Immulite® 2000 Systems PRG Progesterone
Progesterone - IMMULITE - RGT - 600 Tests
4manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Hebei (1), Guangdong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 Products GmbH, Germany |
|---|---|
| FDA product code | JLS |
| Device type | Radioimmunoassay, Progesterone |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1620 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K944211 |
| Record published | 2020-09-24 |
| Record revised | 2021-11-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10381170 | In distribution | |
| 10381181 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MP Biomedicals LLC | Mp Biomedicals, LLC | 4 |
| Elecsys Progesterone III | Roche Diagnostics Gmbh | 3 |
| Alinity | Abbott Ireland | 3 |
| Architect | Abbott Ireland | 3 |
| Salimetrics | Salimetrics LLC. | 3 |
| Atellica IM Prge | Siemens Healthcare Diagnostics Inc | 3 |
| Salivary Progesterone Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 2 |
| Immulite®/Immulite® 1000 Systems PRG Progesterone | Siemens Healthcare Diagnostics Products GmbH | 2 |
| Salivary Progesterone HS Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Progesterone Luminescence Immunoassay | IBL International Gmbh | 2 |
| Progesterone Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
Showing 12 of 54. All products under Radioimmunoassay, Progesterone
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc | UDI-DI | 2019-07-10 | Class II | Under Investigation by firm | There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration for additional progesterone supplementation. | 6633 (4753 additional as of 1/13/20) | 2024-05-28 |
| Siemens Medical Solutions Diagnostics | 510(k) number | 2008-07-21 | Not classified | Other | Siemens Healthcare Diagnostics has confirmed a long-standing high bias with LKPG 1, 5. (The bias is approximately 25% at 10 – 20 ng/mL as opposed to approximately 3% at 1-3 ng/mL – for more detail see the bias plot that is included with thi | 12,908 | 2012-07-25 |
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.