Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody

NYO · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5100

Classification

FDA Product Code: NYO
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.5100
Review panel: IM
Medical specialty: Immunology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

The anti-rna polymerase iii test is a semi-quantitative elisa for the detection of anti-rna polymerase iii antibodies in human serum. The test result is used as an aid in the diagnosis of systemic sclerosis (ssc) in conjunction with the clinical and other laboratory findings. For in-vitro diagnostic use.

Market data

Cleared 510(k) submissions: 4
Registered establishments: 6

Source

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