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Aptima® KIT, CONTROLS, AHSV, 100T, IVD

by Hologic

Ref PRD-03569

Aptima® KIT, CONTROLS, AHSV, 100T, IVD (PRD-03569) is a device classified as Class C in the EU and Class II in the US made by Hologic, registered in EUDAMED on 27 May 2026 (Basic UDI-DI 54200455DIAGAPTHSV12S7), cleared under FDA 510(k) K162673 on 15 Jun 2017 and listed in FDA GUDID since 23 Jun 2017 (UDI-DI 15420045507234), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K162673

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number54200455DIAGAPTHSV12S7 Basic UDI-DI 15420045507234UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number15420045507234 UDI-DI Date23 Jun 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK162673 Date15 Jun 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 54200455DIAGAPTHSV12S7 registered 27 May 2026 Active
  • FDA 510(k) K162673 decided 15 Jun 2017 Active
  • FDA GUDID UDI-DI 15420045507234 listed 23 Jun 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K162673
  2. Listed FDA GUDID 15420045507234
  3. Registered EUDAMED 54200455DIAGAPTHSV12S7

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Aptima Herpes Simplex Viruses 1 & 2 Assay Controls Kit EUDAMED
Aptima® GUDID
Generic name
Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
Device name
Aptima Herpes Simplex Viruses 1 & 2 Assay
Model / Ref / Catalog
PRD-03569, KIT, CONTROLS, AHSV, 100T, IVD
Primary DI / UDI-DI
15420045507234
Basic UDI-DI
54200455DIAGAPTHSV12S7
Unit of use DI
05420045507237
510(k) Number
FDA product code
OQO
EMDN code
W0105080804 Other virology controls - inf.imm.
GMDN term
Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
Device class
Class C EUDAMED
Class II GUDID
Regulation number
866.3305
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
PRD-03569
GUDID
KIT, CONTROLS, AHSV, 100T, IVD
Device classEUDAMED
Class C
GUDID
Class II

Device class is stated on each registry's own scale: Class C in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control

Cleared under the same submission (K162673)

Similar devices in this category

Other devices filed under OTHER VIROLOGY CONTROLS - INF.IMM..

Other devices from Hologic

See all devices from Hologic →

Properties

  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)