Alinity
Alinity i Insulin Reagent Kit 200 Tests
4manufacturers in China registered for this device type
1catalogue number
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 | Abbott Medical, United States |
|---|---|
| FDA product code | CFP |
| Device type | Radioimmunoassay, Immunoreactive Insulin |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1405 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-12-04 |
| Record revised | 2021-03-30 (version 3) |
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 |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 04T7520 | In distribution |
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 Elisa Kit (Dako) | Mercodia AB | 1 |
| Insulin AccuBind Elisa Test System – 96 Wells | Monobind, Inc. | 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.