C. DIFFICILE TOX A/B II

GUDID 00857031002103

The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile. It can be used to detect toxins A and B in fecal specimens from persons suspected of having C. difficile disease. 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, enzyme immunoassay (EIA)

• Primary Device ID: 00857031002103
• NIH Device Record Key: 64e12d47-8464-4800-af00-5fe2301b056e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C. DIFFICILE TOX A/B II
• Version Model Number: 30397
• 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	00857031002103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003306

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: 2018-12-03
• Device Publish Date: 2018-10-31

On-Brand Devices [C. DIFFICILE TOX A/B II]

• 00857031002424: The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B
• 00857031002103: The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B
• 00857031002219: The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B
• 00857031002431: The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B
• 00857031002646: The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B