# General Purpose Reagent
> **Product code: PPM** · Class I — Low Risk (general controls) · Pathology · 21 CFR 864.4010
## Classification
- **FDA Product Code:** PPM
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 864.4010
- **Review panel:** PA
- **Medical specialty:** Pathology
- **Submission type:** 4
- **GMP exempt:** Y
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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 conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test.

## Market data
- **Cleared 510(k) submissions:** 16
- **Registered establishments:** 256
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PPM)
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