Home GUDID 00840239034670 Cryptosporidium Antigen (stool) ELISA
Primary DI 00840239034670
Brand Cryptosporidium Antigen (stool) ELISA
Company DRG International Inc
Model EIA-3467
Catalog number EIA-3467
Device description This ELISA is an in vitro immunoassay for the qualitative determination of Cryptosporidium antigen in fecal specimens
Published 2023-08-24
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name MHJ Cryptosporidium Spp.
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MHJ Cryptosporidium Spp. Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840239034670 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00840239034670 00840239034670 840239034670 0840239034670
GMDN Terms# Term, Definition table Term Definition 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 075150847 Device count 1 Premarket exempt true Kit true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 04048474060591 Giardia/Cryptosporidium Ag (stool) ELISA DRG Instruments Gesellschaft mit beschränkter Haftung MHJ 2023-09-01 04048474034677 Cryptosporidium Antigen (stool) ELISA DRG Instruments Gesellschaft mit beschränkter Haftung MHJ 2023-08-29 00083059070637 Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay] BIOMERICA, INC. MHJ 2020-07-01 00857031002547 TRI-COMBO PARASITE SCREEN TECHLAB, INC. MHJ 2019-05-31 00857031002400 TRI-COMBO PARASITE SCREEN TECHLAB, INC. MHJ 2017-10-05 08305900070637 Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay] BIOMERICA, INC. MHJ 2016-12-08 00848838026898 NA REMEL, INC. MHJ 2016-09-24 00848838026904 NA REMEL, INC. MHJ 2016-09-24 00848838026935 NA OXOID LIMITED MHJ 2016-09-24 00893038002180 Triage® Alere San Diego, Inc. MHJ 2016-09-21 M445MCCCGDFA750 Para-Tect Cryptosporidium/Giardia Direct Fluorescence Assay MEDICAL CHEMICAL CORPORATION MHJ 2016-09-20 05391516746342 TrinityBiotech MARDX DIAGNOSTICS, INC. MHJ 2016-09-18 05391516746359 Trinity Biotech MARDX DIAGNOSTICS, INC. MHJ 2016-09-18 00857031002035 CRYPTOSPORIDIUM II TECHLAB, INC. MHJ 2016-08-23 00857031002127 GIARDIA/CRYPTOSPORIDIUM CHEK TECHLAB, INC. MHJ 2016-08-23 00857031002240 GIARDIA/CRYPTOSPORIDIUM CHEK TECHLAB, INC. MHJ 2016-08-23 00857031002301 CRYPTOSPORIDIUM II TECHLAB, INC. MHJ 2016-08-23
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