Product code
PTJ: Phenotypic test kit, non-susceptible/elevated mic organisms, cultured isolates
FDA product code · Class II · Microbiology
Key facts
| Product code | PTJ |
|---|---|
| Device | Phenotypic test kit, non-susceptible/elevated mic organisms, cultured isolates |
| Device class | Class II |
| Regulation number | 866.1640 |
| Review panel | Microbiology |
| Medical specialty | Microbiology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any Carbapenem |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database