FDA.reportPublic FDA data

Cryptosporidium Stool Antigen Detection Assay

Primary DI
00854624006036
Brand
Cryptosporidium Stool Antigen Detection Assay
Company
IVD RESEARCH, LLC
Model
CP2-96
Device description
This ELISA is an in vitro immunoassay for the qualitative determination of Cryptosporidium antigen in fecal specimens.
Published
2026-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00854624006036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854624006036008546240060368546240060360854624006036

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.

Regulatory Flags#

DUNS number
965482789
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854624006043Giardia/Cryptosporidium Antigen Detection AssayCP/GL-962026-10-13
00854624006074Giardia Stool Antigen Detection AssayGL2-962026-10-13
00854624006005Crypto/Giardia Human Fecal Direct Fluorescent Antigen Detection KitC/G-DFAC/G-DFA2016-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00854624006043Giardia/Cryptosporidium Antigen Detection AssayIVD RESEARCH, LLCMHJ2026-10-13
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
08305900070637Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.MHJ2016-12-08
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