Proov
At home IVD LH tests (also called ovulation tests or OPKs) measure luteinizing hormone before ovulation to identify your two most fertile days.
38manufacturers in China registered for this device type
1catalogue number
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 | MFB Fertility, Inc., United States |
|---|---|
| FDA product code | NGE |
| Device type | Test, Luteinizing Hormone (Lh), Over The Counter |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1485 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-04-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Predict | 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.