AIA-Pack IRI Calibrator SET
AIA-Pack IRI Calibrator SET: 1 catalogue number listed by Tosoh Corp., Japan, under Radioimmunoassay, Immunoreactive Insulin. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Tosoh Corp., Japan |
|---|---|
| FDA product code | CFP |
| Device type | Radioimmunoassay, Immunoreactive Insulin |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1405 |
| Establishment | Exporter |
| Premarket notification | Exempt |
| Record published | 2019-07-24 |
| Record revised | 2024-04-01 (version 3) |
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 |
| Packaging | Pack of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N/A | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K903628 | 1990-09-07 |
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.