Skip to content

Dade® PFA Trigger Solution 10445701

by Siemens Healthcare Diagnostics Products Ltd

Ref 10445701Model IVDR_27_MAR EB_A_REAG_PFA_TrigSol

Dade® PFA Trigger Solution 10445701 (B4170-50) is a device classified as Class A in the EU and Class II in the US made by Siemens Healthcare Diagnostics Products Ltd, registered in EUDAMED on 25 Jun 2026 (Basic UDI-DI 0405686902013US), cleared under FDA 510(k) K060489 on 21 Jul 2006 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00842768003691), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K060489

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686902013US Basic UDI-DI 00842768003691UDI-DIDate25 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842768003691 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK060489 Date21 Jul 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0405686902013US registered 25 Jun 2026 Active
  • FDA 510(k) K060489 decided 21 Jul 2006 Active
  • FDA GUDID UDI-DI 00842768003691 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K060489
  2. Listed FDA GUDID 00842768003691
  3. Registered EUDAMED 0405686902013US

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  • Withdrawn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
Dade PFA Trigger Solution EUDAMED
Dade® PFA Trigger Solution GUDID
Generic name
Platelet aggregation study IVD, reagent
Device name
IVDR_27_MAR EB_A_REAG_PFA_TrigSol
Model / Ref / Catalog
10445701, IVDR_27_MAR EB_A_REAG_PFA_TrigSol, B4170-50
Primary DI / UDI-DI
00842768003691
Basic UDI-DI
0405686902013US
Unit of use DI
00842768019791
510(k) Number
FDA product code
JOZ
EMDN code
W0103020499 Primary hemostasis/platelet factors - other
GMDN term
Platelet aggregation study IVD, reagent
Device class
Class A EUDAMED
Class II GUDID
Regulation number
864.5700
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class II

Device class is stated on each registry's own scale: Class A 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: Platelet aggregation study IVD, reagent

Cleared under the same submission (K060489)

Similar devices in this category

Other devices filed under PLATELET FACTORS.

Other devices from Siemens Healthcare Diagnostics Products Ltd

See all devices from Siemens Healthcare Diagnostics Products Ltd →

Properties

  • Reagent
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)