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LAMP Human Hemoglobin S&C mutation KIT (rs334/rs33930165)

by LaCAR MDx Technologies 2 variants

Ref LC-HbS/C-LPModel LC-HbS/C-LP-96

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-05430002471525 Basic UDI-DI 05430002471525UDI-DIDate20 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  • Withdrawn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

Model / Reference
LC-HbS/C-LP-96, LC-HbS/C-LP
Primary DI / UDI-DI
05430002471525
Basic UDI-DI
B-05430002471525
EMDN Code
W0106010109 Sickle cell anemia
Device Class
Class IVD General
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000001212

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See all devices from Lacar MDX Technologies →

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