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Fuller Laboratories by VMRD Orientia tsutsugamushi MIF IgG Antibody Kit

by VMRD, Inc.

Ref OTG-100

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00850078245199 Basic UDI-DI 00850078245199UDI-DIDate9 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Orientia tsutsugamushi MIF IgG Antibody Kit
Model / Reference
OTG-100
Primary DI / UDI-DI
00850078245199
Basic UDI-DI
B-00850078245199
EMDN Code
W0105011799 Bacteriology immunoassay - other
Device Class
Class IVD General
EU market of registration
Netherlands

Manufacturer details

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

Other devices from VMRD, Inc.

See all devices from VMRD, Inc. →

Properties

  • Animal Tissues
  • Microbial Substances
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No