APO B
An APO B test system is a device intended for the quantitative in vitro determination of Apolipoprotein B (APO B) in serum and plasma.
1manufacturer
4catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Randox Laboratories Limited, United Kingdom |
|---|---|
| FDA product code | JHN |
| Device type | Turbidimetric Method, Lipoproteins |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1475 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K950383 |
| Record published | 2016-09-26 |
| 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 |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LP3839 | In distribution | |
| LP2867 | In distribution | |
| LP2990 | In distribution | |
| LP2117 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| APO A-I | Randox Laboratories Limited | 4 |
| AU | Beckman Coulter, Inc. | 3 |
| 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 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K950382 | 1995-09-15 |
| K950383 | 1995-09-15 |
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.