FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885380183638
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
New
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
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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
25
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
false
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
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
20885380183635CARDINAL 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