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SPOT-it TREC Screening Kit

by ImmunoIVD AB

Ref 4-2015-T

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 linked in EUDAMED

A group certificate may exist

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 Number7350134361178Q Basic UDI-DI 37350134361176UDI-DIDate16 Sep 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
4-2015-T
Primary DI / UDI-DI
37350134361176
Basic UDI-DI
7350134361178Q, B-37350134361176
Direct Marketing DI
37350134361176
EMDN Code
W0106010199 Monogenetic disorders tests - other
Device Class
Class C
Class IVD General
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000034517

From the manufacturer

Manufacturer's product page: SPOT-itTM TREC & KREC Screening Kit Screening Solution for SCID, XLA

Other devices from ImmunoIVD AB

Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

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