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AccuDiag™ Human Specific IgE (20 Seasonal Allergens)
EUDAMEDClass IVD General (EU MDR)
Ref 5150-8Model Allergy Immunoblot Assay
Identity
- Trade Name
- AccuDiag™ Human Specific IgE (20 Seasonal Allergens) EUDAMED
- Device Name
- AccuDiag™ Human Specific IgE (20 Seasonal Allergens) EUDAMED
- Model / Reference
- Allergy Immunoblot Assay EUDAMED5150-8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-AB5150ZR445Q EUDAMED
- Basic UDI-DI
- B-AB5150ZR445Q EUDAMED
- EMDN Code
- W01020202 IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Category: Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
AccuDiag™ Human Specific IgE (20 Seasonal Allergens) by Diagnostic Automation/ Cortez Diagnostics, Inc. — Class IVD General — IVDD — listed in EUDAMED
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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-AB5150ZR445Q | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Diagnostic Automation/ Cortez Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000051963
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED c879298c-9043-43d7-89ae-13db09bb84ad 61 fields · synced Jul 21, 2026