Nucleic Acid Extraction and Purification Kit (Magnetic)
by Shenzhen Sciarray Biotech Co., Ltd. China EUDAMED
Ref 64 tests/ kitModel Unfilled deep-well plates: 48 tests/ kit, 96 tests/ kit Pre-filled deep-well plates: 32 tests/ kit, 64 tests/ kit EMDN W01019099
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697549176NAEAPK02E3 | Date24 Oct 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Nucleic Acid Extraction and Purification Kit (Magnetic)
- Model / Reference
- Unfilled deep-well plates: 48 tests/ kit, 96 tests/ kit Pre-filled deep-well plates: 32 tests/ kit, 64 tests/ kit
- Primary DI / UDI-DI
- 06975491760044
- Basic UDI-DI
- 697549176NAEAPK02E3
- 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 & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 437e2aff-422a-4c08-9013-b6d2068345a8