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mini VIDAS® 99737R

by Biomerieux SA

mini VIDAS® 99737R is a Class I device made by Biomerieux SA, cleared under FDA 510(k) K923579 on 12 Feb 1993 and listed in FDA GUDID since 14 Sep 2016 (UDI-DI 03573026152499), active as of 12 Nov 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K923579

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03573026152499 UDI-DI Date14 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK923579 Date12 Feb 1993DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K923579 decided 12 Feb 1993 Active
  • FDA GUDID UDI-DI 03573026152499 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

4 dated events

  1. Cleared FDA 510(k) K923579
  2. Listed FDA GUDID 03573026152499
  3. Recall initiated FDA recalls Z-2429-2018
  4. Recall initiated FDA recalls Z-2428-2018

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
mini VIDAS®
Generic name
Fluorescent immunoassay analyser IVD, laboratory
Model / reference
99737R
Primary DI / UDI-DI
03573026152499
510(k) Number
FDA product code
JJE
GMDN term
Fluorescent immunoassay analyser IVD, laboratory
Device class
Class I
Regulation number
862.2160
GUDID distribution status
In Commercial Distribution

Related devices

Category: Fluorescent immunoassay analyser IVD, laboratory

Cleared under the same submission (K923579)

Similar devices

Other devices filed under FDA product code JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use).

Other devices from Biomerieux SA

See all devices from Biomerieux SA →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)