Definition: Qualitative Detection Of Carbapenemase Enzymes In Pure Colonies Of Enterobacteriaceae And Pseudomonas Aeruginosa That Have Elevated MIC Values To Any Carbapenem
| Device Type ID | 3581 |
| Device Name | Phenotypic Test Kit, Non-susceptible/elevated Mic Organisms, Cultured Isolates |
| Physical State | Single Use, Disposable |
| Technical Method | Biochemical Hydrolysis |
| Target Area | Not Applicable |
| Regulation Description | Antimicrobial Susceptibility Test Powder. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.1640 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PTJ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3581 |
| Device | Phenotypic Test Kit, Non-susceptible/elevated Mic Organisms, Cultured Isolates |
| Product Code | PTJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Antimicrobial Susceptibility Test Powder. |
| CFR Regulation Number | 866.1640 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOMERIEUX SA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
False Negative Result | 4 |
| Total Device Problems | 4 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biomerieux Inc | II | Jun-27-2017 |