# Autoantibodies, Nuclear Body Protein, Sp100
> **Product code: NUM** · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5090
## Classification
- **FDA Product Code:** NUM
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.5090
- **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, IN HUMAN SERUM OR PLASMA, OF AUTOANTIBODIES TO SP100 (NUCLEAR BODY PROTEIN SP100) AS AN AID IN THE DIAGNOSIS OF PRIMARY BILIARY CIRRHOSIS.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 5
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NUM)
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