Optilite Prealbumin Kit
Catalogue number NK066.OPT.A, listed by The Binding Site Group Ltd., United Kingdom, under Prealbumin, Antigen, Antiserum, Control. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | The Binding Site Group Ltd., United Kingdom |
|---|---|
| FDA product code | JZJ |
| Device type | Prealbumin, Antigen, Antiserum, Control |
| Device class | Class 1 |
| Regulation | 21 CFR 866.5060 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (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 |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NK066.OPT.A | 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 |
|---|---|
| K913672 | 1991-12-20 |
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.