Architect
ARCHITECT C-Peptide Reagent Kit
6manufacturers in China registered for this device type
1catalogue number
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (2), Jilin (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| 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 |
| Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
Record
| Listed by | Abbott Laboratories, United States |
|---|---|
| FDA product code | JKD |
| Device type | Radioimmunoassay, C-Peptides Of Proinsulin |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1135 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-06-06 |
| Record revised | 2023-11-17 (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 |
| Distribution end date | 2020-12-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3L53-25 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Atellica IM CpS | Siemens Healthcare Diagnostics Inc | 2 |
| C-Peptide & Insulin Diabetes Panel AccuLite Vast Clia Test System – 96 Wells | Monobind, Inc. | 2 |
| Elecsys C-Peptide | Roche Diagnostics Gmbh | 2 |
| C-Peptide Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Alpco C-peptide Elisa Jumbo | American Laboratory Products Company | 1 |
| Stellux® Chemi Human Total Proinsulin Elisa | American Laboratory Products Company | 1 |
| Mercodia Ultrasensitive C-peptide Elisa | Mercodia AB | 1 |
| Monobind AccuBind C-Peptide Elisa Kit – 192 Wells | Monobind, Inc. | 1 |
| Immulite® 2000 Systems C-Peptide | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Monobind AccuBind C-Peptide & Insulin Vast Elisa Kit – 192 Wells | Monobind, Inc. | 1 |
| Stellux® Chemi Human C-peptide Elisa Lab Pack | American Laboratory Products Company | 1 |
| ST AIA-Pack C-Peptide II | Tosoh Corp. | 1 |
Showing 12 of 37. All products under Radioimmunoassay, C-Peptides Of Proinsulin
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-04-01 | Class III | Employee error | Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a new license is obtained. | 65 kits total | 2020-09-01 |
| 2011-07-11 | Not classified | Nonconforming Material/Component | C-Peptide lots 03610K000 and 01711A000 have the potential to generate falsely elevated results with certain patient samples and with non-Abbott Controls. | 3,049 kits | 2012-02-10 |
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.