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INSTI HIV Self Test (no pipette variant, packaged in pouch)
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref 90-1041-012 and 90-1041-013
Identity
- Trade Name
- INSTI HIV Self Test (no pipette variant, packaged in pouch) EUDAMED
- Device Name
- INSTI HIV Self Test CE roen 10 and INSTI HIV Self Test CE roen 250 EUDAMED
- Model / Reference
- 90-1041-012 and 90-1041-013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00686597201770 EUDAMED
- Basic UDI-DI
- B-00686597201770 EUDAMED
- EMDN Code
- W0105030402 HIV MULTIPLE ANTIBODY EUDAMED
Classification
- Device Class
- Class IVD Annex II List A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
INSTI HIV Self Test (no pipette variant, packaged in pouch) by Biolytical Laboratories Inc. — Class IVD Annex II List A — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00686597201770 | Class IVD Annex II List A | Active |
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Manufacturer
- Manufacturer
- bioLytical Laboratories Inc.
- EUDAMED SRN
- CA-MF-000023304
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED dd72c6df-8292-4842-ac66-d02e78790d11 61 fields · synced Sep 17, 2026