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IMMULITE®2000 Systems 3gAllergy™ Orange 10385803

by Siemens Healthcare Diagnostics Products Ltd

Ref 10385803Model IVDR_67_LLB_DUB-C_B_REAG_Orange Specific Allergen

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686900553VH Basic UDI-DI 00630414960098UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414960098 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

2 recalls · FDA

    • Terminated Z-1674-2018 FDA Class II initiated 2 Jan 2018

    Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

    • Terminated Z-1843-2015 FDA Class II initiated 6 May 2015

    IMMULITE 2000/2000XPi Italian Cypress (T23L4), Lots 206 and 208, fail to meet specifications to support the shelf-life stability of 2 years (24 months) expiration date as indicated on the products label.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
IMMULITE 2000 Orange Specific Allergen EUDAMED
IMMULITE®2000 Systems 3gAllergy™ Orange GUDID
Generic Name
Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Device Name
IVDR_67_LLB_DUB-C_B_REAG_Orange Specific Allergen
Model / Ref / Catalog
10385803, IVDR_67_LLB_DUB-C_B_REAG_Orange Specific Allergen, F33L4
Primary DI / UDI-DI
00630414960098
Basic UDI-DI
0405686900553VH
510(k) Number
FDA Product Code
DHB
EMDN Code
W01020202 Immunoglobulin e - specific, monotest/monoresult
GMDN Term
Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Device Class
Class B EUDAMED
Class II GUDID
Regulation Number
866.5750
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class B
GUDID
Class II

Related devices

Category: Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

Cleared under the same submission (K013134)

Show all (12)

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • 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
  • Serial Number: No
  • Manufacturing Date: No