IMMULITE®2000 Systems 3gAllergy™ Scallop
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- IMMULITE 2000 Scallop Specific Allergen EUDAMEDIMMULITE®2000 Systems 3gAllergy™ Scallop FDA UDI
- Generic Name
- Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent FDA UDI
- Device Name
- IVDR_67_LLB_DUB-C_B_REAG_Scallop Specific Allergen EUDAMEDScallop-Specific IgE - IMMULITE - RGT FDA UDI
- Model / Reference
- 10385801 EUDAMEDFDA UDIIVDR_67_LLB_DUB-C_B_REAG_Scallop Specific Allergen EUDAMED
- Description
- Scallop-Specific IgE - IMMULITE - RGT FDA UDI
Identifiers
- Catalog Number
- F338L2 FDA UDI
- Primary DI / UDI-DI
- 00630414996196 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686900641VF EUDAMED
- 510(k) Number
- K090257 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
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
IMMULITE®2000 Systems 3gAllergy™ Scallop 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
K090257 also covers:
- IMMULITE®2000 Systems 3gAllergy™ Cashew — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Clam — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Egg — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Oyster — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Pistacchio — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Walnut — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
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 1409d1df-ac4b-44e5-a7d2-6b60d3e15dfd 37 fields · synced Oct 7, 2026
- EUDAMED 476c3d15-a194-4575-a438-74b82ae64247 61 fields · synced Oct 7, 2026