C. DIFFICILE TOX-B TEST

GUDID 00857031002073

The C. DIFFICILE TOX-B TEST is intended for use in conjunction with the tissue culture cytotoxicity assay for the detection of C. difficile toxin B in patient specimens. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with patient history.

TECHLAB, INC.

Clostridium difficile antigen IVD, kit, cell culture assay

• Primary Device ID: 00857031002073
• NIH Device Record Key: 4c721a1c-045b-4f1a-abe9-3dc80975a98f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C. DIFFICILE TOX-B TEST
• Version Model Number: 30399U
• 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	00857031002073 [Primary]

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

On-Brand Devices [C. DIFFICILE TOX-B TEST]

• 00857031002264: The C. DIFFICILE TOX-B TEST is intended for use in conjunction with the tissue culture cytotoxic
• 00857031002073: The C. DIFFICILE TOX-B TEST is intended for use in conjunction with the tissue culture cytotoxic