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Direct HLA B27 Real Time PCR Kit

by Snp Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Ve Üreti̇m Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇li̇mi̇ted

Ref 501R-10-03

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-08680422281656 Basic UDI-DI 08680422281656UDI-DIDate15 Oct 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  • Withdrawn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
501R-10-03
Primary DI / UDI-DI
08680422281656
Basic UDI-DI
B-08680422281656
EMDN Code
W0106010199 Monogenetic disorders tests - other
Device Class
Class IVD General
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000036548

From the manufacturer

Manufacturer's product page: Mutasyon Real-Time PCR Kitleri

Other devices from Snp Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Ve Üreti̇m Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇li̇mi̇ted

See all devices from Snp Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Ve Üreti̇m Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇li̇mi̇ted →

Properties

  • Reagent
  • Professional Testing

Other properties (8)

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