Access hLH
The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the…
The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems.
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 | Beckman Coulter, Inc., United States |
|---|---|
| FDA product code | CEP |
| Device type | Radioimmunoassay, Luteinizing Hormone |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1485 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-04-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 33510 | 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
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-11-05 | Class II | Nonconforming Material/Component | Beckman Coulter Inc. (BEC) has demonstrated that real time stability testing of hLH Calibrator of certain lots have failed the 13-month and 14-month time points. Per BEC’s real time stability procedure, in order to verify expiration dating | 14409 | 2014-05-14 |
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.