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INSTI HIV Self Test (no pipette variant, packaged in a box)

by bioLytical Laboratories Inc. 11 variants

Ref 90-1057

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00686597010570 Basic UDI-DI 00686597010570UDI-DIDate25 May 2022RegisteredStatusActive

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  • Withdrawn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 Active

Specification

EUDAMED

Device Name
INSTI HIV Self Test
Model / Reference
90-1057
Primary DI / UDI-DI
00686597010570
Basic UDI-DI
B-00686597010570
EMDN Code
W0105030402 HIV multiple antibody
Device Class
Class IVD Annex II List A
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CA-MF-000023304
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Biolytical Laboratories Inc.

See all devices from Biolytical Laboratories Inc. →

Properties

  • Self Testing

Other properties (9)

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