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Ca CA3871

by Randox Laboratories, Ltd.

Ref CA3871

Ca CA3871 is an in vitro diagnostic device (EU IVDD general IVD; FDA Class II; FDA product code CJY, Azo Dye, Calcium) made by Randox Laboratories, Ltd., registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI B-05055273200904), cleared under FDA 510(k) K974607 on 2 Feb 1998 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 05055273200904), active as of 7 Nov 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None, self-declared

Class I: no certifier involved

510(k) K974607

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-05055273200904 Basic UDI-DI 05055273200904UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055273200904 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK974607 Date2 Feb 1998DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05055273200904 registered 28 Oct 2026 Active
  • FDA 510(k) K974607 decided 2 Feb 1998 Active
  • FDA GUDID UDI-DI 05055273200904 listed 16 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

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

Recalls

1 recall · FDA

    • Terminated Z-0839-2019 FDA Class II initiated 4 Dec 2018

    Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calcium reagent results may result in falsely elevated or decreased results to both patient and QC samples.

Timeline

4 dated events

  1. Cleared FDA 510(k) K974607
  2. Listed FDA GUDID 05055273200904
  3. Recall initiated FDA recalls Z-0839-2019
  4. Registered EUDAMED B-05055273200904

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
CALCIUM (Ca) EUDAMED
Ca GUDID
Generic name
Calcium (Ca2+) IVD, reagent
Model / Ref / Catalog
CA3871
Primary DI / UDI-DI
05055273200904
Basic UDI-DI
B-05055273200904
510(k) Number
FDA product code
CJY
EMDN code
W01010303 Calcium
GMDN term
Calcium (Ca2+) IVD, reagent
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.1145
EU registration type
Legacy device (under a directive)
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Calcium (Ca2+) IVD, reagent

Cleared under the same submission (K974607)

Similar devices in this category

Other devices filed under CALCIUM.

Other devices from Randox Laboratories, Ltd.

See all devices from Randox Laboratories, Ltd. →

Properties

  • Single use
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)