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Anti-gliadin sIgA / IgA ELISA (96 tests)
EUDAMEDClass IVD General (EU MDR)
Ref IC6300
Identity
- Device Name
- Anti-gliadin sIgA / IgA ELISA (96 tests) EUDAMED
- Model / Reference
- IC6300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260154636302 EUDAMED
- Basic UDI-DI
- B-04260154636302 EUDAMED
- EMDN Code
- W0102100604 GLIADIN ANTIBODIES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Anti-gliadin sIgA / IgA ELISA (96 tests) by ImmuChrom GmbH — Class IVD General — 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-04260154636302 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- ImmuChrom GmbH
- EUDAMED SRN
- DE-MF-000033427
Sources (2)
- EUDAMED 177159fe-917d-4f86-8036-598e0b07e1a5 61 fields · synced Jun 19, 2026
- EUDAMED 1979262f-af26-41c2-bd8d-8e40778cbe1d 61 fields · synced Jun 19, 2026