OVEIA (TM) DUAL ANALYTE
Device Facts
| Record ID | K872843 |
|---|---|
| Device Name | OVEIA (TM) DUAL ANALYTE |
| Applicant | Boots-Celltech Diagnostics, Inc. |
| Product Code | JLP · Clinical Chemistry |
| Decision Date | Feb 2, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1605 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A pregnanediol test system is a device intended to measure pregnanediol (a major urinary metabolic product of progesterone) in urine. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.
