Artron Human Immunodeficiency Virus (HIV 1/2) Antibody Test
Ref A02-07-322P25Model Cassette
Active
CE IVDR
Valid until
6 Aug 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number62834756AL0207026X 00628347561031 | Date24 Feb 2026 | StatusActive |
Certificates
- 2024-IVDR/QS-007/B Active
Quality management system EU IVDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 27 Jan 2026
- Expires
- 6 Aug 2029
- Reason
- Other
- 2024-IVDR/TD-007/B Active
Technical documentation EU IVDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 27 Jan 2026
- Expires
- 6 Aug 2029
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Human Immunodeficiency Virus (HIV 1/2) Antibody Test
- Model / Reference
- Cassette, A02-07-322P25
- Primary DI / UDI-DI
- 00628347561031
- Basic UDI-DI
- 62834756AL0207026X
- EMDN Code
- W0105090302 HIV 1 / 2 - rt & poc
- Device Class
- Class D
- EU market of registration
- Romania
Manufacturer details
- EUDAMED SRN
- CA-MF-000028974
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
From the manufacturer
Manufacturer's product page: Artron HCG Pregnancy Test
Other devices from Artron Laboratories Inc.
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No