Product code
PPM: General purpose reagent
FDA product code · Class I · Pathology
Key facts
| Product code | PPM |
|---|---|
| Device | General purpose reagent |
| Device class | Class I |
| Regulation number | 864.4010 |
| Review panel | Pathology |
| Medical specialty | Pathology |
| Submission type | 510(K) Exempt |
| GMP exempt | Yes |
| Definition | A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in… |
At a glance
- 10–99 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1,000+ UDI devices (GUDID)
- 100–999 MAUDE adverse event reports
- 10–99 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