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 ID: 00840733102370
• NIH Device Record Key: 0321aff8-c14e-463a-bca0-55c3040c1013
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revogene Carba C
• Version Model Number: 410500
• Catalog Number: 410500
• Company DUNS: 092815364
• Company Name: MERIDIAN BIOSCIENCE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840733102370 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190275

FDA Product Code

• PMY: System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-23
• Device Publish Date: 2020-07-15

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