Skip to content

Aptima® KIT, BX 2 (RT) M GEN, 100T, AS, IVD

by Hologic

Ref PRD-03374

Aptima® KIT, BX 2 (RT) M GEN, 100T, AS, IVD (ASY-09408) is a device classified as Class C in the EU and Class II in the US made by Hologic, registered in EUDAMED on 6 May 2026 (Basic UDI-DI 54200455DIAGAPTMGENY9) and listed in FDA GUDID since 25 Jan 2019 (UDI-DI 15420045509153), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number54200455DIAGAPTMGENY9 Basic UDI-DI 15420045509153UDI-DIDate6 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number15420045509153 UDI-DI Date25 Jan 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 54200455DIAGAPTMGENY9 registered 6 May 2026 Active
  • FDA GUDID UDI-DI 15420045509153 listed 25 Jan 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 15420045509153
  2. Registered EUDAMED 54200455DIAGAPTMGENY9

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Aptima Mycoplasma genitalium Assay EUDAMED
Aptima® GUDID
Generic name
Mycoplasma genitalium nucleic acid IVD, kit, nucleic acid technique (NAT)
Model / Ref / Catalog
PRD-03374 EUDAMED
KIT GUDID
BX 2 (RT) M GEN GUDID
100T GUDID
AS GUDID
IVD GUDID
ASY-09408 GUDID
Primary DI / UDI-DI
15420045509153
Basic UDI-DI
54200455DIAGAPTMGENY9
Direct marketing DI
15420045509153
FDA product code
QEP
EMDN code
W010501080302 Urogenital mycoplasma detection by na reagents
GMDN term
Mycoplasma genitalium nucleic acid IVD, kit, nucleic acid technique (NAT)
Device class
Class C EUDAMED
Class II GUDID
Regulation number
866.3393
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-03374
GUDID
KIT, BX 2 (RT) M GEN, 100T, AS, 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: Mycoplasma genitalium nucleic acid IVD, kit, nucleic acid technique (NAT)

Similar devices in this category

Other devices filed under MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS.

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)