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DeepChek® Assay INTEGRASE Genotyping and Drug Resistance

by Advanced Biological Laboratories (Abl) S.A.

Ref 122A24

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05407007960019 Basic UDI-DI 05407007960019UDI-DIDate11 Sep 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  • Withdrawn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

Device Name
DeepChek® Assay INTEGRASE Genotyping and Drug Resistance V1.X
Model / Reference
122A24
Primary DI / UDI-DI
05407007960019
Basic UDI-DI
B-05407007960019
EMDN Code
W0105030108 HIV 1 genotyping - na reagents
Device Class
Class IVD General
EU market of registration
Luxembourg

Manufacturer details

EUDAMED SRN
LU-MF-000003752

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Properties

  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

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