Revogene® Carba C

Basic Information

• Brand Name: Revogene® Carba C
• Primary DI: 00628055344162
• Version / Model: 410500
• Catalog Number: 410500
• Company Name: Meridian Bioscience Canada Inc
• Labeler DUNS: 204006360
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-21
• Public Version: 4
• Public Version Date: 2021-11-08
• Public Version Status: Update
• Public Device Record Key: dac3b599-7007-4713-a53a-0fe7d596806b
• Distribution End Date: 2021-09-30

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PMY	System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony	Microbiology	866.1640	2
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	862.2570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60673	Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple genes conferring resistance to multiple antimicrobial drugs in multiple types of bacteria present in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT). Genes detected may include, but are not limited to, carbapenemase genes (KPC, NDM, VIM, and OXA), extended spectrum beta-lactamase (ESBL)-encoding genes (e.g., TEM, SHV, IMP, NDM-1 and CTX-M) and/or vancomycin resistance genes (vanA and vanB).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00628055344162	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius