Human IgG2 Subclass Kit - (for use on the Siemens BN ProSpec®)
by The Binding Site Group Ltd EUDAMED
Active
Ref NK007.P
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-05051700011952 | Date12 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- NK007.P
- Primary DI / UDI-DI
- 05051700011952
- Basic UDI-DI
- B-05051700011952
- EMDN Code
- W0102010106 Immunoglobulin g subclass reagents
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- UK-MF-000036707
- Authorised representative
- The Binding Site Ireland Limited IE-AR-000034426
Other devices from The Binding Site Group Ltd
Properties
Other properties (6)
- Sterile: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No