Surearly Smart Ovulation Test
The Surearly SMART Ovulation Test works by inserting the test stick into the test reader, which measures color changes on the test stick. It detects LH (10 mIU/mL or greater) and…
The Surearly SMART Ovulation Test works by inserting the test stick into the test reader, which measures color changes on the test stick. It detects LH (10 mIU/mL or greater) and Progesterone metabolites (5 ug/mL or greater) in urine. Monoclonal LH antibodies and P3G-BSA conjugate with anti-P3G antibodies are immobilized on test lines 1 and 2 respectively. The test strip contains pre-dried antibodies with gold conjugates. When urine is absorbed, LH and P3G combine with antibody gold conjugates on the gold conjugate pad. The antigen-antibody complexes react with anti-LH antibody on test line 1 and P3G-BSA on test line 2, forming red or purple lines. The control line is displayed using goat anti-rabbit IgG antibody. Instead of confusing visual interpretation, Surearly SMART Ovulation Test provides easy-to-read and clear digital results both on the device and the App. The App also provides more information with hormone graph and additional messages to help your comprehensive management of hormone cycle.
Who Else Makes It
Concentrated in Zhejiang (14), Jiangsu (4), Guangdong (4). 8 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 |
| Hangzhou Biotest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 41 |
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| 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 |
| Baoding Abiores Chip Co., Ltd. | Baoding | Hebei | Contract manufacturer | 1 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Planet(Shanghai) International Co., Ltd. | Shanghai | Shanghai | Exporter | 93 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
Showing 12 of 38. All 38 manufacturers in China registered for Test, Luteinizing Hormone (Lh), Over The Counter
Record
| Listed by | Sugentech Inc._Osong Branch |
|---|---|
| FDA product code | NGE |
| Device type | Test, Luteinizing Hormone (Lh), Over The Counter |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1485 |
| 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 Ovulation Test | 10 | In distribution | |
| Surearly SMART Ovulation Test | 20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Clearblue | SPD Swiss Precision Diagnostics Gmbh | 19 |
| Ferticare | Weihai Kangzhou Biotechnology Engineering Co., Ltd. | 9 |
| Wondfo | Wondfo USA Co., Ltd. | 7 |
| One Step® LH Ovulation Rapid Test Dipstick (Urine) | Guangzhou Decheng Biotechnology Co., Ltd. | 6 |
| Amazewell | Guangzhou Decheng Biotechnology Co., Ltd. | 5 |
| iProvèn | Masena Invest B.V. | 5 |
| Firstview Luteinizing Hormone Rapid Test Strip | Safecare Biotech(Hangzhou)Co., Ltd. | 4 |
| Macro & Micro-Test LH Test | Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | 4 |
| Egens | Nantong Egens Biology Technic Co., Ltd. | 4 |
| MissLan | Guangzhou Decheng Biotechnology Co., Ltd. | 4 |
| VeriQuick | Fourstar Group | 3 |
| Modern Fertility Ovulation Test | Modern Healthcare Corp. | 3 |
Showing 12 of 69. All products under Test, Luteinizing Hormone (Lh), 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.