ARGENE® ADENOVIRUS R-gene KIT US

GUDID 03573026403997

ADENOVIRUS R-gene® KIT US is a RT-PCR test is to aid in the diagnosis of respiratory Adenovirus infection in humans in conjunction with other clinical and laboratory findings.

BIOMERIEUX SA

Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 03573026403997
• NIH Device Record Key: 01c26d7a-4b02-44de-83b7-7e0c07c9bdb9
• Commercial Distribution Discontinuation: 2018-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ARGENE® ADENOVIRUS R-gene KIT US
• Version Model Number: 69-010B-US
• Company DUNS: 276816717
• Company Name: BIOMERIEUX SA
• 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: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -31 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026403997 [Primary]

FDA Product Code

• OCC: Respiratory Virus Panel Nucleic Acid Assay System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-23
• Device Publish Date: 2016-10-17

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