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AccuDiag™ Human Specific IgE (20 Perennial Allergens)
EUDAMEDClass IVD General (EU MDR)
Ref 5253-8Model Allergy Immunoblot Assay
Identity
- Trade Name
- AccuDiag™ Human Specific IgE (20 Perennial Allergens) EUDAMED
- Device Name
- AccuDiag™ Human Specific IgE (20 Perennial Allergens) EUDAMED
- Model / Reference
- Allergy Immunoblot Assay EUDAMED5253-8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850049545655 EUDAMED
- Basic UDI-DI
- B-00850049545655 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 Perennial 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-00850049545655 | 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 e95afd72-5a21-459e-872e-1513a6a255d2 61 fields · synced Jul 16, 2026