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Aptima® MULTITEST SWAB COLLECTION KIT, APTIMA, IVD

by Hologic

Part of a family of 11 devices: see the family page

Ref PRD-03546

Aptima® MULTITEST SWAB COLLECTION KIT, APTIMA, IVD (PRD-03546) is a device classified as Class A in the EU and Class II in the US made by Hologic, registered in EUDAMED on 23 Jun 2026 (Basic UDI-DI 54200455DIAGCOLLECTVT), cleared under FDA 510(k) K162673 on 15 Jun 2017 and listed in FDA GUDID since 16 Jan 2018 (UDI-DI 25420045510187), active as of 25 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 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number54200455DIAGCOLLECTVT Basic UDI-DI 25420045510187UDI-DIDate23 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number25420045510187 UDI-DI Date16 Jan 2018ListedStatusListed 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 54200455DIAGCOLLECTVT registered 23 Jun 2026 Active
  • FDA 510(k) K162673 decided 15 Jun 2017 Active
  • FDA GUDID UDI-DI 25420045510187 listed 16 Jan 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K162673
  2. Listed FDA GUDID 25420045510187
  3. Registered EUDAMED 54200455DIAGCOLLECTVT

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  • Withdrawn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 Multitest Swab Specimen Collection Kit EUDAMED
Aptima® GUDID
Generic name
Urogenital specimen collection kit IVD, clinical
Device name
Collection, Transport and Lysis Kits
Model / Ref / Catalog
PRD-03546, MULTITEST SWAB COLLECTION KIT, APTIMA, IVD
Primary DI / UDI-DI
25420045510187
Basic UDI-DI
54200455DIAGCOLLECTVT
Unit of use DI
15420045510180
510(k) Number
FDA product code
OQO
EMDN code
W05019099 Samples collection devices - other
GMDN term
Urogenital specimen collection kit IVD, clinical
Device class
Class A 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-03546
GUDID
MULTITEST SWAB COLLECTION KIT,APTIMA,IVD
Device classEUDAMED
Class A
GUDID
Class II

Device class is stated on each registry's own scale: Class A 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: Urogenital specimen collection kit IVD, clinical

Cleared under the same submission (K162673)

Similar devices in this category

Other devices filed under SAMPLES COLLECTION DEVICES - OTHER.

Other devices from Hologic

See all devices from Hologic →

Properties

  • IVD kit
  • Professional testing
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)