Revogene Carba C 410500

GUDID 00840733102370

The revogene Carba 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 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.

MERIDIAN BIOSCIENCE, INC.

Multiple antimicrobial resistance nucleic acid IVD, nucleic acid technique (NAT)
Primary Device ID00840733102370
NIH Device Record Key0321aff8-c14e-463a-bca0-55c3040c1013
Commercial Distribution StatusIn Commercial Distribution
Brand NameRevogene Carba C
Version Model Number410500
Catalog Number410500
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840733102370 [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 Date2020-07-23
Device Publish Date2020-07-15

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