C. DIFF QUIK CHEK COMPLETE

GUDID 00857031002158

The TECHLAB® C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting 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. As with other C. difficile tests, results should be considered in conjunction with the patient history.

TECHLAB, INC.

Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00857031002158
NIH Device Record Keycfc778e0-8bf7-42a5-af59-7f477579516b
Commercial Distribution StatusIn Commercial Distribution
Brand NameC. DIFF QUIK CHEK COMPLETE
Version Model NumberT30550C
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
GS100857031002158 [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 [C. DIFF QUIK CHEK COMPLETE]

00857031002387The C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the simultaneou
00857031002370The C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the simultaneou
00857031002158The TECHLAB® C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the s
00857031002059The TECHLAB® C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the s
00857031002554The TECHLAB® C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the s

Trademark Results [C. DIFF QUIK CHEK COMPLETE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
C. DIFF QUIK CHEK COMPLETE
C. DIFF QUIK CHEK COMPLETE
77466957 3597654 Live/Registered
TechLab, Inc.
2008-05-06

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