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Zestaw SIT OH-Sal Szybki identyfikacyjny test do diagnostyki in vitro bakterii z rodzaju Salmonella spp.

by Zakład Badawczo-Wdrożeniowy Ośrodka Salmonella IMMUNOLAB Sp. z o.o.

Ref PS006

Active European Union

CE IVDR

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number590575374PS006FA Basic UDI-DI 05905753743806UDI-DIDate26 Jul 2024RegisteredStatusActive

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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device Name
SIT OH-Sal Kit Quick Identification Test for in vitro diagnostic of Salmonella spp.
Model / Reference
PS006
Primary DI / UDI-DI
05905753743806
Basic UDI-DI
590575374PS006FA
EMDN Code
W0104080301 Serotyping (e.coli, salmonella, shigella, etc)
Device Class
Class A
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000042563

Other devices from Zakład Badawczo-Wdrożeniowy Ośrodka Salmonella IMMUNOLAB Sp. z o.o.

See all devices from Zakład Badawczo-Wdrożeniowy Ośrodka Salmonella IMMUNOLAB Sp. z o.o. →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

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