ZiXpress Whole Blood Genomic DNA Extraction Kit (96)
Ref 312A021A
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
ZiXpress Whole Blood Genomic DNA Extraction Kit (96) is a cutting-edge, user-friendly device for obtaining high-quality genomic DNA from whole blood samples. This innovative kit features a proprietary technology that allows for efficient and accurate extraction of DNA from even the smallest sample sizes, making it an ideal choice for various medical applications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number471988968312A024Q 04719889680567 | Date28 Jan 2026 | 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- Withdrawn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
- Model / Reference
- 312A021A
- Primary DI / UDI-DI
- 04719889680567
- Basic UDI-DI
- 471988968312A024Q
- EMDN Code
- W02069085 Various sample processing instruments - consumables
- Device Class
- Class A
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- TW-MF-000026758
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Zinexts Life Science Corp.
Properties
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No