Insulin Elisa Kit (Dako)
Insulin ELISA Kit provides a method for the quantitative determination of human insulin in serum or plasma. As with all diagnostic tests, a definitve clinical diagnosis should not be based…
Insulin ELISA Kit provides a method for the quantitative determination of human insulin in serum or plasma. As with all diagnostic tests, a definitve clinical diagnosis should not be based on the results of a single test, but should be made by the physician after all clinical findings have been evaluated. The analysis should be performed by trained laboratory professionals.
Who Else Makes It
Concentrated in Jilin (1), Guangdong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| 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 | Mercodia AB, Sweden |
|---|---|
| FDA product code | CFP |
| Device type | Radioimmunoassay, Immunoreactive Insulin |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1405 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-04-08 |
| Record revised | 2024-10-01 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Distribution end date | 2024-05-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K2379 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Salimetrics | Salimetrics LLC. | 2 |
| Elecsys Insulin | Roche Diagnostics Gmbh | 2 |
| Insulin | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Insulin Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Immulite® 2000 Systems INS Insulin | Siemens Healthcare Diagnostics Products GmbH | 2 |
| Atellica IM IRI DIL | Siemens Healthcare Diagnostics Inc | 2 |
| Advia Centaur® IRI | Siemens Healthcare Diagnostics Inc | 2 |
| Anti-Insulin Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Atellica IM IRI | Siemens Healthcare Diagnostics Inc | 2 |
| Architect | Abbott Medical | 1 |
| Insulin AccuBind Elisa Test System – 96 Wells | Monobind, Inc. | 1 |
| Mercodia Ultrasensitive Insulin Elisa | Mercodia AB | 1 |
Showing 12 of 48. All products under Radioimmunoassay, Immunoreactive Insulin
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.