Biobase
Catalogue number BK-SPA120, listed by Biobase Biodustry(Shandong)Co., Ltd., China, under Nephelometer. 4 manufacturers in China are registered for this product code.
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 | Biobase Biodustry(Shandong)Co., Ltd., China |
|---|---|
| FDA product code | JZW |
| Device type | Nephelometer |
| Device class | Class 1 |
| Regulation | 21 CFR 866.4540 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-07-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BK-SPA120 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BN II Additive | Siemens Healthcare Diagnostics Products GmbH | 1 |
| 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 |
| BN ProSpec® System | Siemens Healthcare Diagnostics Products GmbH | 1 |
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.