MGC Health
MGC HEALTH™ OVULATION RAPID TEST, 20T/Box
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 | Guangzhou Decheng Biotechnology Co., Ltd., China |
|---|---|
| FDA product code | NGE |
| Device type | Test, Luteinizing Hormone (Lh), Over The Counter |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1485 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-09-27 |
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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 20T | 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.