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mini VIDAS® 99737

by Biomerieux SA

Ref 99737

mini VIDAS® 99737 is a device classified as IVD General (EU), Class I (US) made by Biomerieux SA, registered in EUDAMED on 15 Sep 2026 (Basic UDI-DI B-03573026140441), cleared under FDA 510(k) K923579 on 12 Feb 1993 and listed in FDA GUDID since 14 Sep 2016 (UDI-DI 03573026140441), active as of 12 Nov 2026. 2 FDA recalls are 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

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K923579

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-03573026140441 Basic UDI-DI 03573026140441UDI-DIDate15 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03573026140441 UDI-DI Date14 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK923579 Date12 Feb 1993DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03573026140441 registered 15 Sep 2026 Active
  • FDA 510(k) K923579 decided 12 Feb 1993 Active
  • FDA GUDID UDI-DI 03573026140441 listed 14 Sep 2016 Listed

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2429-2018 FDA Class II initiated 4 Jan 2018
    • Terminated Z-2428-2018 FDA Class II initiated 4 Jan 2018

    Increase of events affecting performance regarding pump clogging and displacement of the color-coded SPR label (DOT). These performance issues could contribute to erroneous results for any assay performed on the VIDAS and mini VIDAS system due to a decrease of pipetted volume.

Timeline

5 dated events

  1. Cleared FDA 510(k) K923579
  2. Listed FDA GUDID 03573026140441
  3. Recall initiated FDA recalls Z-2429-2018
  4. Recall initiated FDA recalls Z-2428-2018
  5. Registered EUDAMED B-03573026140441

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
mini VIDAS®
Generic name
Fluorescent immunoassay analyser IVD, laboratory
Model / reference
99737
Primary DI / UDI-DI
03573026140441
Basic UDI-DI
B-03573026140441
510(k) Number
FDA product code
JJE
EMDN code
W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
GMDN term
Fluorescent immunoassay analyser IVD, laboratory
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
862.2160
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class I

Device class is stated on each registry's own scale: Class IVD General 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

Category: Fluorescent immunoassay analyser IVD, laboratory

Cleared under the same submission (K923579)

Similar devices in this category

Other devices filed under AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h).

Other devices from Biomerieux SA

See all devices from Biomerieux SA →

Properties

  • Professional testing
  • IVD instrument
  • Prescription use
  • Serial number
Other properties (22, all answered No)