EZ-GIARDIA One-Step Giardia Test

GUDID 08305901501154

The Biomerica Giardia test is a rapid chromatographic immunoassay for the qualitative detection of Giardia antigens in human stool samples. The In Vitro test is intended for professional use only.

BIOMERICA, INC.

Giardia lamblia antigen IVD, kit, enzyme immunoassay (EIA)
Primary Device ID08305901501154
NIH Device Record Key2af9f532-223c-469f-b495-f3dbde04fe97
Commercial Distribution Discontinuation2020-07-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEZ-GIARDIA One-Step Giardia Test
Version Model Number1501-15
Company DUNS067647321
Company NameBIOMERICA, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108305901501154 [Primary]

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 Date2021-09-02
Device Publish Date2016-12-08

On-Brand Devices [EZ-GIARDIA One-Step Giardia Test]

00083059150155The Biomerica Giardia test is a rapid chromatographic immunoassay for the qualitative detection
08305901501154The Biomerica Giardia test is a rapid chromatographic immunoassay for the qualitative detection

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