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IMMULITE®2000 Systems 3gAllergy™ Glyceyphagus domesticus 10385638

by Siemens Healthcare Diagnostics Products Ltd

Ref 10385638Model IVDR_67_LLB_DUB-C_B_REAG_Glycy. domesticus Spfc Algn

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686900421UX Basic UDI-DI 00630414975245UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414975245 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  • Withdrawn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 Glycyphagus domesticus Specific Allergen EUDAMED
IMMULITE®2000 Systems 3gAllergy™ Glyceyphagus domesticus GUDID
Generic Name
Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Device Name
IVDR_67_LLB_DUB-C_B_REAG_Glycy. domesticus Spfc Algn
Model / Ref / Catalog
10385638, IVDR_67_LLB_DUB-C_B_REAG_Glycy. domesticus Spfc Algn, D73L2
Primary DI / UDI-DI
00630414975245
Basic UDI-DI
0405686900421UX
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
  • Microbial Substances
  • Reagent
  • Professional Testing
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: 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