HSV-1/2 IgM Antibody Chemiluminescent Immunoassay Kit
by Maccura Biotechnology Co., Ltd.
Ref IM4415126, EIM4201327, IM4410126, IM4414126, IM4411126, EIM4202332, EIM4201332
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-IM4415126JM | Date22 May 2022 | 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- Withdrawn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
- HSV-1/2 IgM Antibody Chemiluminescent Immunoassay KitHSV-1/2 IgM
- Model / Reference
- IM4415126, EIM4201327, IM4410126, IM4414126, IM4411126, EIM4202332, EIM4201332
- Primary DI / UDI-DI
- D-IM4415126JM, D-EIM4201327EY, D-IM4410126HJ, D-IM4414126JE, D-IM4411126HR, D-EIM4202332EY, D-EIM4201332ER
- Basic UDI-DI
- B-IM4415126JM, B-EIM4201327EY, B-IM4410126HJ, B-IM4414126JE, B-IM4411126HR, B-EIM4202332EY, B-EIM4201332ER
- EMDN Code
- W0105040304, W0105040303
- Device Class
- Class IVD General
- EU market of registration
- SpainGermany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014618
- Authorised representative
- Humiss International B.V. NL-AR-000001490
Other devices from Maccura Biotechnology Co., Ltd.
Properties
Other properties (6)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No