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 Ab Biodisk, Thermo Fisher Scientific and Trek Diagnostic Systems, Inc..
441
Total
441
Cleared
89d
Avg days
1981
Since
441 devices
Cleared
Oct 13, 2017
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL
Thermo Fisher Scientific
Microbiology
60d
Cleared
Sep 27, 2017
Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL
Liofilchem S. R. L.
Microbiology
76d
Cleared
Sep 15, 2017
Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)
bioMerieux, Inc.
Microbiology
60d
Cleared
Aug 30, 2017
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8µg/mL
Thermo Fisher Scientific
Microbiology
33d
Cleared
Aug 01, 2017
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 – 8 ug/mL
Thermo Fisher Scientific
Microbiology
40d
Cleared
Aug 01, 2017
Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL
Liofilchem S. R. L.
Microbiology
36d
Cleared
Jun 07, 2017
Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL
Liofilchem S. R. L.
Microbiology
85d
Cleared
May 31, 2017
Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)
bioMerieux, Inc.
Microbiology
86d
Cleared
May 25, 2017
Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL
Liofilchem S. R. L.
Microbiology
59d
Cleared
Mar 14, 2017
Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL
Liofilchem S. R. L.
Microbiology
89d
Cleared
Feb 22, 2017
Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL
Liofilchem S. R. L.
Microbiology
92d
Cleared
Dec 19, 2016
Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml
Liofilchem S. R. L.
Microbiology
68d
Cleared
Jul 12, 2016
Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL
Liofilchem S. R. L.
Microbiology
77d
Cleared
Jun 22, 2016
Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml
Liofilchem S. R. L.
Microbiology
190d
Cleared
Mar 31, 2016
Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL
Liofilchem S. R. L.
Microbiology
99d
Cleared
Dec 21, 2015
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL
Thermo Fisher Scientific
Microbiology
87d
Cleared
Sep 16, 2015
MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)
Beckman Coulter, Inc.
Microbiology
27d
Cleared
Aug 28, 2015
Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL)
Thermo Fisher Scientific
Microbiology
177d
Cleared
Jul 27, 2015
Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL)
Thermo Fisher Scientific
Microbiology
175d
Cleared
Apr 01, 2015
Sensititre Susceptibility plates
Thermo Fisher Scientific
Microbiology
135d
Cleared
Mar 05, 2015
The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml)
Thermo Fisher Scientific
Microbiology
83d
Cleared
Mar 02, 2015
Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml)
Thermo Fisher Scientific
Microbiology
193d
Cleared
Feb 19, 2015
Sensititre Susceptibility Plates
Thermo Fisher Scientific
Microbiology
86d
Cleared
Dec 23, 2014
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
Thermo Fisher Scientific
Microbiology
139d