VIDAS® C. difficile Toxin A & B

GUDID 03573026229146

The VIDAS ® C. difficile Toxin A & B is a test for use on VIDAS family instruments for the qualitative detection of Clostridium difficile toxin A and B in stool specimens

BIOMERIEUX SA

Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 03573026229146
• NIH Device Record Key: d422473d-7b74-4254-8f22-116dc9c52595
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIDAS® C. difficile Toxin A & B
• Version Model Number: 30118-01
• 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 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026229146 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080931

FDA Product Code

• LLH: REAGENTS, CLOSTRIDIUM DIFFICILE TOXIN

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: 2019-11-18
• Device Publish Date: 2019-11-08

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