Toxigenic C. difficile Direct Test - Sample Prep CDF2-SPD

GUDID G491CDF2SPD0

Vela Operations USA Inc.

Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: G491CDF2SPD0
• NIH Device Record Key: 558d79a6-14a1-4eef-9f46-8a441c2601f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Toxigenic C. difficile Direct Test - Sample Prep
• Version Model Number: 00
• Catalog Number: CDF2-SPD
• Company DUNS: 117416922
• Company Name: Vela Operations USA 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: 888-320-7636
• Email: gb.support@veladx.com
• Phone: 888-320-7636
• Email: gb.support@veladx.com
• Phone: 888-320-7636
• Email: gb.support@veladx.com
• Phone: 888-320-7636
• Email: gb.support@veladx.com
• Phone: 888-320-7636
• Email: gb.support@veladx.com
• Phone: 888-320-7636
• Email: gb.support@veladx.com
• Phone: 888-320-7636
• Email: gb.support@veladx.com
• Phone: 888-320-7636
• Email: gb.support@veladx.com
• Phone: 888-320-7636
• Email: gb.support@veladx.com
• Phone: 888-320-7636
• Email: gb.support@veladx.com
• Phone: 888-320-7636
• Email: gb.support@veladx.com
• Phone: 888-320-7636
• Email: gb.support@veladx.com
• Phone: 888-320-7636
• Email: gb.support@veladx.com
• Phone: 888-320-7636
• Email: gb.support@veladx.com
• Phone: 888-320-7636
• Email: gb.support@veladx.com
• Phone: 888-320-7636
• Email: gb.support@veladx.com
• Phone: 888-320-7636
• Email: gb.support@veladx.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G491CDF2SPD0 [Primary]

FDA Product Code

• OZN: C. Difficile Toxin Gene Amplification Assay

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: 2024-01-26
• Device Publish Date: 2024-01-18

Devices Manufactured by Vela Operations USA Inc.

• G491CDF21 - Toxigenic C. difficile Direct Test: 2024-01-26
• G491CDF2SPD0 - Toxigenic C. difficile Direct Test - Sample Prep: 2024-01-26
• G491CDF2SPD0 - Toxigenic C. difficile Direct Test - Sample Prep: 2024-01-26