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Aptima® KIT, BOX 2, ROOM TEMP, ABV, 100T, IVD

by Hologic

Part of a family of 6 devices: see the family page

Ref PRD-05186

Aptima KIT, BOX 2, ROOM TEMP, ABV, 100T, IVD (ASY-11551) is an in vitro diagnostic device (EU IVDR Class B; FDA Class II; EMDN category bacteriology - na reagents) made by Hologic, registered in EUDAMED on 23 Jun 2026 (Basic UDI-DI 54200455DIAGAPTBVRB), cleared under FDA 510(k) K190452 on 23 May 2019 and listed in FDA GUDID since 2 Jul 2019 (UDI-DI 15420045512030), 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) K190452

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 Number54200455DIAGAPTBVRB Basic UDI-DI 15420045512030UDI-DIDate23 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number15420045512030 UDI-DI Date2 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK190452 Date23 May 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 54200455DIAGAPTBVRB registered 23 Jun 2026 Active
  • FDA 510(k) K190452 decided 23 May 2019 Active
  • FDA GUDID UDI-DI 15420045512030 listed 2 Jul 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K190452
  2. Listed FDA GUDID 15420045512030
  3. Registered EUDAMED 54200455DIAGAPTBVRB

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  • Withdrawn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 BV Assay EUDAMED
Aptima® GUDID
Generic name
Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Model / Ref / Catalog
PRD-05186 EUDAMED
KIT GUDID
BOX 2 GUDID
ROOM TEMP GUDID
ABV GUDID
100T GUDID
IVD GUDID
ASY-11551 GUDID
Primary DI / UDI-DI
15420045512030
Basic UDI-DI
54200455DIAGAPTBVRB
Direct marketing DI
15420045512030
510(k) Number
FDA product code
NSU, PMN, PQA
EMDN code
W0105011699 Bacteriology - na reagents - other
GMDN term
Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Device class
Class B EUDAMED
Class II GUDID
Regulation number
862.2570, 866.3920, 866.3975
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-05186
GUDID
KIT, BOX 2, ROOM TEMP, ABV, 100T, IVD
Device classEUDAMED
Class B
GUDID
Class II

Device class is stated on each registry's own scale: Class B 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: Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Cleared under the same submission (K190452)

Similar devices in this category

Other devices filed under BACTERIOLOGY - NA REAGENTS - OTHER.

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)