# Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody
> **Product code: 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
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NYO)
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