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AccuDiagTM Total Human IgE
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 1801-18Model Allergy ELISA Kit
Identity
- Trade Name
- AccuDiagTM Total Human IgE EUDAMEDQMedix™ FDA UDI
- Generic Name
- Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Total Human IgE ELISA Kit EUDAMEDQMedix™Total Human IgE ELISA This test is intended to be used for the qualitative and/or quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergen(s) in a clinical specimen, using an enzyme immunoassay (EIA) method. FDA UDI
- Model / Reference
- Allergy ELISA Kit EUDAMED1801-18 EUDAMEDDACD1801-18 FDA UDI
- Description
- QMedix™Total Human IgE ELISA This test is intended to be used for the qualitative and/or quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergen(s) in a clinical specimen, using an enzyme immunoassay (EIA) method. FDA UDI
Identifiers
- Catalog Number
- 1801-18 FDA UDI
- Primary DI / UDI-DI
- 00850054026477 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00850054026477 EUDAMED
- FDA Product Code
- DGC FDA UDI
- EMDN Code
- W01020201 IMMUNOGLOBULIN E - TOTAL EUDAMED
- GMDN Term
- Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5510 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
AccuDiagTM Total Human IgE by Diagnostic Automation/ Cortez Diagnostics, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00850054026477 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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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 (2)
- EUDAMED e320b914-b172-4691-9e63-b71f4484421d 61 fields · synced Jul 11, 2026
- FDA UDI c7279069-106a-4840-9ce3-c8fc6104ef8b 37 fields · synced May 30, 2026