VIDAS® C. difficile GDH

GUDID 03573026444204

VIDAS ® C. difficile GDH is is a qualitative test for use on VIDAS family instruments to detect C. difficile antigen

BIOMERIEUX SA

Clostridium difficile antigen IVD, antibody
Primary Device ID03573026444204
NIH Device Record Keybc5238d8-26bc-4ece-bf49-92c00d53af24
Commercial Distribution StatusIn Commercial Distribution
Brand NameVIDAS® C. difficile GDH
Version Model NumberVIDAS® C. difficile GDH
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103573026444204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCBANTIGEN, C. DIFFICILE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-27
Device Publish Date2019-11-19

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