PPM

General Purpose Reagent

Product code

PPM

Device name

General Purpose Reagent

Device class

Class 1

21 CFR

21 CFR 864.4010

Medical specialty

Pathology

Marketing pathway

510(K) Exempt

Flag

GMP exempt

510(k) clearances (all years, FDA)

16 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).