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Aptima® CMV, CALIBRATOR KIT, APTIMA, IVD

by Hologic

Ref PRD-05075

Aptima® CMV, CALIBRATOR KIT, APTIMA, IVD (PRD-05075) 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 54200455DIAGAPTCMVAP), cleared under FDA 510(k) K243935 on 17 Jan 2025 and listed in FDA GUDID since 1 Jun 2022 (UDI-DI 15420045514577), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K243935

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number54200455DIAGAPTCMVAP Basic UDI-DI 15420045514577UDI-DIDate27 May 2026RegisteredStatusActive
United StatesFDA 510(k) GUDID from GUDID NumberK243935 Date17 Jan 2025IssuedStatusActive
United StatesGUDID listing GUDID Number15420045514577 UDI-DI Date1 Jun 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 54200455DIAGAPTCMVAP registered 27 May 2026 Active
  • FDA 510(k) K243935 decided 17 Jan 2025 Active
  • FDA GUDID UDI-DI 15420045514577 listed 1 Jun 2022 Listed

Timeline

3 dated events

  1. Listed FDA GUDID 15420045514577
  2. Cleared FDA 510(k) K243935
  3. Registered EUDAMED 54200455DIAGAPTCMVAP

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  • Withdrawn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 CMV Quant Assay Calibrator EUDAMED
Aptima® GUDID
Generic name
Cytomegalovirus (CMV) nucleic acid IVD, calibrator
Device name
Aptima CMV Quant Assay
Model / Ref / Catalog
PRD-05075, CMV, CALIBRATOR KIT, APTIMA, IVD
Primary DI / UDI-DI
15420045514577
Basic UDI-DI
54200455DIAGAPTCMVAP
Unit of use DI
05420045514570
510(k) Number
FDA product code
PAB
EMDN code
W0105080908 Standards and calibrators for all infections/ nat
GMDN term
Cytomegalovirus (CMV) nucleic acid IVD, calibrator
Device class
Class C EUDAMED
Class II GUDID
Regulation number
866.3180
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-05075
GUDID
CMV, CALIBRATOR KIT, APTIMA, 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: Cytomegalovirus (CMV) nucleic acid IVD, calibrator

Cleared under the same submission (K243935)

Cleared under the same submission (P210029)

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)