Plasma/Serum Cell-Free Circulating Purification Kit Dx
by Norgen Biotek Corporation 4 variants
Ref Dx55100
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number++G226PlaSercfcDNAPKitXA ++G226DX551000_ | Date4 Nov 2024 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Plasma/Serum Cell-Free Circulating Purification Kit Dx
- Model / Reference
- Dx55100
- Primary DI / UDI-DI
- ++G226DX551000_
- Basic UDI-DI
- ++G226PlaSercfcDNAPKitXA
- Direct Marketing DI
- ++G226DX551000_
- EMDN Code
- W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
- Device Class
- Class A
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CA-MF-000024034
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
From the manufacturer
Manufacturer's product page: RNA
Other devices from Norgen Biotek Corporation
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No