Nucleic Acid Extraction and Methylation Conversion Kit
by Shenzhen Sciarray Biotech Co., Ltd. 5 variants
Ref 16 tests/ kitModel 8 tests/ kit, 16 tests/ kit, 32 tests/ kit, 48 tests/ kit, 96 tests/ kit
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697549176NAEAMCK3C 06975491760075 | Date24 Oct 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- Withdrawn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/IVDR Active
Specification
- Device Name
- Nucleic Acid Extraction and Methylation Conversion Kit
- Model / Reference
- 8 tests/ kit, 16 tests/ kit, 32 tests/ kit, 48 tests/ kit, 96 tests/ kit
- Primary DI / UDI-DI
- 06975491760075
- Basic UDI-DI
- 697549176NAEAMCK3C
- EMDN Code
- W01019099 Clinical chemistry reagents - other
- Device Class
- Class A
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000038307
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shenzhen Sciarray Biotech Co., Ltd.
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No