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Human IgG3 Subclass (Latex) Bulk Kit (for Siemens BN™II)

by The Binding Site Group Ltd

Ref LK008.2TB

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

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-05051700006101 Basic UDI-DI 05051700006101UDI-DIDate27 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05051700006101 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 24 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Human IgG3 Subclass (Latex) Bulk Kit (for Siemens BN™II) EUDAMED
Human IgG3 Subclass Liquid Reagent Kit for use on the Siemens BN™II - Bulk Kit GUDID
Generic Name
Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
Model / Reference
LK008.2TB
Primary DI / UDI-DI
05051700006101
Basic UDI-DI
B-05051700006101
510(k) Number
FDA Product Code
CFN
EMDN Code
W0102010106 Immunoglobulin g subclass reagents
GMDN Term
Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
Device Class
Class IVD General EUDAMED
Class II GUDID
Regulation Number
866.5510
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IVD General
GUDID
Class II

Manufacturer details

EUDAMED SRN
UK-MF-000036707
Authorised representative
The Binding Site Ireland Limited IE-AR-000034426

Other devices from The Binding Site Group Ltd

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Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (15)

  • 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
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No