IMMULITE 2000 rMal d 1 Specific Allergen
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- IMMULITE 2000 rMal d 1 Specific Allergen EUDAMEDFDA UDI
- Generic Name
- Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent FDA UDI
- Device Name
- IVDR_67_LLB_DUB-C_B_REAG_rMal d 1 Specific Allergen EUDAMEDrMal d 1 Allergen FDA UDI
- Model / Reference
- 10483381 EUDAMEDFDA UDIIVDR_67_LLB_DUB-C_B_REAG_rMal d 1 Specific Allergen EUDAMED
- Description
- rMal d 1 Allergen FDA UDI
Identifiers
- Catalog Number
- A464L2 FDA UDI
- Primary DI / UDI-DI
- 00630414006246 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686900624VF EUDAMED
- 510(k) Number
- K132801 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 rMal d 1 Specific Allergen by Siemens Healthcare Diagnostics Products Ltd — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent.
- ImmunoCAP Allergen c73, Insulin human — Phadia AB · Class B
- BioCLIA Allergy Reagent Kit, I6 — HOB Biotech Group Corp., Ltd. · IVD General
- Allergen Discs Serpula lacrymans — Gold Standard Diagnostics Kassel GmbH · 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
Cleared under the same submission
K132801 also covers:
- IMMULITE 2000 nPru p 3 Specific Allergen — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE 2000 rBet v 2 Specific Allergen — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE 2000 rMal d 4 Specific Allergen — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE 2000 rPru av 1 Specific Allergen — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE 2000 rPru av 3 Specific Allergen — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE 2000 rPru av 4 Specific Allergen — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (2)
- FDA UDI cf40230d-2ef4-4a02-b6e4-12d6d4b79c71 37 fields · synced Oct 6, 2026
- EUDAMED e436a9c5-a4aa-42aa-a4e9-cff1cbef2855 61 fields · synced Jul 9, 2026