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.
EZ-GIARDIA One-Step Giardia Test - 1501-15
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from the parasitic protozoan Giardia lamblia in a clinical specimen, using an enzyme immunoassay (EIA) method.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: MHI
Device Name: Giardia Spp.
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: MI
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 866.3220
Third Party Flag: N
Medical Specialty: MI
Device IdentifiersDevice Id: 08305901501154
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A