QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA
Device Facts
| Record ID | DEN000007 |
|---|---|
| Device Name | QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA |
| Applicant | Inova Diagnostics, Inc. |
| Product Code | NBT · Immunology |
| Decision Date | Aug 16, 2000 |
| Decision | DENG |
| Submission Type | Post-NSE |
| Regulation | 21 CFR 866.5785 |
| Device Class | Class 2 |
Regulatory Classification
Identification
The Anti-Saccharomyces cerevisiae (S. cerevisiae ) antibody (ASCA) test system is an in vitro diagnostic device that consists of the reagents used to measure, by immunochemical techniques, antibodies to S. cerevisiae (baker's or brewer's yeast) in human serum or plasma. Detection of S. cerevisiae antibodies may aid in the diagnosis of Crohn's disease.
Special Controls
*Classification.* Class II (special controls). The special control is FDA's “Guidance for Industry and FDA Reviewers: Class II Special Control Guidance Document for Anti-*Saccharomyces cerevisiae* (*S. cerevisiae* ) Antibody (ASCA) Premarket Notifications.”
