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IDS Specific IgE (T215) rBet v 1
EUDAMEDClass IVD General (EU MDR)
Ref IS-1T215
Identity
- Trade Name
- IDS Specific IgE (T215) rBet v 1 EUDAMED
- Device Name
- IDS Specific IgE (T215) rBet v 1 EUDAMED
- Model / Reference
- IS-1T215 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060169695153 EUDAMED
- Basic UDI-DI
- B-05060169695153 EUDAMED
- EMDN Code
- W01020202 IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Category: Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
For accurate immunodiagnostic testing, the IDS Specific IgE (T215) rBet v 1 device uses a patented immunochromatographic method to detect specific IgE antibodies in patient samples. This technology provides reliable and rapid results for diagnosing allergies and other immune system disorders.
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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-05060169695153 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Immunodiagnostic Systems Limited
- EUDAMED SRN
- GB-MF-000015851
- Authorised Representative
- Immunodiagnostic Systems SA BE-AR-000015342
Sources (1)
- EUDAMED cc2274c0-2039-4063-8688-35201561c00d 61 fields · synced Jul 12, 2026