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General Purpose Reagent

FDA product code PPM · 16 cleared devices

Class 1 Pathology
Regulation
21 CFR 864.4010
Review panel
PA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
Yes
Clearance span
1981-07-28 – 1987-04-29

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.

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