FDA.reportPublic FDA data

EZ-GIARDIA One-Step Giardia Test

Primary DI
00083059150155
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
2020-07-01
Public version status
New
Distribution status
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
00083059150155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00083059150155000830591501550830591501550083059150155

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
Primary DIBrandModelCatalogPublished
00083059070835Hp Detect Stool Antigen ELISA708370832024-01-08
08305900070330HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT70332016-12-07
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
08305901007151EZ-SALMONELLA One-Step Salmonella species Rapid Test1007-152016-12-08
00083059100754EZ-SALMONELLA One-Step Salmonella species Rapid Test1007-152020-07-01
08305900012033Aware Breast Self-Exam Pad12032016-12-07
08305900070040GAP®-IgG (Gastritis and Peptic Ulcer Test)70042016-12-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115934298T-Handle with Pendulum AdaptorPREMIA SPINE LTDMHI2024-09-03
0404847405955721-Hydroxylase Autoantibody ELISA DRG Instruments Gesellschaft mit beschränkter HaftungMHI2023-09-01
04048474034776Giardia lamblia Antigen (stool) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungMHI2023-08-29
00840239060594Giardia/Cryptosporidium Ag (stool) ELISA DRG International IncMHI2023-08-26
00840239034779Giardia lamblia Antigen (stool) ELISA DRG International IncMHI2023-08-24
00848838026683ProSpecTREMEL, INC.MHI2022-12-23
00083059070699Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.MHI2020-07-01
00857031002547TRI-COMBO PARASITE SCREENTECHLAB, INC.MHI2019-05-31
00857031002400TRI-COMBO PARASITE SCREENTECHLAB, INC.MHI2017-10-05
00742860100017ImmunoStat G/C 30 Test KitSEKISUI DIAGNOSTICS, LLCMHI2017-01-10
08305900070699Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.MHI2016-12-08
08305901501154EZ-GIARDIA One-Step Giardia TestBIOMERICA, INC.MHI2016-12-08
00613647000304Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.MHI2016-09-24
00848838026850NAREMEL, INC.MHI2016-09-24
00848838026867NAREMEL, INC.MHI2016-09-24
00848838026874NAREMEL, INC.MHI2016-09-24
00848838026881NAREMEL, INC.MHI2016-09-24
00848838026997NAOXOID LIMITEDMHI2016-09-24
00848838027000NAOXOID LIMITEDMHI2016-09-24
00848838027017NAOXOID LIMITEDMHI2016-09-24
20613647000308Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.MHI2016-09-24
00840733101113MERIFLUOR Cryptosporidium/GiardiaMERIDIAN BIOSCIENCE, INC.MHI2016-09-23
00893038002180Triage®Alere San Diego, Inc.MHI2016-09-21
M445MCCCGDFA750Para-Tect Cryptosporidium/Giardia Direct Fluorescence AssayMEDICAL CHEMICAL CORPORATIONMHI2016-09-20
05391516746328Trinity BiotechMARDX DIAGNOSTICS, INC.MHI2016-09-18
05391516746335Trinity BiotechMARDX DIAGNOSTICS, INC.MHI2016-09-18
20885380096737CARDINAL HEALTHCardinal Health 200, LLCMHI2016-09-14
50885380096738CARDINAL HEALTHCardinal Health 200, LLCMHI2016-09-14
00857031002028GIARDIA IITECHLAB, INC.MHI2016-08-23
00857031002295GIARDIA IITECHLAB, INC.MHI2016-08-23