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Immunoglobulin A

by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇ 3 variants

Ref B21191, B35190, B33190, B45190, B27191Model Immunoglobulin A 39 mL, Immunoglobulin A Kit 50mL, Immunoglobulin A Kit 100mL, Immunoglobulin A Kit, IgA Kit 50mL

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08683555610614 Basic UDI-DI Date4 Apr 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  • Withdrawn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

Trade Name
Immunoglobulin A
Immunoglobulin A Kit
Model / Reference
Immunoglobulin A 39 mL, B21191, Immunoglobulin A Kit 50mL, B35190, Immunoglobulin A Kit 100mL, B33190, Immunoglobulin A Kit, B45190, IgA Kit 50mL, B27191
Primary DI / UDI-DI
08683555610614, 08683555617415, 08683555615947, 08683555622495, 08683555612878
Basic UDI-DI
B-08683555610614, B-08683555617415, B-08683555615947, B-08683555622495, B-08683555612878
EMDN Code
W0103080202 Iga, igd, igm, igg, ige
Device Class
Class IVD General
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000040334

Other devices from Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇

See all devices from Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇ →

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