A comprehensive screening kit that analyzes key hormone factors related to fertility. Contains 3 FSH urine tests to check ovarian reserve, 10 LH tests to predict ovulation during the…
A comprehensive screening kit that analyzes key hormone factors related to fertility. Contains 3 FSH urine tests to check ovarian reserve, 10 LH tests to predict ovulation during the fertile window, and 5 PdG tests to confirm ovulation during the implantation window.
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Proov | Listed by | MFB Fertility, Inc., United States |
| FDA product code | QKE |
| Device type | Immunoassay, Pregnanediol Glucuronide, Over The Counter |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1620 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K191462 |
| Record published | 2023-03-24 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.