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ONE STEP Anti-HIV (1&2) Test

by InTec PRODUCTS, INC. 4 variants

Ref ITP02152-TC25

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE IVDD, withdrawn

Ended

Withdrawn

Date not published (CE IVDD)

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06936155804320 Basic UDI-DI 06936155804320UDI-DIDate25 Oct 2023RegisteredStatusWithdrawn No longer placed on the EU market

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  • Withdrawn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European Union — CE/IVDD Withdrawn

Specification

EUDAMED

Device Name
ONE STEP Anti-HIV (1&2) Test
Model / Reference
ITP02152-TC25
Primary DI / UDI-DI
06936155804320
Basic UDI-DI
B-06936155804320
EMDN Code
W0105030402 HIV multiple antibody
Device Class
Class IVD Annex II List A

Manufacturer details

EUDAMED SRN
CN-MF-000023625
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from InTec PRODUCTS, INC.

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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