QDH
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Menopause Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1093
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
- FDA definition
- A menopause test system is an in vitro diagnostic device intended to measure hormones or other analytes in human clinical specimens as an aid in the determination of menopausal status in women.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| picoAMH ELISA (DEN180004) | Ansh Labs, LLC | 2018-10-24 |
Track QDH automatically
Every clearance here is in the API, with alerts when new ones post.