Access Progesterone II
The Access Progesterone II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of progesterone levels in human serum and plasma (lithium…
The Access Progesterone II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of progesterone levels in human serum and plasma (lithium heparin) using the automated Access 2 Immunoassay System and DxI 9000 Access Immunoassay Analyzer. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.
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 | Beckman Coulter, Inc., United States |
|---|---|
| FDA product code | JLS |
| Device type | Radioimmunoassay, Progesterone |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1620 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-03-01 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C78020 | 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
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-02-17 | Not classified | Other | The recall was initiated by Beckman Coulter after the firm confirmed customer reports that the affected lot of Access Cortisol reagent (REF 33600) identified above may produce suppressed patient results. Beckman Coulter also confirmed custo | 6412 | 2012-04-19 |
| 2002-12-06 | Not classified | Other | Primary tube sampling issue may cause false low results. | 6,655 | 2003-07-26 |
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.