Lumipulse G Prolactin Immunoreaction Cartridges
Catalogue number 235195, listed by Fujirebio Inc., Japan, under Radioimmunoassay, Prolactin (Lactogen). 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
1catalogue number
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 | Fujirebio Inc., Japan |
|---|---|
| FDA product code | CFT |
| Device type | Radioimmunoassay, Prolactin (Lactogen) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1625 |
| Establishment | Manufacturer |
| Record published | 2017-10-18 |
| Record revised | 2024-10-10 (version 5) |
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 |
| Storage | Special storage condition: Right side up with care; no vibration; Storage environment temperature 2 to 10 °C; Handling environment temperature 2 to 10 °C |
| Distribution end date | 2023-01-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 235195 | Size Type = Tests per Kit; Size Unit = 42; Unit of Measure = Tests | Withdrawn |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 |
| 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)
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.