INSTI HIV Self Test (no pipette variant, packaged in a box)
by bioLytical Laboratories Inc. Canada EUDAMED
Ref 90-1056 EMDN W0105030402
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-00686597010563 | Date25 May 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- INSTI HIV Self Test
- Model / Reference
- 90-1056
- Primary DI / UDI-DI
- 00686597010563
- Basic UDI-DI
- B-00686597010563
- EMDN Code
- W0105030402 HIV multiple antibody
- Device Class
- Class IVD Annex II List A
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CA-MF-000023304
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Biolytical Laboratories Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 0f618d6f-ff80-41bf-9d32-a0f10b733399