FDA.reportPublic FDA data

Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay]

Primary DI
08305900070637
Brand
Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay]
Company
BIOMERICA, INC.
Model
7063
Device description
The Biomerica Cryptosporidium ELISA is intended for the qualitative detection of Cryptosporidium-specific antigen (CSA) in fecal specimens. This assay is intended for in vitro diagnostic 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
MHJCryptosporidium Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHJCryptosporidium Spp.Microbiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08305900070637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08305900070637083059000706378305900070637

GMDN Terms#

Term, Definition table
TermDefinition
Cryptosporidium species 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 species of the parasitic protozoan Cryptosporidium 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
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
08305901501154EZ-GIARDIA One-Step Giardia Test1501-152016-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048474060591Giardia/Cryptosporidium Ag (stool) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungMHJ2023-09-01
04048474034677Cryptosporidium Antigen (stool) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungMHJ2023-08-29
00840239034670Cryptosporidium Antigen (stool) ELISA DRG International IncMHJ2023-08-24
00083059070637Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.MHJ2020-07-01
00857031002547TRI-COMBO PARASITE SCREENTECHLAB, INC.MHJ2019-05-31
00857031002400TRI-COMBO PARASITE SCREENTECHLAB, INC.MHJ2017-10-05
00848838026898NAREMEL, INC.MHJ2016-09-24
00848838026904NAREMEL, INC.MHJ2016-09-24
00848838026935NAOXOID LIMITEDMHJ2016-09-24
00893038002180Triage®Alere San Diego, Inc.MHJ2016-09-21
M445MCCCGDFA750Para-Tect Cryptosporidium/Giardia Direct Fluorescence AssayMEDICAL CHEMICAL CORPORATIONMHJ2016-09-20
05391516746342TrinityBiotechMARDX DIAGNOSTICS, INC.MHJ2016-09-18
05391516746359Trinity BiotechMARDX DIAGNOSTICS, INC.MHJ2016-09-18
00857031002035CRYPTOSPORIDIUM IITECHLAB, INC.MHJ2016-08-23
00857031002127GIARDIA/CRYPTOSPORIDIUM CHEKTECHLAB, INC.MHJ2016-08-23
00857031002240GIARDIA/CRYPTOSPORIDIUM CHEKTECHLAB, INC.MHJ2016-08-23
00857031002301CRYPTOSPORIDIUM IITECHLAB, INC.MHJ2016-08-23