Surearly Smart Menopause Test
The Surearly SMART Menopause Test works by inserting the test stick into the Test reader, which measures color changes on the test stick. It detects FSH at a concentration of 25 mIU/mL or…
The Surearly SMART Menopause Test works by inserting the test stick into the Test reader, which measures color changes on the test stick. It detects FSH at a concentration of 25 mIU/mL or greater. The test line utilizes a monoclonal FSH antibody and the test strip contains pre-dried antibodies with gold conjugates. When urine is absorbed, FSH combines with antibody gold conjugates on the gold conjugate pad. The formed antigen-antibody complexes react with the anti-FSH antibody on the test line, resulting in red or purple lines. The control line is displayed using goat anti-rabbit IgG antibody. Instead of confusing visual interpretation, the Surearly SMART Menopause Test provides easy-to-read and clear digital results both on the device and the App. The App also provides more information with hormone graphs and additional messages to help your comprehensive management of hormonal health.
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 | Sugentech Inc._Osong Branch |
|---|---|
| FDA product code | NGA |
| Device type | Test, Follicle Stimulating Hormone (Fsh), Over The Counter |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1300 |
| Premarket notification | Exempt |
| Record published | 2025-05-15 |
| Record revised | 2026-05-07 (version 2) |
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, manufacturing date |
| Storage | Handling environment temperature 2 to 30 °C; Special storage condition: Keep away from direct sunlight, moisture and heat |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Surearly SMART Menopause Test | 10 | 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 |
| One Step FSH Urine midstream Test | Hangzhou AllTest Biotech Co., Ltd. | 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.