CVS Health
A convenience kit consisting of 10 Ovulation Test devices and 1 One-Step Pregnancy Test
16manufacturers in China registered for this device type
6catalogue numbers in this listing
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 | Woonsocket Prescription Center, Incorporated |
|---|---|
| FDA product code | CEP |
| Device type | Radioimmunoassay, Luteinizing Hormone |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1485 |
| 510(k) | K042280 |
| Record published | 2019-06-07 |
| Record revised | 2023-11-23 (version 3) |
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 |
| Storage | Storage environment temperature 2 to 30 °C |
| Packaging | Shipping case of 48, shipping case of 24 |
| Distribution end date | 2023-11-07 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| One Step Ovulation Test | 7 | In distribution | |
| Ovulation Test Kit | In distribution | ||
| Early Ovulation Test Kit | In distribution | ||
| Daily Ovulation Test Strips | 20 | Withdrawn | |
| One Step Ovulation Predictor | 7 | Withdrawn | |
| Daily Ovulation Predictor | 20 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Kroger | Kroger Co., THE | 2 |
Showing 12 of 91. All products under Radioimmunoassay, Luteinizing Hormone
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.