One Step® Progesterone (PdG) Urine Test Strip
PdG strip pack of 6
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 | Guangzhou Decheng Biotechnology Co., Ltd., China |
|---|---|
| FDA product code | QKE |
| Device type | Immunoassay, Pregnanediol Glucuronide, Over The Counter |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1620 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2026-03-31 |
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 |
|---|---|---|---|
| 6T | 6 | 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 |
| GenaCheck®PdG At-Home Ovulation Confirmation Test | Genabio Diagnostics Inc | 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.