FDA product code MIU
Enzyme Linked Immunosorbent Assay, T. Cruzi
Microbiology·Class 1·21 CFR 866.3870
US regulatory classifications
- US Product Code (FDA)
- MIUView Product Code Classification →
- US Risk Class (FDA)
- Class 1
- US Regulation (CFR)
- 21 CFR 866.3870View CFR Regulation →
- Medical specialty
- Microbiology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Eligible
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About this record
Enzyme Linked Immunosorbent Assay, T. Cruzi 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.