FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20885380183635
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
CH28
Catalog number
CH28
Device description
CH28 - Cardinal Health Mono Cassette
Published
2022-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KTNSystem, test, infectious mononucleosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTNSystem, Test, Infectious MononucleosisImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885380183635PrimaryGS10
10885380183638Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088538018363520885380183635
1088538018363810885380183638

GMDN Terms#

Term, Definition table
TermDefinition
Epstein-Barr virus (EBV) heterophile antibody 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 heterophile antibodies produced in response to Epstein-Barr virus (EBV) 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 to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever. It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
25
Kit
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956182004CARDINAL HEALTHSOPCNEPBSFSOPCNEPBSF2026-07-06
10198956202320CARDINAL HEALTH34-9397L34-9397L2026-07-06
10198956261952CARDINAL HEALTH08-1780F08-1780F2026-07-06
10198956331235CARDINAL HEALTH32-7479R32-7479R2026-07-06
10198956358942CARDINAL HEALTHSEN4LTAGRCSEN4LTAGRC2026-07-06
10198956373068CARDINAL HEALTHSOP53HIOHCSOP53HIOHC2026-07-06
10198956373655CARDINAL HEALTHSANCGANMWCSANCGANMWC2026-07-06
10198956380615CARDINAL HEALTHENDDK4659DENDDK4659D2026-07-06
10198956381124CARDINAL HEALTH34-0950C34-0950C2026-07-06
10198956388789CARDINAL HEALTHSMA11DCWNFSMA11DCWNF2026-07-06
10198956389007CARDINAL HEALTHSEN35ENCFDSEN35ENCFD2026-07-06
10198956393424CARDINAL HEALTHSBADHLPNVCSBADHLPNVC2026-07-06
10198956397361CARDINAL HEALTHSAN29MY87ISAN29MY87I2026-07-06
10198956398689CARDINAL HEALTHSAN3MARCVCSAN3MARCVC2026-07-06
10198956407053CARDINAL HEALTHSOP69TJMSBSOP69TJMSB2026-07-06
10198956414693CARDINAL HEALTHSOP48TKLODSOP48TKLOD2026-07-06
10198956416079CARDINAL HEALTHPN11SF36DPN11SF36D2026-07-06
10198956416482CARDINAL HEALTHSAN11CC26CSAN11CC26C2026-07-06
10198956423077CARDINAL HEALTHPBCGDCBLIPBCGDCBLI2026-07-06
10198956427198CARDINAL HEALTHSBA13SMBTBSBA13SMBTB2026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10673486014068Teco Diagnostics Infectious Mononucleosis (IM) Latex TestTECO DIAGNOSTICSKTN2026-05-21
10885380183638CARDINAL HEALTHCardinal Health 200, LLCKTN2022-08-29
00006136471196Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.KTN2017-10-27
00006136471202Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.KTN2017-10-27
00006136471301Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.KTN2017-10-27
00006136471318Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.KTN2017-10-27
00006136471325Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.KTN2017-10-27
M220P0800163Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KTN2017-02-13
00742860100048MONO, MERIDIAN IMMUNO 25 Test KitSEKISUI DIAGNOSTICS, LLCKTN2017-01-10
20612479202775McKessonMCKESSON MEDICAL-SURGICAL INC.KTN2016-12-09
00722066000311Rapid ResponseBTNX IncKTN2016-10-25
30888277191895MEDLINEMEDLINE INDUSTRIES, INC.KTN2016-10-14
10888277191891MedlineMEDLINE INDUSTRIES, INC.KTN2016-10-14
10304040024130Henry ScheinHENRY SCHEIN, INC.KTN2016-09-24
10763924516299ACCUTEST Rapid Mono TestJANT PHARMACAL CORPORATIONKTN2016-09-24
10859035006191Wampole ColorCard® MonoALERE NORTH AMERICA, LLCKTN2016-09-24
00613647000281Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.KTN2016-09-24
20304040024137Henry ScheinHENRY SCHEIN, INC.KTN2016-09-24
10815845020000Clearview®Alere San Diego, Inc.KTN2016-09-24
10815845020017Acceava®Alere San Diego, Inc.KTN2016-09-24
10815845020062Signify®Alere San Diego, Inc.KTN2016-09-24
10859035006238Acceava® Mono CassetteALERE NORTH AMERICA, LLCKTN2016-09-24
00848838031588NAREMEL, INC.KTN2016-09-24
00848838031601NAREMEL, INC.KTN2016-09-24
00848838065262NAREMEL, INC.KTN2016-09-24
00848838065279NAREMEL, INC.KTN2016-09-24
00848838065385NAREMEL, INC.KTN2016-09-24
00848838076817NAREMEL, INC.KTN2016-09-24
20613647000285Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.KTN2016-09-24
00613647001196Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.KTN2016-09-24