VIDAS® C. difficile GDH

GUDID 03573026444204

VIDAS ® C. difficile GDH is is a qualitative test for use on VIDAS family instruments to detect C. difficile antigen

BIOMERIEUX SA

Clostridium difficile antigen IVD, antibody

• Primary Device ID: 03573026444204
• NIH Device Record Key: bc5238d8-26bc-4ece-bf49-92c00d53af24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIDAS® C. difficile GDH
• Version Model Number: 30125-01
• 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	03573026444204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132010

FDA Product Code

• MCB: ANTIGEN, C. DIFFICILE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-06
• Device Publish Date: 2019-11-19

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