Prealbumin RID Plate Kit
Radial immunodiffusion plate package for Human Prealbumin with standards
3manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jilin (1), Shandong (1), Hebei (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 |
| Shijiazhuang Hipro Biotechnology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 22 |
Record
| Listed by | Kent Laboratories, Inc., United States |
|---|---|
| FDA product code | JZJ |
| Device type | Prealbumin, Antigen, Antiserum, Control |
| Device class | Class 1 |
| Regulation | 21 CFR 866.5060 |
| Establishment | Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 8 |
| Architect | Abbott Laboratories | 2 |
| Prealbumin | Roche Diagnostics Gmbh | 2 |
| Antiserum to Human Prealbumin | Kent Laboratories, Inc. | 1 |
| K-Assay® Prealbumin Calibrator | Kamiya Biomedical Company LLC | 1 |
| Atellica CH Prealbumin (Palb) | Siemens Healthcare Diagnostics Inc | 1 |
| Alinity | Abbott Medical | 1 |
| DImension Vista® Prealbumin Flex® reagent cartridge | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Yumizen C1200 Prealbumin | Horiba ABX SAS | 1 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 1 |
| Human Prealbumin Kit for use on Spaplus | The Binding Site Group Ltd. | 1 |
| N Antiserum to Human Prealbumin | Siemens Healthcare Diagnostics Products GmbH | 1 |
Showing 12 of 24. All products under Prealbumin, Antigen, Antiserum, Control
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K951966 | 1995-06-01 |
| K850686 | 1985-11-01 |
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.