AU
APO A1 & B Calibrator
1manufacturer
3catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
Record
| Listed by | Beckman Coulter, Inc., United States |
|---|---|
| FDA product code | JHN |
| Device type | Turbidimetric Method, Lipoproteins |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1475 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| 510(k) | K952425 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-06 (version 3) |
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 |
|---|---|---|
| OSR6142 | In distribution | |
| ODR3022 | In distribution | |
| OSR6143 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| APO A-I | Randox Laboratories Limited | 4 |
| APO B | Randox Laboratories Limited | 4 |
| Human Apolipoprotein A-1 (Apo A-1) kit for use on Spaplus | The Binding Site Group Ltd. | 1 |
| Human Apolipoprotein B (Apo B) kit for use on Spaplus | The Binding Site Group Ltd. | 1 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Beckman Coulter Ireland Inc | 510(k) number | 2025-04-23 | Class III | Error in labeling | The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for | 2747 units |
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.