Home GUDID 00195226000023 HemosIL Apixaban Calibrators
Primary DI 00195226000023
Brand HemosIL Apixaban Calibrators
Company INSTRUMENTATION LABORATORY COMPANY
Model 0020015200
Catalog number 00020015200
Device description HemosIL Apixaban Calibrators kit consists of:1. Apixaban Calibrator 1 (0020015210): 5 x 1 mL vials2. Apixaban Calibrator 2 (0020015220): 5 x 1 mL vials
Published 2021-03-15
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name DLJ Calibrators, Drug Specific JIT Calibrator, Secondary
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DLJ Calibrators, Drug Specific Clinical Toxicology 2 JIT Calibrator, Secondary Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00195226000023 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00195226000023 00195226000023 195226000023 0195226000023
GMDN Terms# Term, Definition table Term Definition Coagulation factor Xa inhibitor IVD, calibrator A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of activated coagulation factor Xa inhibitor in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 557223252 Device count 1 Premarket exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 08426950071068 HemosIL Normal Control ASSAYED 00020003110 00020003110 2016-09-23 08426950088646 GEM Check Coag Control-Abnormal for ACT-LR 06260060200 06260060200 2016-09-23 08426950088653 GEM Check Coag Control-Abnormal for ACT 06260060300 06260060300 2016-09-23 08426950452683 GEM Check Coag Control-Normal for Citrate PT 06260061100 06260061100 2016-09-23 08426950452713 GEM Check Coag Control-Abnormal for Citrate PT 06260061400 06260061400 2016-09-23 08426950452744 GEM Check Coag Control-Normal for ACT 06260060500 06260060500 2016-09-23 08426950452751 GEM Check Coag Control-Normal for ACT-LR 06260060600 06260060600 2016-09-23 08426950573401 HemosIL Routine Control Level 3 00020005800 00020005800 2016-09-23 08426950660668 HemosIL Abnormal Control 2 00020014000 00020014000 2016-09-23 08426950078982 HemosIL Low Abnormal Control ASSAYED 00020003210 00020003210 2016-09-23 08426950078999 HemosIL High Abnormal Control ASSAYED 00020003310 00020003310 2016-09-23 08426950087595 HemosIL Calibration Plasma 00020003700 00020003700 2016-09-23 08426950088639 GEM Check Coag Control-Abnormal for APTT 06260060100 06260060100 2016-09-23 08426950088912 Coatest APCR Control Plasma Level 1 82 2650 63 82 2650 63 2016-09-23 08426950088929 Coatest APCR Control Plasma Level 2 82 2668 63 82 2668 63 2016-09-23 08426950442189 HemosIL Special Test Control Level 2 00020012000 00020012000 2016-09-23 08426950452690 GEM Check Coag Control-Normal for APTT 06260061600 06260061600 2016-09-23 08426950452706 GEM Check Coag Control-Abnormal for PT 06260061700 06260061700 2016-09-23 08426950452737 GEM Check Coag Control-Normal for PT 06260060400 06260060400 2016-09-23 08426950453062 HemosIL Special Test Control Level 1 00020011000 00020011000 2016-09-23
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