Home GUDID M220P0800163 Pro Advantage
Primary DI M220P0800163
Brand Pro Advantage
Company NATIONAL DISTRIBUTION & CONTRACTING, INC.
Model P080016
Catalog number P080016
Device description Pro Advantage Infectious Mono 20TST/KT
Published 2017-02-13
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
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 M220P0800165 Package HIBCC 10 M220P0800163 Primary HIBCC 0
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.
Regulatory Flags# DUNS number 009831413 Device count 1 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10885380183638 CARDINAL HEALTH Cardinal Health 200, LLC KTN 2022-08-29 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
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