FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20885380057417
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
CH1145
Catalog number
CH1145
Device description
MONO II RAPID TEST
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
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
50885380057418PackageGS118In Commercial Distribution
20885380057417PrimaryGS10
10885380057410Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538005741850885380057418
2088538005741720885380057417
1088538005741010885380057410

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 Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
25
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10673486014068Teco Diagnostics Infectious Mononucleosis (IM) Latex TestTECO DIAGNOSTICSKTN2026-05-21
20885380183635CARDINAL HEALTHCardinal Health 200, LLCKTN2022-08-29
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