Toxigenic C. difficile Direct Test 300786

GUDID G491CDF21

Vela Operations USA Inc.

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• Primary Device ID: G491CDF21
• NIH Device Record Key: ed2f2e9b-54d2-405d-9494-8e09186b7606
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Toxigenic C. difficile Direct Test
• Version Model Number: 01
• Catalog Number: 300786
• 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	G491CDF20 [Primary]
HIBCC	G491CDF21 [Package]; Contains: G491CDF20; Package: EA [10 Units]; In Commercial Distribution

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