FDA.reportPublic FDA data

Henry Schein

Primary DI
20304040024137
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
9004070
Catalog number
9004070
Device description
One Step + Mono Test
Published
2016-09-24
Public version status
Update
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
20304040024137PackageGS140In Commercial Distribution
10304040024130PrimaryGS10
00304040024133Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404002413720304040024137
1030404002413010304040024130
00304040024133003040400241333040400241330304040024133

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
Special Storage Condition, Specify00No
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
20
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040200589Henry Schein570609457060942026-10-06
10304040193843Henry Schein570560657056062026-10-05
10304040193850Henry Schein570560757056072026-10-05
10304040193867Henry Schein570560857056082026-10-05
10304040193874Henry Schein570560957056092026-10-05
10304040193881Henry Schein570561057056102026-10-05
10304040193898Henry Schein570561157056112026-10-05
10304040194109Henry Schein570562257056222026-10-05
10304040194116Henry Schein570562357056232026-10-05
10304040194208Henry Schein570569757056972026-10-05
10304040194215Henry Schein570569857056982026-10-05
10304040194222Henry Schein570569957056992026-10-05
10304040194239Henry Schein570570057057002026-10-05
10304040194246Henry Schein570570157057012026-10-05
10304040194253Henry Schein570570257057022026-10-05
10304040194260Henry Schein570570357057032026-10-05
10304040194277Henry Schein570570457057042026-10-05
10304040194284Henry Schein570570557057052026-10-05
10304040194291Henry Schein570570657057062026-10-05
10304040194307Henry Schein570570757057072026-10-05

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
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