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FDA 21

21 CFR Part 809

In Vitro Diagnostic Products for Human Use
United StatesFDALabeling
What this code is

21 CFR Part 809 is the official FDA identifier for “In Vitro Diagnostic Products for Human Use”. 21 CFR Part 809 is the official identifier FDA uses for this instrument.

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21 CFR Part 809
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7 articles · 1 language version
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About this regulation

In Vitro Diagnostic Products for Human Use

Current eCFR Part 809 in vitro diagnostic product requirements.

21 CFR Part 809 is the official identifier FDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.