Home › Device types › JWY
Manual Antimicrobial Susceptibility Test Systems
FDA product code JWY · Class 2 · Microbiology
405
Registered devices
153
Adverse events
78
Recalls
441
510(k) clearances
Devices with this code
Etest® CEFOTAXIME — BIOMERIEUX SAETEST® Ceftaroline (CPT) — BIOMERIEUX SALiofilchem MTS (MIC Test Strip) — LIOFILCHEM SRLETEST® Imipenem (IP) — BIOMERIEUX SAETEST® Ertapenem (ETP) — BIOMERIEUX SASensititre — TREK DIAGNOSTIC SYSTEMS LIMITEDMicroScan — Beckman Coulter, Inc.Liofilchem MTS (MIC Test Strip) — LIOFILCHEM SRLSensititre — TREK DIAGNOSTIC SYSTEMS LIMITEDLiofilchem Mic Test Strip (MTS) — LIOFILCHEM SRLSensititre — TREK DIAGNOSTIC SYSTEMS LIMITEDLiofilchem MIC Test Strip (MTS) — LIOFILCHEM SRLETEST® Azithromycin (AZ) — BIOMERIEUX SAETEST® Cefuroxime (XM) — BIOMERIEUX SAETEST® Amoxicillin/clavulanic acid (2/1) (XL) — BIOMERIEUX SAEtest® GEMIFLOXACIN — BIOMERIEUX SAMicroScan — Beckman Coulter, Inc.Liofilchem MIC Test Strip (MTS) — LIOFILCHEM SRLETEST® Gentamicin (GM) — BIOMERIEUX SALiofilchem MTS (MIC Test Strip) — LIOFILCHEM SRLLiofilchem MTS (MIC Test Strip) — LIOFILCHEM SRLLiofilchem MTS (MIC Test Strip) — LIOFILCHEM SRLETEST® Imipenem/Relebactam (IPR) — BIOMERIEUX SALiofilchem MIC Test Strip (MTS) — LIOFILCHEM SRL
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-01 | Remel, Inc | Product may have an off color affecting perfomance |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
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