SAA/hs-CRP+conventional CRP Combo Test Kit (Immunofluorescence Method)
by Wuhan Easydiagnosis Biomedicine Co., Ltd. 2 variants
Ref W-IF2-SAA-CRP-20Model 20 tests/kit
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-06978896416042 06978896416042 | Date22 Apr 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- Withdrawn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
- SAA/hs-CRP+conventional CRP Combo Test Kit (Immunofluorescence Method)
- Model / Reference
- 20 tests/kit, W-IF2-SAA-CRP-20
- Primary DI / UDI-DI
- 06978896416042
- Basic UDI-DI
- B-06978896416042
- EMDN Code
- W01021499 Multiple immunochemistry reagents - other
- Device Class
- Class IVD General
- EU market of registration
- Romania
Manufacturer details
- EUDAMED SRN
- CN-MF-000019908
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
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Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No