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Fuller Laboratories by VMRD Babesia divergens IFA IgG Antibody Kit

by VMRD, Inc. United States EUDAMED

Ref DVG-120

EMDN W0105050299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00850078245052 Basic UDI-DIDate6 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Babesia divergens IFA IgG Antibody Kit
Model / Reference
DVG-120
Primary DI / UDI-DI
00850078245052
Basic UDI-DI
B-00850078245052
EMDN Code
W0105050299 Parasitology - other
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000049394
Authorised representative
MediMark Europe Sarl. FR-AR-000000182

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED de5f215b-f652-4dc3-828d-c0c1e1254b34 61 fields · synced 24 Oct 2026