FDA.reportPublic FDA data

EZ-SHIGELLA One-Step Shigella species Rapid Test

Primary DI
00083059100952
Brand
EZ-SHIGELLA One-Step Shigella species Rapid Test
Company
BIOMERICA, INC.
Model
1009-15
Device description
The Biomerica Shigella species test is a lateral flow immunoassay for the rapid determination of the presence of Shigella species in human stool samples. The 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
GNBAntisera, All Types, Shigella Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GNBAntisera, All Types, Shigella Spp.Microbiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00083059100952PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00083059100952000830591009520830591009520083059100952

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Shigella species verotoxin 1 & 2 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 verotoxin 1 and/or verotoxin 2 antigens from one or multiple species of Shigella bacteria 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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15060392377854Mast AssureMAST GROUP LIMITEDGNB2022-01-05
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