Skip to content

Aptima® BV CALIBRATOR, APTIMA, 100T, IVD

by Hologic

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

Ref PRD-05188

Aptima BV CALIBRATOR, APTIMA, 100T, IVD (PRD-05188) is an in vitro diagnostic device (EU IVDR Class B; FDA Class II; EMDN category standards and calibrators - inf. immunology) 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 15420045512047), 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 15420045512047UDI-DIDate23 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number15420045512047 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 15420045512047 listed 2 Jul 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K190452
  2. Listed FDA GUDID 15420045512047
  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  • Withdrawn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 Calibrator EUDAMED
Aptima® GUDID
Generic name
Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, calibrator
Device name
Aptima BV Assay
Model / Ref / Catalog
PRD-05188, BV CALIBRATOR, APTIMA, 100T, IVD
Primary DI / UDI-DI
15420045512047
Basic UDI-DI
54200455DIAGAPTBVRB
Unit of use DI
05420045512040
510(k) Number
FDA product code
NSU, PQA, PMN
EMDN code
W0105080999 Standards and calibrators - inf. immunology - other
GMDN term
Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, calibrator
Device class
Class B EUDAMED
Class II GUDID
Regulation number
862.2570, 866.3975, 866.3920
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-05188
GUDID
BV CALIBRATOR, APTIMA, 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, calibrator

Cleared under the same submission (K190452)

Similar devices in this category

Other devices filed under STANDARDS AND CALIBRATORS - INFECT. IMMUNOLOGY/NAT.

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)