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IMMULITE®2000 Systems 3gAllergy™ House Dust-Bencard 10385943

by Siemens Healthcare Diagnostics Products Ltd

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00630414960661 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution

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

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
IMMULITE®2000 Systems 3gAllergy™ House Dust-Bencard
Generic Name
Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Model / Ref / Catalog
10385943, H3L2
Primary DI / UDI-DI
00630414960661
510(k) Number
FDA Product Code
DHB
GMDN Term
Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Device Class
Class II
Regulation Number
866.5750
GUDID distribution status
Not in Commercial Distribution

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

  • Lot / Batch Number
  • Expiration Date

Other properties (12)

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