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D3 DFA Metapneumovirus Kit

by Diagnostic Hybrids, Inc.

Ref 01-030000Model D3

D3 DFA Metapneumovirus Kit (01-030000) is a device classified as IVD General (EU), Class II (US) made by Diagnostic Hybrids, Inc., registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI B-30014613330516) and listed in FDA GUDID since 15 Sep 2016 (UDI-DI 30014613330516), active as of 7 Nov 2026.

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

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-30014613330516 Basic UDI-DI 30014613330516UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30014613330516 UDI-DI Date15 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-30014613330516 registered 22 Oct 2026 Active
  • FDA GUDID UDI-DI 30014613330516 listed 15 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 30014613330516
  2. Registered EUDAMED B-30014613330516

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
D3 DFA Metapneumovirus Identification Kit EUDAMED
D3 GUDID
Generic name
Human metapneumovirus (hMPV) antigen IVD, kit, fluorescent immunoassay
Device name
DFA Metapneumovirus Identification Kit
Model / Ref / Catalog
D3, 01-030000, DFA Metapneumovirus Kit
Primary DI / UDI-DI
30014613330516
Basic UDI-DI
B-30014613330516
FDA product code
OMG
EMDN code
W0105040617 Human metapneumovirus
GMDN term
Human metapneumovirus (hMPV) antigen IVD, kit, fluorescent immunoassay
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
866.3980
EU registration type
Legacy device (under a directive)
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
D3
01-030000
GUDID
DFA Metapneumovirus Kit
Device classEUDAMED
Class IVD General
GUDID
Class II

Device class is stated on each registry's own scale: Class IVD General 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: Human metapneumovirus (hMPV) antigen IVD, kit, fluorescent immunoassay

Similar devices in this category

Other devices filed under OTHER VIROLOGY ANTIGEN/ANTIBODY DETECTION.

Other devices from Diagnostic Hybrids, Inc.

See all devices from Diagnostic Hybrids, Inc. →

Properties

  • Single use
  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (15, all answered No)