FDA product code QHO

Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations

Microbiology·Class U·21 CFR 610.40
US regulatory classifications
US Product Code (FDA)
QHO
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US Risk Class (FDA)
Class U
US Regulation (CFR)
21 CFR 610.40
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Medical specialty
Microbiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

For the qualitative detection of nucleic acid for infectious disease agents in human specimens.

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Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.