Identity
- Trade Name
- Specific IgE ELISA (XL Kit) EUDAMED
- Device Name
- Specific IgE ELISA (XL Kit) EUDAMED
- Model / Reference
- 36080000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260153756421 EUDAMED
- Basic UDI-DI
- B-04260153756421 EUDAMED
- EMDN Code
- W01020202 IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Specific IgE ELISA (XL Kit) by Gold Standard Diagnostics Kassel GmbH — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent.
- IMMULITE®2000 Systems 3gAllergy™ Chicken Feathers — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- ImmunoCAP Allergen c73, Insulin human — Phadia AB · Class B
- BioCLIA Allergy Reagent Kit, I6 — HOB Biotech Group Corp., Ltd. · IVD General
- ImmunoCAP Rare Allergen e217, Ferret epithelium — Phadia AB · Class B
- e1 CLIA Microparticles — Autobio Diagnostics Co., Ltd. · Class B
- Sharay Specific IgE (Mix of 22 items) (CLIA) — C-Luminary Biotechnology Co., Ltd. · IVD General
- BioCLIA Allergy Reagent Kit, F88 — HOB Biotech Group Corp., Ltd. · IVD General
- Sharay Specific IgE (19 Allergens) (CLIA) — C-Luminary Biotechnology Co., Ltd. · IVD General
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-04260153756421 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gold Standard Diagnostics Kassel GmbH
- EUDAMED SRN
- DE-MF-000021646
Sources (1)
- EUDAMED 348c5135-7ebe-45ba-8984-d049355f0d10 61 fields · synced Jul 14, 2026