VIDAS 3

GUDID 03573026613839

VIDAS 3 V1.3.2 PATCH

BIOMERIEUX SA

Fluorescent immunoassay analyser IVD, laboratory, automated Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory
Primary Device ID03573026613839
NIH Device Record Keyb5d9781b-d1e5-4a88-8a3d-f18b9fdf0e72
Commercial Distribution StatusIn Commercial Distribution
Brand NameVIDAS 3
Version Model Number1.3.2
Company DUNS276816717
Company NameBIOMERIEUX SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103573026613839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-24
Device Publish Date2020-02-14

On-Brand Devices [VIDAS 3]

03573026613839VIDAS 3 V1.3.2 PATCH
03573026608866VIDAS 3 V1.3 DVD SW UPDATE

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