Diagnostic Kit for Pro-brain natriuretic peptide to amino-terminal (Fluorescence Immunochromatographic Assay)
by Xiamen Wiz Biotech Co., Ltd.
Ref 52350701,52350705,52350720,52350725
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-523507PA D-523507PA | Date8 Sep 2026 | 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- Withdrawn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/IVDD Active
Specification
- Device Name
- Diagnostic Kit for Pro-brain natriuretic peptide to amino-terminal (Fluorescence Immunochromatographic Assay)
- Model / Reference
- 52350701, 52350705, 52350720, 52350725
- Primary DI / UDI-DI
- D-523507PA
- Basic UDI-DI
- B-523507PA
- EMDN Code
- W0102160704 Bnp / probnp - rt & poc (including other natriuric peptides)
- Device Class
- Class IVD General
- EU market of registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CN-MF-000029590
- Authorised representative
- QbD RepS BV BE-AR-000000040
Other devices from Xiamen Wiz Biotech Co., Ltd.
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No