FDA product code OSL
Control, Fecal Occult Blood
Hematology·Class 2·21 CFR 864.6550
US regulatory classifications
- US Product Code (FDA)
- OSLView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 864.6550View CFR Regulation →
- Medical specialty
- Hematology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
Fecal occult blood controls (Negative and positive) are used to verify the performance of the fecal occult blood test devices.
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About this record
Control, Fecal Occult Blood is a medical device type in the Hematology 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.