Dimension Vista® Flex® Reagent Cartridge FSH
LOCI Follicle Stimulating Hormone Flex® reagent cartridge, 200 tests
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 | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| 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, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-09-24 |
| Record revised | 2021-11-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10488533 | 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.