VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075)
Device Facts
| Record ID | K970894 |
|---|---|
| Device Name | VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075) |
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc. |
| Product Code | DHA · Clinical Chemistry |
| Decision Date | Apr 14, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1155 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.
