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Insti Hiv-1/Hiv-2 Antibody Test

EUDAMED

Class IVD Annex II List A (EU MDR)

Ref 90-1015-009Ref 90-1015-005 and 90-1015-006Ref 90-1015-015 and 90-1015-016

by bioLytical Laboratories Inc.

Identity

Trade Name
INSTI HIV-1/HIV-2 ANTIBODY TEST EUDAMED
Device Name
INSTI HIV Ab Test CE BE fr 350 EUDAMED
INSTI HIV Ab Test CE de 50 and INSTI HIV Ab Test CE de 350 EUDAMED
INSTI HIV Ab Test CE pt 50 and INSTI HIV Ab Test CE pt 350 EUDAMED
Model / Reference
90-1015-009 EUDAMED
90-1015-005 and 90-1015-006 EUDAMED
90-1015-015 and 90-1015-016 EUDAMED

Identifiers

Primary DI / UDI-DI
00686597200407 EUDAMED
00686597200377 EUDAMED
00686597202067 EUDAMED
Basic UDI-DI
B-00686597200407 EUDAMED
B-00686597200377 EUDAMED
B-00686597202067 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

No

EUDAMEDEUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

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

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Manufacturer

Manufacturer
bioLytical Laboratories Inc.
EUDAMED SRN
CA-MF-000023304
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (3)

  • EUDAMED 4564616d-d5a9-4220-a4db-d87113ab27fd 61 fields · synced Sep 17, 2026
  • EUDAMED b71d234d-7b9b-483d-a1f1-f19dc4ad4bc6 61 fields · synced May 17, 2026
  • EUDAMED fca91af1-1b6b-4c77-91bc-fb48a7e490f2 61 fields · synced May 17, 2026