OvuSign® LH Card
OvuSign® LH card; 35 Test Kit; CE
16manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (5), Shanghai (2), Shandong (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Co-Innovation Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 29 |
| Weihai Kangzheng Medical Equipments Technology Co., Ltd. | Weihai | Shandong | Contract manufacturer | 26 |
| Abon Biopharm (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 17 |
| Abbott Diagnostics (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Dongguan Polygreen Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Computime Ltd. | Longgang Region, Shenzhan | Guangdong | Contract manufacturer | 1 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| AID United International Co., Limited | Shanghai | Shanghai | Specification developer | 65 |
| Weihai Kangzhou Biotechnology Engineering Co., Ltd. | Weihai | Shandong | Manufacturer | 24 |
| Shijiazhuang Hipro Biotechnology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 22 |
| Bioteke Corporation (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 21 |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
Showing 12 of 16. All 16 manufacturers in China registered for Radioimmunoassay, Luteinizing Hormone
Record
| Listed by | Princeton BioMeditech Corp., United States |
|---|---|
| FDA product code | CEP |
| Device type | Radioimmunoassay, Luteinizing Hormone |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1485 |
| Establishment | Manufacturer, Exporter |
| Record published | 2016-09-23 |
| Record revised | 2022-06-10 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OSH-143-35-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CVS Health | Woonsocket Prescription Center, Incorporated | 6 |
| Clearblue | SPD Swiss Precision Diagnostics Gmbh | 3 |
| Atellica IM LH | Siemens Healthcare Diagnostics Inc | 3 |
| H.E.B | H. E. Butt Grocery Company | 3 |
| Elecsys LH | Roche Diagnostics Gmbh | 3 |
| Walgreens | Walgreen Co. | 3 |
| Advia Centaur® LH | Siemens Healthcare Diagnostics Inc | 3 |
| Topcare | Topco Associates, LLC | 2 |
| Easy@Home Ovulation Test Strip (50 tests-bulk pack) | Easy Healthcare Corporation | 2 |
| Easy@Home Ovulation Test (100 LH strips) | Easy Healthcare Corporation | 2 |
| Accuhome Ovulation | Germaine Laboratories, Inc. | 2 |
| Good Neighbor Pharmacy | Amerisourcebergen Drug Corporation | 2 |
Showing 12 of 91. All products under Radioimmunoassay, Luteinizing Hormone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K963693 | 1996-11-29 |
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.