Free Estriol Elisa
The DRG Free Estriol ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free estriol (unconjugated estriol) in serum during the second half of pregnancy.
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
Record
| Listed by | DRG Instruments Gesellschaft mit beschränkter Haftung |
|---|---|
| FDA product code | CGI |
| Device type | Radioimmunoassay, Estriol |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1265 |
| Premarket notification | Exempt |
| Record published | 2024-11-22 |
| Record revised | 2024-11-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| 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 |
| Distribution end date | 2024-11-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EIA-1612 | In distribution | |
| EIA-1612 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AutoDELFIA Unconjugated Estriol (uE3) kit | Wallac OY | 4 |
| 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 |
| Free Estriol Elisa | Euroimmun Medizinische Labordiagnostika AG | 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.