FDA.reportPublic FDA data

EZ-GIARDIA One-Step Giardia Test

Primary DI
08305901501154
Brand
EZ-GIARDIA One-Step Giardia Test
Company
BIOMERICA, INC.
Model
1501-15
Device description
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.
Published
2016-12-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MHIGiardia Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHIGiardia Spp.Microbiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08305901501154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08305901501154083059015011548305901501154

GMDN Terms#

Term, Definition table
TermDefinition
Giardia lamblia antigen IVD, kit, enzyme immunoassay (EIA)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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 949 645 2111info@biomerica.com

Regulatory Flags#

DUNS number
067647321
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00083059070330HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT70332020-07-01
08305900010015EZ Detect Fecal Occult Blood Test10012016-12-08
08305900100013EZ Detect Colon Disease Test1000-12016-12-08
00083059010015EZ Detect Fecal Occult Blood Test10012020-07-01
00083059100013EZ Detect Colon Disease Test1000-12020-07-01
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08305900012033Aware Breast Self-Exam Pad12032016-12-07
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08305900070231ACTH [Adrenocorticotropic Hormone] ELISA70232016-12-07
08305900070248Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay]70242016-12-07
08305900070255EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay]70252016-12-07
08305900070309Myoglobin Enzyme Immunoassay Test Kit70302016-12-07
08305900070316TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KIT70312016-12-08
08305900070637Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay]70632016-12-08
08305900070699Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay]70692016-12-08
08305900070781E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay]70782016-12-08
08305901048253EZ-hCG Urine Pregnancy Test1048-252016-12-08

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