COBAS CORE PROLACTIN EIA
Device Facts
| Record ID | K930305 |
|---|---|
| Device Name | COBAS CORE PROLACTIN EIA |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | CFT · Clinical Chemistry |
| Decision Date | Aug 19, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1625 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A prolactin (lactogen) test system is a device intended to measure the anterior pituitary polypeptide hormone prolactin in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.
