illumigene C. difficile 280050

GUDID 00840733101168

The illumigene C. difficile DNA amplification assay, performed on the illumipro-10, is a qualitative in vitro diagnostic test for the direct detection of toxigenic C. difficile in human stool specimens from pediatric and adult patients suspected of having Clostridium difficile-associated disease (CDAD). The illumigene C. difficile assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect the pathogenicity locus (PaLoc) of toxigenic Clostridium difficile. The Clostridium difficile PaLoc is a gene segment present in all known toxigenic C. difficile strains. The C. difficile PaLoc codes for both the Toxin A gene (tcdA) and the Toxin B gene (tcdB), has conserved border regions, and is found at the same site on the C. difficile genome for all toxigenic strains. The illumigene C. difficile assay detects the PaLoc by targeting a partial DNA fragment on the Toxin A gene. The tcdA target region was selected as an intact region remaining in all known A+B+ and A-B+ toxinotypes.

MERIDIAN BIOSCIENCE, INC.

Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00840733101168
NIH Device Record Keyb6f56a32-cee5-4b7a-91be-1b6580702f66
Commercial Distribution StatusIn Commercial Distribution
Brand Nameillumigene C. difficile
Version Model Number280050
Catalog Number280050
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

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840733101168 [Primary]

FDA Product Code

OMNC. Difficile Nucleic Acid Amplification Test Assay

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-23

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