GIARDIA II

GUDID 00857031002295

The GIARDIA II test is an enzyme immunoassay for the qualitative detection of Giardia lamblia cyst antigen in human fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea to determine the presence of G. lamblia gastrointestinal infection. This test can be used for fecal specimens submitted for routine clinical testing from adults or children.

TECHLAB, INC.

Giardia lamblia antigen IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00857031002295
NIH Device Record Keye468ff67-a0c6-47c1-a18e-475b943c1a55
Commercial Distribution StatusIn Commercial Distribution
Brand NameGIARDIA II
Version Model NumberPT5012
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
GS100857031002295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHIGiardia 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 II]

00857031002295The GIARDIA II test is an enzyme immunoassay for the qualitative detection of Giardia lamblia cy
00857031002028The GIARDIA II test is an enzyme immunoassay for the qualitative detection of Giardia lamblia cy

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