GESTE FOLLOW KIT DETERM. OF HPL
Device Facts
| Record ID | K802454 |
|---|---|
| Device Name | GESTE FOLLOW KIT DETERM. OF HPL |
| Applicant | Syn-Kit, Inc. |
| Product Code | JMF · Clinical Chemistry |
| Decision Date | Nov 12, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1585 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A human placental lactogen test system is a device intended to measure the hormone human placental lactogen (HPL), (also known as human chorionic somatomammotrophin (HCS)), in maternal serum and maternal plasma. Measurements of human placental lactogen are used in the diagnosis and clinical management of high-risk pregnancies involving fetal distress associated with placental insufficiency. Measurements of HPL are also used in pregnancies complicated by hypertension, proteinuria, edema, post-maturity, placental insufficiency, or possible miscarriage.
