SR1 DHEA-S ENZYME IMMUNOASSAY
Device Facts
| Record ID | K942051 |
|---|---|
| Device Name | SR1 DHEA-S ENZYME IMMUNOASSAY |
| Applicant | Serono Diagnostics, Inc. |
| Product Code | JKC · Clinical Chemistry |
| Decision Date | Jul 13, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1245 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A dehydroepiandrosterone (free and sulfate) test system is a device intended to measure dehydroepiandrosterone (DHEA) and its sulfate in urine, serum, plasma, and amniotic fluid. Dehydroepiandrosterone measurements are used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.
