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A Fluorescence Immunoassay for the qualitative detection of Rotavirus antigen and Adenovirus antigen in human feces, as an aid in the diagnosis of Rotavirus and/or Adenovirus infection.

by Acro Biotech Inc.

Ref ACO-RAC-602

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-ACO-RAC-602MM Basic UDI-DI D-ACO-RAC-602MMUDI-DIDate3 Aug 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  • Withdrawn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

Model / Reference
ACO-RAC-602
Primary DI / UDI-DI
D-ACO-RAC-602MM
Basic UDI-DI
B-ACO-RAC-602MM
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class IVD General
EU market of registration
Finland

Manufacturer details

EUDAMED SRN
US-MF-000017832
Authorised representative
VidaQuick Biotech S.L. ES-AR-000048138

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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