FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20885380096737
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
CH6830
Catalog number
CH6830
Device description
CRYPTO GIARDIA KIT
Published
2016-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
MHIGIARDIA SPP.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHIGiardia Spp.Microbiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380096738PackageGS112In Commercial Distribution
20885380096737PrimaryGS10
10885380096730Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538009673850885380096738
2088538009673720885380096737
1088538009673010885380096730

GMDN Terms#

Term, Definition table
TermDefinition
Multiple faecal parasite antigen IVD, kit, rapid ICT, clinicalA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
30
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956101524CARDINAL HEALTHSOP73TKAPBSOP73TKAPB2026-06-03
10198956177055CARDINAL HEALTHPBCGPVWTIPBCGPVWTI2026-06-03
10198956198456CARDINAL HEALTHSMA69OMBFFSMA69OMBFF2026-06-03
10198956309012CARDINAL HEALTHMAT534227DMAT534227D2026-06-03
10198956320086CARDINAL HEALTHSOP73HESJESOP73HESJE2026-06-03
10198956320123CARDINAL HEALTHPV63ADSTIPV63ADSTI2026-06-03
10198956328938CARDINAL HEALTHSCV3ICVJCDSCV3ICVJCD2026-06-03
10198956332638CARDINAL HEALTHSOP52AC52ASOP52AC52A2026-06-03
10198956334915CARDINAL HEALTHSANCGCARIFSANCGCARIF2026-06-03
10198956346369CARDINAL HEALTHSCVCGEPSBBSCVCGEPSBB2026-06-03
10198956348950CARDINAL HEALTHSBA4LMNGRESBA4LMNGRE2026-06-03
10198956362147CARDINAL HEALTHSOP73KPIODSOP73KPIOD2026-06-03
10198956363922CARDINAL HEALTHSEN41FPVVDSEN41FPVVD2026-06-03
10198956371040CARDINAL HEALTHSOP56KAOSHSOP56KAOSH2026-06-03
10198956372641CARDINAL HEALTHSOP43ARANBSOP43ARANB2026-06-03
10198956379008CARDINAL HEALTHSOP45CAGHISOP45CAGHI2026-06-03
10198956385689CARDINAL HEALTHSOP44TKSVCSOP44TKSVC2026-06-03
10198956386099CARDINAL HEALTHSMA56IVRCBSMA56IVRCB2026-06-03
10198956390928CARDINAL HEALTHSBA54LCTCCSBA54LCTCC2026-06-03
10198956391437CARDINAL HEALTHSOT42SPMSESOT42SPMSE2026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115934298T-Handle with Pendulum AdaptorPREMIA SPINE LTDMHI2024-09-03
0404847405955721-Hydroxylase Autoantibody ELISA DRG Instruments Gesellschaft mit beschränkter HaftungMHI2023-09-01
04048474034776Giardia lamblia Antigen (stool) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungMHI2023-08-29
00840239060594Giardia/Cryptosporidium Ag (stool) ELISA DRG International IncMHI2023-08-26
00840239034779Giardia lamblia Antigen (stool) ELISA DRG International IncMHI2023-08-24
00848838026683ProSpecTREMEL, INC.MHI2022-12-23
00083059070699Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.MHI2020-07-01
00083059150155EZ-GIARDIA One-Step Giardia TestBIOMERICA, INC.MHI2020-07-01
00857031002547TRI-COMBO PARASITE SCREENTECHLAB, INC.MHI2019-05-31
00857031002400TRI-COMBO PARASITE SCREENTECHLAB, INC.MHI2017-10-05
00742860100017ImmunoStat G/C 30 Test KitSEKISUI DIAGNOSTICS, LLCMHI2017-01-10
08305900070699Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.MHI2016-12-08
08305901501154EZ-GIARDIA One-Step Giardia TestBIOMERICA, INC.MHI2016-12-08
00613647000304Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.MHI2016-09-24
00848838026850NAREMEL, INC.MHI2016-09-24
00848838026867NAREMEL, INC.MHI2016-09-24
00848838026874NAREMEL, INC.MHI2016-09-24
00848838026881NAREMEL, INC.MHI2016-09-24
00848838026997NAOXOID LIMITEDMHI2016-09-24
00848838027000NAOXOID LIMITEDMHI2016-09-24
00848838027017NAOXOID LIMITEDMHI2016-09-24
20613647000308Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.MHI2016-09-24
00840733101113MERIFLUOR Cryptosporidium/GiardiaMERIDIAN BIOSCIENCE, INC.MHI2016-09-23
00893038002180Triage®Alere San Diego, Inc.MHI2016-09-21
M445MCCCGDFA750Para-Tect Cryptosporidium/Giardia Direct Fluorescence AssayMEDICAL CHEMICAL CORPORATIONMHI2016-09-20
05391516746328Trinity BiotechMARDX DIAGNOSTICS, INC.MHI2016-09-18
05391516746335Trinity BiotechMARDX DIAGNOSTICS, INC.MHI2016-09-18
50885380096738CARDINAL HEALTHCardinal Health 200, LLCMHI2016-09-14
00857031002028GIARDIA IITECHLAB, INC.MHI2016-08-23
00857031002295GIARDIA IITECHLAB, INC.MHI2016-08-23