Home GUDID 08426950088196 Coatest Heparin
Primary DI 08426950088196
Brand Coatest Heparin
Company INSTRUMENTATION LABORATORY COMPANY
Model 25 5539 63
Catalog number 25 5539 63
Device description Coatest Heparin
Published 2016-09-23
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 KFF ASSAY, HEPARIN
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KFF Assay, Heparin Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08426950088196 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08426950088196 08426950088196 8426950088196
GMDN Terms# Term, Definition table Term Definition Heparin anti-Xa IVD, kit, chromogenic A collection of reagents and other associated materials intended to be used for the quantitative detection of heparin by measuring its ability to inhibit the activity of activated factor X (factor Xa) in a clinical specimen, using a chromogenic method. The assay is typically used to monitor anticoagulation therapy.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 When kept at 2-8°C the sealed reagents are stable until expiry date printed on the label. Avoid contamination by microorganisms in opened vials. Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 557223252 Device count 1 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
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00630414640259 Dade Ci-Trol Heparin Control, Low Siemens Healthcare Diagnostics Products GmbH KFF 2024-03-25 00630414640365 Dade Ci-Trol Heparin Control, High Siemens Healthcare Diagnostics Products GmbH KFF 2024-03-25 00630414639864 INNOVANCE Heparin Siemens Healthcare Diagnostics Products GmbH KFF 2024-03-25 00842768019548 Dade Ci-Trol Heparin Control, Low Siemens Healthcare Diagnostics Products GmbH KFF 2024-03-25 00842768019531 Dade Ci-Trol Heparin Control, High Siemens Healthcare Diagnostics Products GmbH KFF 2024-03-25 00842768017438 INNOVANCE Heparin Siemens Healthcare Diagnostics Products GmbH KFF 2017-09-11 03663537008191 BIOPHEN HEPARIN 6 HYPHEN BIOMED KFF 2017-03-08 00842768003899 Dade® Ci-Trol® Heparin Control, Low Siemens Healthcare Diagnostics Products GmbH KFF 2016-09-24 00842768003905 Dade® Ci-Trol® Heparin Control, High Siemens Healthcare Diagnostics Products GmbH KFF 2016-09-24 00842768012945 Berichrom® Heparin Siemens Healthcare Diagnostics Products GmbH KFF 2016-09-24 08426950042211 HemosIL Heparin INSTRUMENTATION LABORATORY COMPANY KFF 2016-09-23 08426950580324 HemosIL Liquid Anti-Xa INSTRUMENTATION LABORATORY COMPANY KFF 2016-09-23 08426950088967 Coamatic Heparin INSTRUMENTATION LABORATORY COMPANY KFF 2016-09-23 08426950472476 HemosIL Liquid Heparin INSTRUMENTATION LABORATORY COMPANY KFF 2016-09-23 08426950472490 HemosIL LMW Heparin Controls INSTRUMENTATION LABORATORY COMPANY KFF 2016-09-23 10711234102176 Hemochron Whole Blood Coagulation System ACCRIVA DIAGNOSTICS HOLDINGS, INC. KFF 2016-09-22 10711234202036 Hemochron Whole Blood Coagulation System ACCRIVA DIAGNOSTICS HOLDINGS, INC. KFF 2016-09-22 10711234202081 Hemochron Whole Blood Coagulation System ACCRIVA DIAGNOSTICS HOLDINGS, INC. KFF 2016-09-22 10711234202098 Hemochron Whole Blood Coagulation System ACCRIVA DIAGNOSTICS HOLDINGS, INC. KFF 2016-09-22 10711234202104 Hemochron Whole Blood Coagulation System ACCRIVA DIAGNOSTICS HOLDINGS, INC. KFF 2016-09-22 10711234202111 Hemochron Whole Blood Coagulation System ACCRIVA DIAGNOSTICS HOLDINGS, INC. KFF 2016-09-22 00850201006031 ACTICHROME Heparin (Anti-FIIa) Biomedica ADI Inc. KFF 2016-09-20 00850201006079 ACTICHROME HEPARIN (ANTI-FXA) Biomedica ADI Inc. KFF 2016-09-20 03607450006827 STA® - HBPM/LMWH Control DIAGNOSTICA STAGO KFF 2016-09-15 03607450006841 STA® - Hepanorm® H DIAGNOSTICA STAGO KFF 2016-09-15 03607450006810 STA® - Hepanorm® HBPM/LMWH DIAGNOSTICA STAGO KFF 2016-09-15 03607450011791 STA® - Liquid Anti-Xa 8 DIAGNOSTICA STAGO KFF 2016-09-15 03607450009064 Stachrom® Heparin DIAGNOSTICA STAGO KFF 2016-09-15 03607450006834 STA® - Heparin Control DIAGNOSTICA STAGO KFF 2016-09-15 03607450011784 STA® - Liquid Anti-Xa 4 DIAGNOSTICA STAGO KFF 2016-09-15