GenaCheck®PdG At-Home Ovulation Confirmation Test
GenaCheck®PdG At-Home Ovulation Confirmation Test: 1 catalogue number listed by Genabio Diagnostics Inc, United States, under Immunoassay, Pregnanediol Glucuronide, Over The Counter. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Careomedic Tech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 5 |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
| Guangzhou Decheng Biotechnology Co., Ltd. | Guangzhou | Guangdong | Complaint-file establishment | 35 |
Record
| Listed by | Genabio Diagnostics 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, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-01-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| N/A | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Proov | MFB Fertility, Inc. | 4 |
| HORMONElife™ | Wondfo USA Co., Ltd. | 2 |
| Amazewell | Guangzhou Decheng Biotechnology Co., Ltd. | 2 |
| easy@Home PdG Urine Test Strip | Easy Healthcare Corporation | 2 |
| Wondfo | Wondfo USA Co., Ltd. | 2 |
| One Step® Progesterone (PdG) Urine Test Strip | Guangzhou Decheng Biotechnology Co., Ltd. | 1 |
| Eli Progesterone Hormometer™ | Eli Science Inc | 1 |
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.