Vitros
VITROS Chemistry Products ApoA1 Reagent
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in 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 |
Record
| Listed by | Ortho-Clinical Diagnostics, Inc., United States |
|---|---|
| FDA product code | MSJ |
| Device type | Apolipoproteins |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1475 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2020-04-18 |
| Record revised | 2023-06-21 (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 |
| Packaging | Case of 36 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6801737 | In distribution | |
| 6801738 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 42 |
| Synchron | Beckman Coulter, Inc. | 2 |
| Immage | Beckman Coulter, Inc. | 2 |
| Apolipoprotein A-I (APO A-I) | Randox Laboratories Limited | 1 |
| Antiserum to Apolipprotein B | Kent Laboratories, Inc. | 1 |
| Apolipoprotein B (APO B) | Randox Laboratories Limited | 1 |
| Apolipoprotein E (APO E) | Randox Laboratories Limited | 1 |
| Apolipoprotein C-II (APO C-II) | Randox Laboratories Limited | 1 |
| Mercodia Lp(a) Elisa | Mercodia AB | 1 |
| Atellica CH APO A1 | Siemens Healthcare Diagnostics Inc | 1 |
| Dimension Vista® Apolipoprotein AI Flex® reagent cartridge | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Advia® Chemistry APO B Reagents | Siemens Healthcare Diagnostics Inc | 1 |
Showing 12 of 18. All products under Apolipoproteins
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.