FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50885380096738
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
Rx
false
OTC
true
Sterile
false
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, immunochromatographic test (ICT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple faecal parasite antigens (e.g., Giardia, Entamoeba and Cryptosporidium species) in a clinical specimen, using an immunochromatographic test (ICT) method.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
30
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956038127CARDINAL HEALTHSAN22IAMRASAN22IAMRA2026-10-19
10198956180000CARDINAL HEALTHPUV2KPMHBPUV2KPMHB2026-10-19
10198956268111CARDINAL HEALTHSNECGACSGESNECGACSGE2026-10-19
10198956377967CARDINAL HEALTHSBA56MIMCFSBA56MIMCF2026-10-19
10198956384774CARDINAL HEALTHSVA42LVGLCSVA42LVGLC2026-10-19
10198956390799CARDINAL HEALTHSEYCGEPAZBSEYCGEPAZB2026-10-19
10198956400795CARDINAL HEALTHSOP3MKPCVDSOP3MKPCVD2026-10-19
10198956414815CARDINAL HEALTHSMA41PGEPBSMA41PGEPB2026-10-19
10198956441811CARDINAL HEALTHSCV29VPPCUSCV29VPPCU2026-10-19
10198956462328CARDINAL HEALTHSCV13PPBTESCV13PPBTE2026-10-19
10198956464988CARDINAL HEALTHSOP51XRKKPSOP51XRKKP2026-10-19
10198956499270CARDINAL HEALTHPG33BGMKBPG33BGMKB2026-10-19
10198956499980CARDINAL HEALTH33-2528E33-2528E2026-10-19
10198956506732CARDINAL HEALTHSOP41TPDSFSOP41TPDSF2026-10-19
10198956513587CARDINAL HEALTHSAN33CACHNSAN33CACHN2026-10-19
10198956514874CARDINAL HEALTHSOPOCTKSBBSOPOCTKSBB2026-10-19
10198956516922CARDINAL HEALTHPC23TAAMEPC23TAAME2026-10-19
10198956518964CARDINAL HEALTHSAN40CCAEGSAN40CCAEG2026-10-19
10198956519527CARDINAL HEALTH17-7678I17-7678I2026-10-19
10198956519756CARDINAL HEALTHPO33UEVWBPO33UEVWB2026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00854624006043Giardia/Cryptosporidium Antigen Detection AssayIVD RESEARCH, LLCMHI2026-10-13
00854624006074Giardia Stool Antigen Detection AssayIVD RESEARCH, LLCMHI2026-10-13
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
20885380096737CARDINAL HEALTHCardinal Health 200, LLCMHI2016-09-14