TOX A/B QUIK CHEK

GUDID 00857031002257

The TOX A/B QUIK CHEK® test is a rapid immunoassay for detecting Clostridium difficile 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 ID00857031002257
NIH Device Record Keyad9e6006-2bc6-422a-8908-b36b3efc2154
Commercial Distribution StatusIn Commercial Distribution
Brand NameTOX A/B QUIK CHEK
Version Model NumberT5033
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
GS100857031002257 [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 Date2018-09-07
Device Publish Date2018-08-07

On-Brand Devices [TOX A/B QUIK CHEK]

00857031002257The TOX A/B QUIK CHEK® test is a rapid immunoassay for detecting Clostridium difficile toxins A
00857031002042The TOX A/B QUIK CHEK® test is a rapid immunoassay for detecting Clostridium difficile toxins A

Trademark Results [TOX A/B QUIK CHEK]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TOX A/B QUIK CHEK
TOX A/B QUIK CHEK
78567615 3108159 Live/Registered
TechLab, Inc.
2005-02-15

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