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IMMULITE®2000 Systems 3gAllergy™ Japanse Cedar
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 10386063Model IVDR_67_LLB_DUB-C_B_REAG_Japanese Cedar Spfc Algn
Identity
- Trade Name
- IMMULITE 2000 Japanese Cedar Specific Allergen EUDAMEDIMMULITE®2000 Systems 3gAllergy™ Japanse Cedar FDA UDI
- Generic Name
- Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent FDA UDI
- Device Name
- IVDR_67_LLB_DUB-C_B_REAG_Japanese Cedar Spfc Algn EUDAMEDJapanese Cedar -Specific IgE - IMMULITE - RGT FDA UDI
- Model / Reference
- 10386063 EUDAMEDFDA UDIIVDR_67_LLB_DUB-C_B_REAG_Japanese Cedar Spfc Algn EUDAMED
- Description
- Japanese Cedar -Specific IgE - IMMULITE - RGT FDA UDI
Identifiers
- Catalog Number
- T17L4 FDA UDI
- Primary DI / UDI-DI
- 00630414965192 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686900477VS EUDAMED
- 510(k) Number
- K013134 FDA UDI
- FDA Product Code
- DHB FDA UDI
- EMDN Code
- W01020202 IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT EUDAMED
- GMDN Term
- Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5750 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Category: Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
IMMULITE®2000 Systems 3gAllergy™ Japanse Cedar by Siemens Healthcare Diagnostics Products Ltd — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Cleared under the same submission
K013134 also covers:
- IMMULITE Systems 3gAllergy Specific IgE Positive Control For D1 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® 2000 Systems 3gAllergy™ Cultivated Wheat Grass — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Alternaria tenuis — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Bahia Grass — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Bakers Yeast — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Bermuda Grass — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Buckwheat — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Candida albicans — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Carrot — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Casein — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Celery — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Cladosporium herbarum — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (2)
- FDA UDI 1afae551-c42c-4853-a899-20ab667c594b 37 fields · synced Oct 7, 2026
- EUDAMED 38637852-8471-43f9-9988-c77aeb9e272f 61 fields · synced Oct 7, 2026