Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations
- US Product Code (FDA)
- QHMView Product Code Classification →
- US Risk Class (FDA)
- Class U
- US Regulation (CFR)
- 21 CFR 610.40View CFR Regulation →
- Medical specialty
- Microbiology
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
For the qualitative detection of antibodies or antigens to infectious disease agents in human specimens
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Serology 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.