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Acanthocheilonema viteae IgG ELISA

by Bordier Affinity Products SA Switzerland EUDAMEDGUDID

Ref 9400 Product code LIBEMDN W0105050299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number76401582194002K Basic UDI-DIDate21 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07640158219409 UDI-DIDate28 Sep 2022ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Generic Name
Wuchereria bancrofti immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
9400
Primary DI / UDI-DI
07640158219409
Basic UDI-DI
76401582194002K, B-07640158219409
Direct Marketing DI
07640158219409
FDA Product Code
LIB
EMDN Code
W0105050299 Parasitology - other
GMDN Term
Wuchereria bancrofti immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Device Class
Class B EUDAMED
Class IVD General EUDAMED
Class I GUDID
Regulation Number
866.2660
Market of Registration
France
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class B
Class IVD General
GUDID
Class I

Manufacturer details

EUDAMED SRN
CH-MF-000025247
Authorised representative
Leman Diagnostics SARL FR-AR-000024185

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Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Animal Tissues
  • Reagent
  • Professional Testing
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
Other properties (16)
  • Sterile: 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
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (3)

  • EUDAMED b8e7acbc-dc9f-4c85-b2bf-f4921e676b9c 61 fields · synced 24 Oct 2026
  • EUDAMED 07640158219409|B-07640158219409 61 fields · synced 18 May 2026
  • FDA UDI 5cefd393-04f1-46cf-98de-e1266a686ed8 36 fields · synced 29 May 2026