ImmunoCard C. difficile GDH 716050

GUDID 00840733101793

ImmunoCard C. difficile GDH is a rapid qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile infection (CDI). This test does not distinguish between toxigenic and non-toxigenic strains of C. difficile. Samples from patients that produce positive results with this test must be further tested with an assay designed to detect toxigenic C. difficile strains and assist with the diagnosis of CDI.

MERIDIAN BIOSCIENCE, INC.

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Primary Device ID00840733101793
NIH Device Record Key29220b2c-8ecf-4671-a383-aa2fa2018adf
Commercial Distribution StatusIn Commercial Distribution
Brand NameImmunoCard C. difficile GDH
Version Model Number716050
Catalog Number716050
Company DUNS092815364
Company NameMERIDIAN BIOSCIENCE, INC.
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 Usetrue
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

Customer Support Contacts

Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840733101793 [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 Date2020-08-19
Device Publish Date2020-08-11

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