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PATHFAST TB LAM Ag Control

by PHC Corporation

Ref 30194

PATHFAST TB LAM Ag Control (30194) is an in vitro diagnostic device (EU IVDR Class C; EMDN category controls - inf. immunology) made by Phc Corporation, registered in EUDAMED on 29 May 2026 (Basic UDI-DI 4987595PF1231KXJ), active as of 25 Oct 2026.

Active European Union

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4987595PF1231KXJ Basic UDI-DI 04987595301940UDI-DIDate29 May 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device name
PATHFAST TB LAM Ag
PATHFAST TB LAM Ag Conttrol
Model / reference
30194
Primary DI / UDI-DI
04987595301940
Basic UDI-DI
4987595PF1231KXJ, 4987595PF0231CWP
EMDN code
W0105080899 Controls - inf. immunology - other
Device class
Class C
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
JP-MF-000008516
Authorised representative
PHC Europe B.V. NL-AR-000002692

Similar devices in this category

Other devices filed under CONTROLS - INF. IMMUNOLOGY - OTHER.

Other devices from Phc Corporation

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Properties

  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit YesEUDAMEDNoEUDAMED
  • Professional testing
Other properties (8, all answered No)