Elecsys Insulin
2 catalogue numbers from 12017547122, listed by Roche Diagnostics Gmbh, Germany, under Radioimmunoassay, Immunoreactive Insulin. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Roche Diagnostics Gmbh, Germany |
|---|---|
| FDA product code | CFP |
| Device type | Radioimmunoassay, Immunoreactive Insulin |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1405 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-05-14 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12017547122 | In distribution | |
| 07027559190 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Salimetrics | Salimetrics LLC. | 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 Elisa Kit (Dako) | Mercodia AB | 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.