Atellica IM PRL
Prolactin (PRL) - Atellica IM - RGT 250
6manufacturers in China registered for this device type
3catalogue numbers in this listing
2recalls on this code
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 | Siemens Healthcare Diagnostics 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, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-09-24 |
| Record revised | 2021-11-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store Upright, Protect from Light, Do not freeze, Resuspend.; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10995656 | In distribution | ||
| 10995655 | 5 | In distribution | |
| 11206258 | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Elecsys Prolactin II | Roche Diagnostics Gmbh | 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 |
| Vidas® Prolactin | bioMerieux, Inc. | 1 |
Showing 12 of 40. All products under Radioimmunoassay, Prolactin (Lactogen)
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-03-21 | Class II | Under Investigation by firm | The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, a | 3,443 units | 2018-08-03 |
| 2012-08-07 | Class III | Nonconforming Material/Component | ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40 | 15, 455 kits | 2014-02-26 |
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.