Home GUDID 00742860100017 ImmunoStat G/C 30 Test Kit
Primary DI 00742860100017
Brand ImmunoStat G/C 30 Test Kit
Company Sekisui Diagnostics, LLC
Model 750830
Catalog number 750830
Published 2017-01-10
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name MHI GIARDIA SPP.
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MHI Giardia Spp. Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00742860100017 Primary GS1 0 10742860100014 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00742860100017 00742860100017 742860100017 0742860100017 10742860100014 10742860100014
GMDN Terms# Term, Definition table Term Definition Multiple faecal parasite antigen IVD, kit, rapid ICT, clinical A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple faecal parasites (e.g., Giardia, Entamoeba and Cryptosporidium species) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
Regulatory Flags# DUNS number 966812344 Device count 30 DM exempt false Premarket exempt false 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07290115934298 T-Handle with Pendulum Adaptor PREMIA SPINE LTD MHI 2024-09-03 04048474059557 21-Hydroxylase Autoantibody ELISA DRG Instruments Gesellschaft mit beschränkter Haftung MHI 2023-09-01 04048474034776 Giardia lamblia Antigen (stool) ELISA DRG Instruments Gesellschaft mit beschränkter Haftung MHI 2023-08-29 00840239060594 Giardia/Cryptosporidium Ag (stool) ELISA DRG International Inc MHI 2023-08-26 00840239034779 Giardia lamblia Antigen (stool) ELISA DRG International Inc MHI 2023-08-24 00848838026683 ProSpecT REMEL, INC. MHI 2022-12-23 00083059070699 Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay] BIOMERICA, INC. MHI 2020-07-01 00083059150155 EZ-GIARDIA One-Step Giardia Test BIOMERICA, INC. MHI 2020-07-01 00857031002547 TRI-COMBO PARASITE SCREEN TECHLAB, INC. MHI 2019-05-31 00857031002400 TRI-COMBO PARASITE SCREEN TECHLAB, INC. MHI 2017-10-05 08305900070699 Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay] BIOMERICA, INC. MHI 2016-12-08 08305901501154 EZ-GIARDIA One-Step Giardia Test BIOMERICA, INC. MHI 2016-12-08 00613647000304 Sure-Vue FISHER SCIENTIFIC COMPANY L.L.C. MHI 2016-09-24 00848838026850 NA REMEL, INC. MHI 2016-09-24 00848838026867 NA REMEL, INC. MHI 2016-09-24 00848838026874 NA REMEL, INC. MHI 2016-09-24 00848838026881 NA REMEL, INC. MHI 2016-09-24 00848838026997 NA OXOID LIMITED MHI 2016-09-24 00848838027000 NA OXOID LIMITED MHI 2016-09-24 00848838027017 NA OXOID LIMITED MHI 2016-09-24 20613647000308 Sure-Vue FISHER SCIENTIFIC COMPANY L.L.C. MHI 2016-09-24 00840733101113 MERIFLUOR Cryptosporidium/Giardia MERIDIAN BIOSCIENCE, INC. MHI 2016-09-23 00893038002180 Triage® Alere San Diego, Inc. MHI 2016-09-21 M445MCCCGDFA750 Para-Tect Cryptosporidium/Giardia Direct Fluorescence Assay MEDICAL CHEMICAL CORPORATION MHI 2016-09-20 05391516746328 Trinity Biotech MARDX DIAGNOSTICS, INC. MHI 2016-09-18 05391516746335 Trinity Biotech MARDX DIAGNOSTICS, INC. MHI 2016-09-18 20885380096737 CARDINAL HEALTH Cardinal Health 200, LLC MHI 2016-09-14 50885380096738 CARDINAL HEALTH Cardinal Health 200, LLC MHI 2016-09-14 00857031002028 GIARDIA II TECHLAB, INC. MHI 2016-08-23 00857031002295 GIARDIA II TECHLAB, INC. MHI 2016-08-23