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INSTI Multiplex HIV-1/2 Syphilis Ab Test
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref 90-1028-008Ref 90-1028-019 and 90-1028-020Ref 90-1028-010Ref 90-1028-013 and 90-1028-014Ref 90-1028-011 and 90-1028-012Ref 90-1028-003 and 90-1028-004
Identity
- Trade Name
- INSTI Multiplex HIV-1/2 Syphilis Ab Test EUDAMED
- Device Name
- INSTI Multiplex Test CE cs 350 EUDAMEDINSTI Multiplex Test CE es 50 and INSTI Multiplex Test CE es 350 EUDAMEDINSTI Multiplex Test CE fi 350 EUDAMEDINSTI Multiplex Test CE it 50 and INSTI Multiplex Test CE it 350 EUDAMEDINSTI Multiplex Test CE de 50 and INSTI Multiplex Test CE de 350 EUDAMEDINSTI Multiplex Test CE fr 50 and INSTI Multiplex Test CE fr 350 EUDAMED
- Model / Reference
- 90-1028-008 EUDAMED90-1028-019 and 90-1028-020 EUDAMED90-1028-010 EUDAMED90-1028-013 and 90-1028-014 EUDAMED90-1028-011 and 90-1028-012 EUDAMED90-1028-003 and 90-1028-004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00686597200483 EUDAMED00686597201831 EUDAMED00686597200506 EUDAMED00686597201336 EUDAMED00686597200278 EUDAMED00686597200445 EUDAMED
- Basic UDI-DI
- B-00686597200483 EUDAMEDB-00686597201831 EUDAMEDB-00686597200506 EUDAMEDB-00686597201336 EUDAMEDB-00686597200278 EUDAMEDB-00686597200445 EUDAMED
- EMDN Code
- W0105010302,W0105030402 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
EUDAMEDEUDAMED
Near-Patient Testing
Yes
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
INSTI Multiplex HIV-1/2 Syphilis Ab 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-00686597200483 | 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 (6)
- EUDAMED f4125c67-f388-462c-8b21-e267fcfb2683 61 fields · synced Jul 30, 2026
- EUDAMED f14c1aa4-ecad-462e-a96b-8b9334494e1d 61 fields · synced May 17, 2026
- EUDAMED 42bb08dc-b65f-4f38-80db-60765db70c19 61 fields · synced May 17, 2026
- EUDAMED 4e9d16c4-7333-4640-9bc5-1f6240424076 61 fields · synced May 17, 2026
- EUDAMED 9045ba58-20e9-44e5-8688-a41b2e2a1454 61 fields · synced May 18, 2026
- EUDAMED 40de7597-6137-41b5-b9cf-cb556afcd769 61 fields · synced May 19, 2026