Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)

NHX · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5775

Classification

FDA Product Code: NHX
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.5775
Review panel: IM
Medical specialty: Immunology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 21
Registered establishments: 23

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown