Home GUDID 08426950451570 ACL ELITE PRO
Primary DI 08426950451570
Brand ACL ELITE PRO
Company INSTRUMENTATION LABORATORY COMPANY
Model 00001000311
Catalog number 00001000311
Device description ACL ELITE PRO
Published 2016-09-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name JPA SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JPA System, Multipurpose For In Vitro Coagulation Studies Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08426950451570 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08426950451570 08426950451570 8426950451570
GMDN Terms# Term, Definition table Term Definition Coagulation analyser IVD, laboratory, automated A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as prothrombin time (PT), partial thromboplastin time (PTT)]. Analyser design may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry and/or mechanical means of clot formation or end point detection. The device operates with minimal technician involvement and complete automation of all procedural steps.
Regulatory Flags# DUNS number 557223252 Device count 1 Serial number true Manufacturing 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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