Advia Centaur® Cuvettes
Laboratory analyser cuvette, IVD
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
| Zhejiang Biorear Biotechnology Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 5 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | JRI |
| Device type | Cuvette, Thermostated |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2050 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-09-24 |
| Record revised | 2021-11-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10309546 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Reaction vessel | Shenzhen Yhlo Biotech Co., Ltd. | 1 |
| Tencell™ cuvettes | The Binding Site Group Ltd. | 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.