QIAensemble Decapper System: 1 catalogue number listed by Qiagen, Gmbh, Germany, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for QIAensemble Decapper System | Listed by | Qiagen, Gmbh, Germany |
| FDA product code | JQW |
| Device type | Station, Pipetting And Diluting, For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2750 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-08-15 |
| Record revised | 2024-02-12 (version 4) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2022-11-16 |
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.