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Insti Hiv Antibody Self-Test
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref 90-1058Ref 90-1057Ref 90-1060Ref 90-1041-014 and 90-1041-015Ref 90-1076Ref 90-1056Ref 90-1041-003 and 90-1041-010Ref 90-1059Ref 90-1076-005 and 90-1076-006Ref 90-1123-001Ref 90-1126-001 and 90-1126-002
Identity
- Trade Name
- INSTI HIV ANTIBODY SELF-TEST EUDAMEDINSTI HIV Self Test (no pipette variant, packaged in a pouch) EUDAMEDINSTI HIV Self Test (no pipette variant, packaged in a box)) EUDAMED
- Device Name
- INSTI HIV ANTIBODY SELF-TEST EUDAMEDINSTI HIV Self Test CE bgen 10 and INSTI HIV Self Test CE bgen 250 EUDAMEDINSTI HIV Self Test UK en 250 and INSTI HIV Self Test UK en 50 EUDAMEDINSTI HIV Self Test CE ennoda 10 and INSTI HIV Self Test CE ennoda 250 EUDAMEDINSTI HIV Self Test CE eelvlt 250 EUDAMEDINSTI HIV Self Test CE elenru 10 and INSTI HIV Self Test CE elenru 250 EUDAMED
- Model / Reference
- 90-1058 EUDAMED90-1057 EUDAMED90-1060 EUDAMED90-1041-014 and 90-1041-015 EUDAMED90-1076 EUDAMED90-1056 EUDAMED90-1041-003 and 90-1041-010 EUDAMED90-1059 EUDAMED90-1076-005 and 90-1076-006 EUDAMED90-1123-001 EUDAMED90-1126-001 and 90-1126-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00686597010587 EUDAMED00686597010570 EUDAMED00686597010600 EUDAMED00686597201794 EUDAMED00686597010761 EUDAMED00686597010563 EUDAMED00686597200544 EUDAMED00686597010594 EUDAMED00686597201428 EUDAMED00686597200889 EUDAMED00686597201244 EUDAMED
- Basic UDI-DI
- B-00686597010587 EUDAMEDB-00686597010570 EUDAMEDB-00686597010600 EUDAMEDB-00686597201794 EUDAMEDB-00686597010761 EUDAMEDB-00686597010563 EUDAMEDB-00686597200544 EUDAMEDB-00686597010594 EUDAMEDB-00686597201428 EUDAMEDB-00686597200889 EUDAMEDB-00686597201244 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 Antibody Self-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-00686597010587 | 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 (12)
- EUDAMED 43839716-2b55-45db-b5db-581809458269 61 fields · synced Aug 1, 2026
- EUDAMED ea77562e-03ea-46c6-b560-55cfbd42fb19 61 fields · synced May 16, 2026
- EUDAMED f8f88807-681c-4c33-9108-4b91542b879a 61 fields · synced May 17, 2026
- EUDAMED 1fe1ab53-4df1-4135-8f7e-ff6369e712b4 61 fields · synced May 17, 2026
- EUDAMED ec6578b2-bc06-42be-a651-3ae23d3419fe 61 fields · synced May 18, 2026
- EUDAMED 0f618d6f-ff80-41bf-9d32-a0f10b733399 61 fields · synced May 18, 2026
- EUDAMED 467e5b1a-78db-4903-96c0-99f38cb3b4fa 61 fields · synced May 18, 2026
- EUDAMED 44e8a5e0-ceaa-4725-bb4f-fc168e863b14 61 fields · synced May 18, 2026
- EUDAMED 6c99df6f-451c-4867-8ddf-7b81bcb5d40e 61 fields · synced Jul 15, 2026
- EUDAMED 2b70e879-685c-467f-afcc-a7c84b1a2754 61 fields · synced Jul 19, 2026
- EUDAMED 3fb3761e-85aa-4ebb-b1ed-823e881ca483 61 fields · synced Jul 28, 2026
- EUDAMED 24bb461b-621c-4d86-88bc-afb2feebba41 61 fields · synced Aug 1, 2026