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.