FDA product code GTX
Antisera, Fluorescent, All Groups, Streptococcus Spp.
Microbiology·Class 1·21 CFR 866.3740
US regulatory classifications
- US Product Code (FDA)
- GTXView Product Code Classification →
- US Risk Class (FDA)
- Class 1
- US Regulation (CFR)
- 21 CFR 866.3740View CFR Regulation →
- Medical specialty
- Microbiology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
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About this record
Antisera, Fluorescent, All Groups, Streptococcus Spp. 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.