Revogene GBS LB 410200

GUDID 00840733102363

The Revogene GBS LB assay performed on the Revogene Instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 18-24 hour LIM Broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women. The Revogene GBS LB assay utilizes Automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome. The Revogene GBS LB assay is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. it is not intended to diagnose or monitor treatment of GBS infection. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.

MERIDIAN BIOSCIENCE, INC.

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• Primary Device ID: 00840733102363
• NIH Device Record Key: cf6a1293-f9fd-45c9-8256-9bb9b344460e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revogene GBS LB
• Version Model Number: 410200
• Catalog Number: 410200
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840733102363 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170557

FDA Product Code

• NJR: Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

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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