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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device general purpose reagent
Regulation Description General purpose reagent.
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.
Product CodePPM
Regulation Number 864.4010
Device Class 1

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