Home GUDID 10859035006191 Wampole ColorCard® Mono
Primary DI 10859035006191
Brand Wampole ColorCard® Mono
Company ALERE NORTH AMERICA, LLC
Model 27135
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 10859035006191 Primary GS1 0 00859035006194 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10859035006191 10859035006191 00859035006194 00859035006194 859035006194 0859035006194
GMDN Terms# Term, Definition table Term Definition Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of heterophile antibodies produced in response to Epstein-Barr virus (EBV) in a clinical specimen, using an agglutination method. The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 826027364 Device count 50 Premarket exempt true Kit true Lot or batch true Expiration date on label true Contains natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10673486014068 Teco Diagnostics Infectious Mononucleosis (IM) Latex Test TECO DIAGNOSTICS KTN 2026-05-21 20885380183635 CARDINAL HEALTH Cardinal Health 200, LLC KTN 2022-08-29 10885380183638 CARDINAL HEALTH Cardinal Health 200, LLC KTN 2022-08-29 00006136471196 Sure-Vue FISHER SCIENTIFIC COMPANY L.L.C. KTN 2017-10-27 00006136471202 Sure-Vue FISHER SCIENTIFIC COMPANY L.L.C. KTN 2017-10-27 00006136471301 Sure-Vue FISHER SCIENTIFIC COMPANY L.L.C. KTN 2017-10-27 00006136471318 Sure-Vue FISHER SCIENTIFIC COMPANY L.L.C. KTN 2017-10-27 00006136471325 Sure-Vue FISHER SCIENTIFIC COMPANY L.L.C. KTN 2017-10-27 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 10304040024130 Henry Schein HENRY SCHEIN, INC. KTN 2016-09-24 10763924516299 ACCUTEST Rapid Mono Test JANT PHARMACAL CORPORATION KTN 2016-09-24 00613647000281 Sure-Vue FISHER SCIENTIFIC COMPANY L.L.C. KTN 2016-09-24 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
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