C. DIFFICILE TOXIN ANTITOXIN KIT

GUDID 00857031002066

The Clostridium difficile Toxin/Antitoxin Kit is intended for use in conjunction with the tissue culture cytotoxicity assay for the confirmation of Clostridium difficile toxin in patient specimens. The kit includes a toxin control reagent and a specific C. difficile antitoxin for use in a tissue culture assay. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history.

TECHLAB, INC.

Clostridium difficile antigen IVD, kit, cell culture assay

• Primary Device ID: 00857031002066
• NIH Device Record Key: 9c3ef5f9-0d22-4dfd-86f2-a548247c03c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C. DIFFICILE TOXIN ANTITOXIN KIT
• Version Model Number: T5000
• Company DUNS: 614218634
• Company Name: TECHLAB, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857031002066 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923463

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: 2020-02-03
• Device Publish Date: 2020-01-24

Devices Manufactured by TECHLAB, INC.

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