BioCLIA Autoimmune Reagent Kit, Jo-1
by HOB Biotech Group Corp., Ltd. 2 variants
Ref MY00153Model Jo-1, 100 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-06924030402686 06924030402686 | Date28 Aug 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- Withdrawn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/IVDD Active
Specification
- Model / Reference
- Jo-1, 100 Tests/Kit, MY00153
- Primary DI / UDI-DI
- 06924030402686
- Basic UDI-DI
- B-06924030402686
- EMDN Code
- W0102100108 Jo-1
- Device Class
- Class IVD General
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000023974
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from HOB Biotech Group Corp., Ltd.
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