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Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

FDA product code PTJ · Class 2 · Microbiology

4
Registered devices
14
Adverse events
1
Recalls
3
510(k) clearances

Devices with this code

NG-TEST CTX-M Multi — NG BIOTECHRAPIDEC® CARBA NP — BIOMERIEUX SANG-Test CARBA 5 — NG BIOTECHRAPIDEC® CARBA NP — BIOMERIEUX SA

Recent recalls

DateFirmReason
2017-05-16Biomerieux IncThe investigation demonstrated a high rate of very major errors (resistant isolates calling susceptible) with the VITEK 2 AST-GN colistin (cs01n) compared to

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