Ue3 AccuLite Clia Test System – 96 Wells
Catalogue number 5075-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Estriol. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
Record
| Listed by | Monobind, Inc., United States |
|---|---|
| FDA product code | CGI |
| Device type | Radioimmunoassay, Estriol |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1265 |
| 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 |
|---|---|---|
| 5075-300 | Width 7.75 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AutoDELFIA Unconjugated Estriol (uE3) kit | Wallac OY | 4 |
| Free Estriol Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| uE3 AccuBind Elisa Test System – 96 Wells | Monobind, Inc. | 1 |
| Immulite®/Immulite® 1000 Systems UE3 Unconjugated Estriol | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Immulite® 2000 Systems UE3 Unconjugated Estriol | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Free Estriol Elisa | DRG International, Inc. | 1 |
| uE3 AccuLite Clia Test System – 192 Wells | Monobind, Inc. | 1 |
| AccuDiag™ Free Estriol Elisa | Diagnostic Automation, Inc. | 1 |
| Free Estriol | DRG International, Inc. | 1 |
| DBC Free Estriol Elisa | Diagnostics Biochem Canada, Inc. | 1 |
| Free Estriol | DRG Instruments Gesellschaft mit beschränkter Haftung | 1 |
| Free Estriol Elisa | American Laboratory Products Company | 1 |
Showing 12 of 14. All products under Radioimmunoassay, Estriol
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.