Access Prolactin
The Access Prolactin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of prolactin (PRL) levels in human serum and plasma (heparin) using…
The Access Prolactin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of prolactin (PRL) levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
Who Else Makes It
Concentrated in Jilin (1), Shandong (1), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Shijiazhuang Hipro Biotechnology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 22 |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
| Beijing Hotgen Biotech Co., Ltd. | Beijing | Beijing | Manufacturer | 13 |
Record
| Listed by | Beckman Coulter, Inc., United States |
|---|---|
| FDA product code | CFT |
| Device type | Radioimmunoassay, Prolactin (Lactogen) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1625 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-09-03 |
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 |
|---|---|---|
| 33530 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Elecsys Prolactin II | Roche Diagnostics Gmbh | 3 |
| Atellica IM PRL | Siemens Healthcare Diagnostics Inc | 3 |
| Advia Centaur® PRL | Siemens Healthcare Diagnostics Inc | 2 |
| Architect | Abbott Ireland | 2 |
| Prolactin Elisa | DRG International, Inc. | 2 |
| Alinity | Abbott Ireland | 2 |
| Immulite® 2000 Systems PRL Prolactin | Siemens Healthcare Diagnostics Products GmbH | 2 |
| Prolactin | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 2 |
| Prolactin Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Monobind AccuBind PRL Elisa Kit – 96 Wells | Monobind, Inc. | 1 |
| Immulite® 2000 Systems PRL Prolactin Sample Diluent | Siemens Healthcare Diagnostics Products GmbH | 1 |
Showing 12 of 40. All products under Radioimmunoassay, Prolactin (Lactogen)
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-08-03 | Not classified | Equipment maintenance | The recall was initiated because Beckman Coulter has confirmed that the Active Prolactin ElLISA kit, lot number 890291 over estimates the expected dose values for patient serum samples due to a shift in the assigned calibrator values. Beck | 30 Kits | 2012-04-27 |
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.