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
25–48 of 441
Cleared Aug 30, 2023
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml
K231988
Thermo Fisher Scientific
Microbiology · 56d
Cleared Aug 25, 2023
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL
K231994
Thermo Fisher Scientific
Microbiology · 51d
Cleared Jun 30, 2023
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)
K230935
Thermo Fisher Scientific
Microbiology · 88d
Cleared May 18, 2023
ComASP Cefiderocol 0.008-128
K230479
Liofilchem S. R. L.
Microbiology · 85d
Cleared Mar 21, 2023
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae)
K223844
Thermo Fisher Scientific
Microbiology · 89d
Cleared Dec 20, 2021
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml
K203741
Thermo Fisher Scientific
Microbiology · 363d
Cleared Nov 12, 2021
ETEST Fosfomycin (FO) (0.032-512 µg/mL)
K210757
Biomerieux S.A.
Microbiology · 242d
Cleared Oct 20, 2021
MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL
K211672
Liofilchem S. R. L.
Microbiology · 141d
Cleared Jul 23, 2021
Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL)
K202612
Thermo Fisher Scientific
Microbiology · 317d
Cleared May 18, 2021
MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)
K202423
Beckman Coulter, Inc.
Microbiology · 266d
Cleared May 07, 2020
ETEST Plazomicin (PLZ) (0.016-256 µg/mL)
K200512
Biom?rieux SA
Microbiology · 66d
Cleared Apr 06, 2020
MTS Lefamulin 0.016- 256 µg/mL
K200308
Liofilchem S. R. 1.
Microbiology · 60d
Cleared Mar 20, 2020
MTS Omadacycline 0.002 - 32 ug/mL
K200180
Liofilchem S. R. L.
Microbiology · 56d
Cleared Mar 12, 2020
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml
K193538
Thermo Fisher Scientific
Microbiology · 83d
Cleared Jan 08, 2020
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL
K193024
Thermo Fisher Scientific
Microbiology · 70d
Cleared Nov 26, 2019
ETEST Delafloxacin (DFX) (0.002-32 µg/mL)
K192738
Biomerieux S.A.
Microbiology · 60d
Cleared Nov 14, 2019
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL)
K192355
Beckman Coulter, Inc.
Microbiology · 77d
Cleared Nov 06, 2019
Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml
K192729
Thermo Fisher Scientific
Microbiology · 40d
Cleared Oct 31, 2019
MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL
K192345
Liofilchem S. R. L.
Microbiology · 63d
Cleared Oct 16, 2019
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL
K192250
Thermo Fisher Scientific
Microbiology · 58d
Cleared Sep 27, 2019
ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)
K192050
Biomerieux S.A.
Microbiology · 58d
Cleared Sep 04, 2019
MTS Imipenem 0.016-256 µg/mL
K191908
Liofilchem S. R. L.
Microbiology · 50d
Cleared Aug 23, 2019
MTS Imipenem-relebactam 0.002/4-32/4 µg/mL
K191809
Liofilchem S. R. L.
Microbiology · 49d
Cleared Aug 22, 2019
ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
K191953
Biomerieux S.A.
Microbiology · 31d