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 ID00857031002103
NIH Device Record Key64e12d47-8464-4800-af00-5fe2301b056e
Commercial Distribution StatusIn Commercial Distribution
Brand NameC. DIFFICILE TOX A/B II
Version Model Number30397
Company DUNS614218634
Company NameTECHLAB, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100857031002103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLHReagents, Clostridium Difficile Toxin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-03
Device Publish Date2018-10-31

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

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

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