Skip to content

Strep A Rapid Test Cassette

by Citest Diagnostics Inc EUDAMED

Active European Union

Ref IST-502(CT)

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-IST-502(CT)Q4 Basic UDI-DIDate30 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Strep A Rapid Test Cassette
Model / Reference
IST-502(CT)
Primary DI / UDI-DI
D-IST-502(CT)Q4
Basic UDI-DI
B-IST-502(CT)Q4
EMDN Code
W0105090103 Strep. a - rt & poc
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CA-MF-000022516
Authorised representative
VidaQuick Biotech S.L. ES-AR-000048138

Other devices from Citest Diagnostics Inc

See all devices from Citest Diagnostics Inc →

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