Progesterone AccuLite Clia Test System – 96 Wells
Catalogue number 4875-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Progesterone. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
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 | Monobind, Inc., United States |
|---|---|
| FDA product code | JLS |
| Device type | Radioimmunoassay, Progesterone |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1620 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-02-11 |
| Record revised | 2024-09-16 (version 2) |
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 |
| Storage | Storage environment temperature 2 to 8 °C |
| Sizes | Width 7.75 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4875-300 | Width 7.75 in | 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
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.