.002-32 µg/mL
K182922
Liofilchem S. R. L.
Microbiology · 56d
Cleared Nov 30, 2018
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL
K182797
Thermo Fisher Scientific
Microbiology · 60d
Cleared Nov 02, 2018
MTS Eravacycline 0.002 - 32 µg/mL
K182557
Liofilchem S. R. L.
Microbiology · 46d
Cleared Sep 13, 2018
MTS Penicillin 0.002- 32 µg/mL
K181889
Liofilchem S. R. L.
Microbiology · 62d
Cleared Aug 08, 2018
Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL
K181946
Thermo Fisher Scientific
Microbiology · 19d
Cleared Jul 31, 2018
MTS Plazomicin 0.016-256 µg/mL
K181708
Liofilchem S. R. L.
Microbiology · 33d
Cleared Jul 03, 2018
ETEST Telavancin (TLA) (0.002-32 ug/mL)
K180936
Biomerieux S.A.
Microbiology · 84d
Cleared May 18, 2018
Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL
K180886
Liofilchem S. R. L.
Microbiology · 44d
Cleared Apr 04, 2018
Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL
K180339
Liofilchem S. R. L.
Microbiology · 56d
Cleared Mar 15, 2018
Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL
K180330
Liofilchem S. R. L.
Microbiology · 37d
Cleared Feb 28, 2018
Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL
K173817
Liofilchem S. R. L.
Microbiology · 75d
Cleared Sep 15, 2017
Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)
K172150
bioMerieux, Inc.
Microbiology · 60d
Cleared May 31, 2017
Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)
K170670
bioMerieux, Inc.
Microbiology · 86d
Cleared Sep 16, 2015
MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)
K152346
Beckman Coulter, Inc.
Microbiology · 27d