VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS
Device Facts
| Record ID | K970281 |
|---|---|
| Device Name | VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS |
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc. |
| Product Code | CFT · Clinical Chemistry |
| Decision Date | Feb 25, 1997 |
| 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.
