Prolactin Elisa
The Prolactin ELISA is intended for the quantitative determination of prolactin in human serum. The assay is useful in the diagnosis and treatment of disorders of the anterior pituitary and…
The Prolactin ELISA is intended for the quantitative determination of prolactin in human serum. The assay is useful in the diagnosis and treatment of disorders of the anterior pituitary and hypothalamus.
6manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | DRG International, Inc., United States |
|---|---|
| FDA product code | CFT |
| Device type | Radioimmunoassay, Prolactin (Lactogen) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1625 |
| Establishment | Repacker / relabeller, Complaint-file establishment |
| Premarket notification | Exempt |
| Record published | 2021-06-07 |
| Record revised | 2023-07-26 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C |
| Distribution end date | 2022-08-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EIA-1291 | In distribution | |
| EIA-1786 | Withdrawn |
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 |
| 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 |
| Vidas® Prolactin | bioMerieux, Inc. | 1 |
Showing 12 of 40. All products under Radioimmunoassay, Prolactin (Lactogen)
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.