Home › Device types › JWY
Manual Antimicrobial Susceptibility Test Systems
FDA product code JWY · Class 2 · Microbiology
402
Registered devices
153
Adverse events
78
Recalls
441
510(k) clearances
Devices with this code
Etest® TOBRAMYCIN — BIOMERIEUX SASensititre — TREK DIAGNOSTIC SYSTEMS LIMITEDSensititre — TREK DIAGNOSTIC SYSTEMS LIMITEDSensititre — TREK DIAGNOSTIC SYSTEMS LIMITEDLiofilchem MTS (MIC Test Strip) — LIOFILCHEM SRLETEST® Ampicillin/Sulbactam (2/1) (AB) — BIOMERIEUX SAMicroScan — Beckman Coulter, Inc.ETEST® Doripenem (DOR) — BIOMERIEUX SASensititre — TREK DIAGNOSTIC SYSTEMS LIMITEDMicroScan — Beckman Coulter, Inc.Liofilchem MIC Test Strip (MTS) — LIOFILCHEM SRLEtest® CEFTRIAXONE — BIOMERIEUX SAMicroScan — Beckman Coulter, Inc.Sensititre — TREK DIAGNOSTIC SYSTEMS LIMITEDMicroScan — Beckman Coulter, Inc.Liofilchem MIC Test Strip (MTS) — LIOFILCHEM SRLETEST® Trimethoprim/Sulfamethoxazole (1/19) (TS) — BIOMERIEUX SAEtest® GATIFLOXACIN — BIOMERIEUX SAMicroScan — Beckman Coulter, Inc.Liofilchem MIC Test Strip (MTS) — LIOFILCHEM SRLMicroScan — Beckman Coulter, Inc.MicroScan — Beckman Coulter, Inc.ETEST® Aztreonam (AT) — BIOMERIEUX SAETEST® Cefoxitin (FX) — BIOMERIEUX SA
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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