Adrenocor Ticotropic Hormore (ACTH) Assay Kit (Chemiluminescent Immunoassay)
by Wuhan Life Origin Biotech Joint Stock Co., Ltd. 3 variants
Ref 25 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-06974986814804 06974986814804 | Date20 Dec 2023 | 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- Withdrawn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
- 25 Tests/Kit
- Primary DI / UDI-DI
- 06974986814804
- Basic UDI-DI
- B-06974986814804
- EMDN Code
- W0102060401 Adrenocorticotropic hormone
- Device Class
- Class IVD General
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000027340
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Wuhan Life Origin Biotech Joint Stock Co., Ltd.
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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