C-Peptide AccuLite Clia Test System – 96 Wells
Catalogue number 2775-300, listed by Monobind, Inc., United States, under Radioimmunoassay, C-Peptides Of Proinsulin. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
1catalogue number
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 | Monobind, Inc., 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, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-02-11 |
| Record revised | 2024-09-16 (version 2) |
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, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C |
| Sizes | Width 7.75 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2775-300 | Width 7.75 in | In distribution |
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 |
| Architect | Abbott Laboratories | 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 |
Showing 12 of 37. All products under Radioimmunoassay, C-Peptides Of Proinsulin
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.