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.

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• 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