Insulin
The DRG:HYBRId-XL Insulin is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Insulin in serum and plasma (EDTA and Heparin).
4manufacturers in China registered for this device type
1catalogue number
1recall
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 | DRG International, Inc., United States |
|---|---|
| FDA product code | CFP |
| Device type | Radioimmunoassay, Immunoreactive Insulin |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1405 |
| Establishment | Repacker / relabeller, Complaint-file establishment |
| Premarket notification | Exempt |
| Record published | 2023-08-26 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HYE-5361 | 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
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-10-07 | Class II | Nonconforming Material/Component | The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument using the re-calibration R1 and R2 of the device or find controls out of specification (failed Control High) which causes a delay in r | 10 units |
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.