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Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)

FDA product code NHX · 20 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.5775
Review panel
IM
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2002-04-29 – 2016-08-04

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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