QDHClass II
Menopause Test System
21 CFR 862.1093 / Clinical Chemistry
QDH is the FDA product code for Menopause Test System, a class II device type, regulated under 21 CFR 862.1093. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QDH
- Device name
- Menopause Test System
- 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.
- Regulation
- 21 CFR 862.1093
- Device class
- Class II
- Review panel
- Clinical Chemistry
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QDH
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2018 | 1 |
Applicants with the most clearances
Product code QDH| Applicant | Clearances |
|---|---|
| Ansh Labs, LLC | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.