FDA product code NHX

Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)

Immunology·Class 2·21 CFR 866.5775
US regulatory classifications
US Product Code (FDA)
NHX
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.5775
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Medical specialty
Immunology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
Definition

The device is used for the detection of anti-cyclic citrullinated peptide (CCP) antibodies in human serum or plasma as an aid in the diagnosis of rheumatoid arthritis.

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About this record

Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) is a medical device type in the Immunology 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.