BN II Additive
Washing Solution (concentrate) for cleaning the cuvettes in the BN II System
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (1), Shandong (1), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Shijiazhuang Hipro Biotechnology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 22 |
| Genrui Biotech Inc | Shenzhen | Guangdong | Manufacturer | 4 |
Record
| Listed by | Siemens Healthcare Diagnostics Products GmbH, Germany |
|---|---|
| FDA product code | JZW |
| Device type | Nephelometer |
| Device class | Class 1 |
| Regulation | 21 CFR 866.4540 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K001647 |
| Record published | 2020-09-24 |
| Record revised | 2023-06-02 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10446098 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cleaner SCS | Siemens Healthcare Diagnostics Products GmbH | 1 |
| N Evaporation Caps for Reagent Vials (5 ml) | Siemens Healthcare Diagnostics Products GmbH | 1 |
| N Cuvette Segments for BN ProSpec® | Siemens Healthcare Diagnostics Products GmbH | 1 |
| N Evaporation Caps for Control Vials (2.5 mL) | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 1 |
| BN ProSpec® System | Siemens Healthcare Diagnostics Products GmbH | 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 | Closed |
|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2019-06-27 | Class II | Process change control | Iincreased (falsely elevated) Albumin results compared to expected results | 664 units | 2020-05-27 |
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.