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NG-Test CARBA 5
NG BIOTECH · Model Kit of 20 tests for US · UDI-DI 03701077400133
PTJ
Prescription
1
510(k) clearances
14
Adverse events
1
Recalls
5
Facilities
Description
Rapid test for the detection of carbapenemases KPC, OXA, VIM, IMP and NDM in a bacterial colony from culture.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-05-16 | Biomerieux Inc | The investigation demonstrated a high rate of very major errors (resistant isolates calling susceptible) with the VITEK 2 AST-GN colistin (cs01n) compared to agar dilution (the r |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.