Immage
IMMAGE Immunochemistry Systems APA Apolipoprotein A1 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 | Beckman Coulter, Inc., United States |
|---|---|
| FDA product code | MSJ |
| Device type | Apolipoproteins |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1475 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Record published | 2016-08-24 |
| Record revised | 2023-08-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 447730 | In distribution | |
| 446410 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 42 |
| Synchron | Beckman Coulter, Inc. | 2 |
| Vitros | Ortho-Clinical Diagnostics, 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.