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IMMULITE®2000 Systems 3gAllergy™ Lamb 10385865

by Siemens Healthcare Diagnostics Products Ltd

Ref 10385865Model IVDR_67_LLB_DUB-C_B_REAG_Lamb Specific Allergen

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686900483VM Basic UDI-DI 00630414960302UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414960302 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

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

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  • Withdrawn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 Lamb Specific Allergen EUDAMED
IMMULITE®2000 Systems 3gAllergy™ Lamb GUDID
Generic Name
Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Device Name
IVDR_67_LLB_DUB-C_B_REAG_Lamb Specific Allergen
Model / Ref / Catalog
10385865, IVDR_67_LLB_DUB-C_B_REAG_Lamb Specific Allergen, F88L2
Primary DI / UDI-DI
00630414960302
Basic UDI-DI
0405686900483VM
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 (K091984)

Show all (12)

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Properties

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

Other properties (18)

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