BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT
Device Facts
| Record ID | K954065 |
|---|---|
| Device Name | BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT |
| Applicant | Biochem Immunosystems (U.S.), Inc. |
| Product Code | JHI · Clinical Chemistry |
| Decision Date | Jul 10, 1996 |
| 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.
