PTJClass II
Phenotypic Test Kit, Non-susceptible/elevated Mic Organisms, Cultured Isolates
Microbiology · 21 CFR 866.1640
Qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any Carbapenem
MDR events14All time
Recalls1All time
Registered firms7Currently listed
510(k) clearances3All time
Recent MDR events
14 adverse event reports on file
- RAPIDEC® CARBA NP (10) USOct 12, 2021MalfunctionBiomerieux Sa9615754-2021-00266
- RAPIDEC CARBA NP (10) - 415418Jul 9, 2021MalfunctionBiomerieux, Sa9615754-2021-00183
- RAPIDEC CARBA NP (10) - 415418Jul 9, 2021MalfunctionBiomerieux, Sa9615754-2021-00184
- RAPIDEC CARBA NP (10) - 415418Jul 9, 2021MalfunctionBiomerieux, Sa9615754-2021-00185
- RAPIDEC CARBA NP (10) - 415418Jul 9, 2021MalfunctionBiomerieux, Sa9615754-2021-00187
- RAPIDEC CARBA NP (10) - 415418Jul 9, 2021MalfunctionBiomerieux, Sa9615754-2021-00186
- RAPIDEC CARBA NP (10) - 415418Jul 9, 2021MalfunctionBiomerieux, Sa9615754-2021-00188
- RAPIDEC CARBA NP (10) - 415418Jul 9, 2021MalfunctionBiomerieux, Sa9615754-2021-00189
- RAPIDEC CARBA NPNov 25, 2020MalfunctionBiomerieux, Sa9615754-2020-00184
- RAPIDEC CARBA NPSep 2, 2020MalfunctionBiomérieux, Sa9615754-2020-00143
Event type breakdown
Malfunction12
Injury2
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
7 firms currently registered for this product code
510(k) clearances
3 clearances for this product code