Accuhome Ovulation
Urine Midstream. Rapid qualitative test to detect the LH surge in urine. Designed to aid in the prediction of ovulation, for self testing (home).
16manufacturers in China registered for this device type
2catalogue 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 | Germaine Laboratories, Inc., United States |
|---|---|
| FDA product code | CEP |
| Device type | Radioimmunoassay, Luteinizing Hormone |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1485 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-04-27 |
| Record revised | 2022-06-10 (version 3) |
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 |
|---|---|---|---|
| 75501 | In distribution | ||
| 75540 | 40 | 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 |
| 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.