One Step FSH Urine Midstream Test
One Step FSH Urine midstream Test, EN, 2T
30manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (11), Shandong (4), Guangdong (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Weihai Kangzheng Medical Equipments Technology Co., Ltd. | Weihai | Shandong | Contract manufacturer | 26 |
| Core Technology Co., Ltd. | Changping District | Beijing | Contract manufacturer | 14 |
| Hangzhou Careomedic Tech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 5 |
| Abbott Diagnostics (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
| Hangzhou Biotest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 41 |
| W.h.p.m. Bioresearch & Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 37 |
| Guangzhou Decheng Biotechnology Co., Ltd. | Guangzhou | Guangdong | Complaint-file establishment | 35 |
Showing 12 of 30. All 30 manufacturers in China registered for Test, Follicle Stimulating Hormone (Fsh), Over The Counter
Record
| Listed by | Hangzhou AllTest Biotech Co., Ltd., China |
|---|---|
| FDA product code | NGA |
| Device type | Test, Follicle Stimulating Hormone (Fsh), Over The Counter |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1300 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-08-29 |
| Record revised | 2025-09-23 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1 | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| One Step FSH Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 3 |
| Follicle-Stimulating Hormone (FSH) Menopause test | Anhui Deepblue Medical Technology Co., Ltd. | 2 |
| HORMONElife™ | Wondfo USA Co., Ltd. | 2 |
| Semi-Quantitative Follicle-Stimulating Hormone (FSH) Test Strip | Kunming Lianen Biotechnology Co., Ltd. | 1 |
| One Step One Step FSH Urine test strip | Hangzhou AllTest Biotech Co., Ltd. | 1 |
| Pregmate | Guangzhou Decheng Biotechnology Co., Ltd. | 1 |
| One Step FSH Urine Test Strip(10 Tests) | Easy Healthcare Corporation | 1 |
| Easy@Home FSH Urine Test (5 Tests) | Easy Healthcare Corporation | 1 |
| Walgreens | Walgreen Co. | 1 |
| Rapid Response | Btnx Inc. | 1 |
| Suresign™ Menopause (FSH) Rapid Test | Guangzhou Decheng Biotechnology Co., Ltd. | 1 |
| Surearly Smart Menopause Test | Sugentech Inc._Osong Branch | 1 |
Showing 12 of 29. All products under Test, Follicle Stimulating Hormone (Fsh), Over The Counter
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.