GIARDIA/CRYPTOSPORIDIUM CHEK

GUDID 00857031002127

The GIARDIA/CRYPTOSPORIDIUM CHEK test is an enzyme immunoassay for the qualitative detection of Giardia cyst and Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Giardia and/or Cryptosporidium gastrointestinal infections.

TECHLAB, INC.

Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00857031002127
NIH Device Record Keya99b9f71-9b0e-44de-89e1-3fd2ccd5702e
Commercial Distribution StatusIn Commercial Distribution
Brand NameGIARDIA/CRYPTOSPORIDIUM CHEK
Version Model Number30401
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
GS100857031002127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHJCryptosporidium Spp.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-23

On-Brand Devices [GIARDIA/CRYPTOSPORIDIUM CHEK]

00857031002240The GIARDIA/CRYPTOSPORIDIUM CHEK test is an enzyme immunoassay for the qualitative detection of
00857031002127The GIARDIA/CRYPTOSPORIDIUM CHEK test is an enzyme immunoassay for the qualitative detection of

Trademark Results [GIARDIA/CRYPTOSPORIDIUM CHEK]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GIARDIA/CRYPTOSPORIDIUM CHEK
GIARDIA/CRYPTOSPORIDIUM CHEK
78674453 3084001 Live/Registered
TechLab, Inc.
2005-07-20

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