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Diazyme 100148B-CON

by Diazyme Laboratories, Inc.

Ref 100148B-CON

Diazyme 100148B-CON is a device classified as Class C in the EU and Class I in the US made by Diazyme Laboratories, Inc., registered in EUDAMED on 25 Sep 2026 (Basic UDI-DI 0817089023239XL), cleared under FDA 510(k) K141575 on 15 Dec 2014 and listed in FDA GUDID since 21 Jan 2026 (UDI-DI 00817089023239), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K141575

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0817089023239XL Basic UDI-DI 00817089023239UDI-DIDate25 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817089023239 UDI-DI Date21 Jan 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK141575 Date15 Dec 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0817089023239XL registered 25 Sep 2026 Active
  • FDA 510(k) K141575 decided 15 Dec 2014 Active
  • FDA GUDID UDI-DI 00817089023239 listed 21 Jan 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K141575
  2. Listed FDA GUDID 00817089023239
  3. Registered EUDAMED 0817089023239XL

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  • Withdrawn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
Lp-PLA2 Activity Test Controls EUDAMED
Diazyme GUDID
Generic name
Phospholipase A2 IVD, control
Device name
PLAC Test for Lp-PLA2 Activity Control Set
Model / reference
100148B-CON
Primary DI / UDI-DI
00817089023239
Basic UDI-DI
0817089023239XL
510(k) Number
FDA product code
JJX, NOE
EMDN code
W0102152004 Cardiac marker controls
GMDN term
Phospholipase A2 IVD, control
Device class
Class C EUDAMED
Class I GUDID
Regulation number
862.1660, 866.5600
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 C
GUDID
Class I

Device class is stated on each registry's own scale: Class C in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Cleared under the same submission (K141575)

Similar devices in this category

Other devices filed under CARDIAC MARKER CONTROLS.

Other devices from Diazyme Laboratories, Inc.

See all devices from Diazyme Laboratories, Inc. →

Properties

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