Home GUDID 10885380183638 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 Code Name KTN System, test, infectious mononucleosis
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KTN System, Test, Infectious Mononucleosis Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20885380183635 Primary GS1 0 10885380183638 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20885380183635 20885380183635 10885380183638 10885380183638
GMDN Terms# Term, Definition table Term Definition Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical A 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 Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 30 Degrees Celsius
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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published M220P0800163 Pro Advantage NATIONAL DISTRIBUTION & CONTRACTING, INC. KTN 2017-02-13 00742860100048 MONO, MERIDIAN IMMUNO 25 Test Kit SEKISUI DIAGNOSTICS, LLC KTN 2017-01-10 20612479202775 McKesson MCKESSON MEDICAL-SURGICAL INC. KTN 2016-12-09 00722066000311 Rapid Response BTNX Inc KTN 2016-10-25 30888277191895 MEDLINE MEDLINE INDUSTRIES, INC. KTN 2016-10-14 10888277191891 Medline MEDLINE INDUSTRIES, INC. KTN 2016-10-14 20304040024137 Henry Schein HENRY SCHEIN, INC. KTN 2016-09-24 10815845020000 Clearview® ALERE SAN DIEGO, INC. KTN 2016-09-24 10815845020017 Acceava® ALERE SAN DIEGO, INC. KTN 2016-09-24 10815845020062 Signify® ALERE SAN DIEGO, INC. KTN 2016-09-24 10859035006238 Acceava® Mono Cassette ALERE NORTH AMERICA, LLC KTN 2016-09-24 00848838031588 NA REMEL, INC. KTN 2016-09-24 00848838031601 NA REMEL, INC. KTN 2016-09-24 00848838065262 NA REMEL, INC. KTN 2016-09-24 00848838065279 NA REMEL, INC. KTN 2016-09-24 00848838065385 NA REMEL, INC. KTN 2016-09-24 00848838076817 NA REMEL, INC. KTN 2016-09-24 20613647000285 Sure-Vue FISHER SCIENTIFIC COMPANY L.L.C. KTN 2016-09-24 00613647001196 Sure-Vue FISHER SCIENTIFIC COMPANY L.L.C. KTN 2016-09-24 00613647001202 Sure-Vue FISHER SCIENTIFIC COMPANY L.L.C. KTN 2016-09-24 00613647001301 Sure-Vue FISHER SCIENTIFIC COMPANY L.L.C. KTN 2016-09-24 00613647001318 Sure-Vue FISHER SCIENTIFIC COMPANY L.L.C. KTN 2016-09-24 00613647001325 Sure-Vue FISHER SCIENTIFIC COMPANY L.L.C. KTN 2016-09-24 00304040001387 Henry Schein OneStep HENRY SCHEIN, INC. KTN 2016-09-24 08426950344773 Color Mono 50 TESTS BIOKIT, S.A. KTN 2016-09-23 10743816000921 BioSign® Mono card PRINCETON BIOMEDITECH CORPORATION KTN 2016-09-23 10743816000938 BioSign® Mono card PRINCETON BIOMEDITECH CORPORATION KTN 2016-09-23 10743816000945 Status Mono Moderate Complex card PRINCETON BIOMEDITECH CORPORATION KTN 2016-09-23 10743816000952 Status Mono Waived card PRINCETON BIOMEDITECH CORPORATION KTN 2016-09-23 10743816000969 Status Mono Waived card PRINCETON BIOMEDITECH CORPORATION KTN 2016-09-23