Revogene® Carba C 410500

GUDID 00628055344162

The Revogene® Carba C assay, performed on the Revogene® instrument, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The test utilizes automated real-time Polymerase Chain Reaction (PCR). The Revogene Carba C assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. A negative Revogene Carba C assay result does not preclude the presence of other resistance mechanisms. The Revogene Carba C assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The identification of a blaIMP, blaNDM or blaVIM metallo-B-lactamase gene (i.e., the genes that encode the IMP, NDM and VIM metallo-B-lactamases, respectively) may be used as an aid to clinicians in determining appropriate therapeutic strategies for patients with known or suspected carbapenem non-susceptible infections.

Meridian Bioscience Canada Inc

Multiple antimicrobial resistance nucleic acid IVD, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00628055344162
NIH Device Record Keydac3b599-7007-4713-a53a-0fe7d596806b
Commercial Distribution StatusIn Commercial Distribution
Brand NameRevogene® Carba C
Version Model Number410500
Catalog Number410500
Company DUNS204006360
Company NameMeridian Bioscience Canada 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

Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100628055344162 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PMYSystem, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-29
Device Publish Date2019-10-21

Devices Manufactured by Meridian Bioscience Canada Inc

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00628055344162 - Revogene® Carba C2019-10-29The Revogene® Carba C assay, performed on the Revogene® instrument, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The test utilizes automated real-time Polymerase Chain Reaction (PCR). The Revogene Carba C assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. A negative Revogene Carba C assay result does not preclude the presence of other resistance mechanisms. The Revogene Carba C assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The identification of a blaIMP, blaNDM or blaVIM metallo-B-lactamase gene (i.e., the genes that encode the IMP, NDM and VIM metallo-B-lactamases, respectively) may be used as an aid to clinicians in determining appropriate therapeutic strategies for patients with known or suspected carbapenem non-susceptible infections.
00628055344162 - Revogene® Carba C2019-10-29 The Revogene® Carba C assay, performed on the Revogene® instrument, is a qualitative in vitro diagnostic test designed for the
00628055344179 - Revogene® Strep A2019-10-29 The Revogene® Strep A assay, performed on the Revogene® instrument, is an automated, qualitative in vitro diagnostic test that

Trademark Results [Revogene]

Mark Image

Registration | Serial
Company
Trademark
Application Date
REVOGENE
REVOGENE
87514391 5784546 Live/Registered
Genepoc Inc.
2017-07-03

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