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48 Insti Hiv-1/Hiv-2 Antibody Test
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref 90-1026-002Ref 90-1026-003
Identity
- Trade Name
- 48 INSTI HIV-1/HIV-2 ANTIBODY TEST EUDAMED
- Device Name
- INSTI HIV Ab Test CE enro 48 EUDAMEDINSTI HIV Ab Test CE pt 48 EUDAMED
- Model / Reference
- 90-1026-002 EUDAMED90-1026-003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00686597201824 EUDAMED00686597201763 EUDAMED
- Basic UDI-DI
- B-00686597201824 EUDAMEDB-00686597201763 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
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
48 Insti Hiv-1/Hiv-2 Antibody Test by Biolytical Laboratories Inc. — Class IVD Annex II List A — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-00686597201824 | 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 (2)
- EUDAMED bff2300a-fe72-42d7-9183-23af0235fc56 61 fields · synced Oct 6, 2026
- EUDAMED 95f1b6cd-53aa-46c7-ad55-cab25ac9721f 61 fields · synced May 19, 2026