FDA.reportPublic FDA data

Coagulation analyser IVD, laboratory, automated

Definition
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.
GUDID devices
35
Last updated
2021-07-09 14:57:53

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08426950003151Rotors 100 pcs 2000 wellsINSTRUMENTATION LABORATORY COMPANY000068000002016-09-23
08426950075899Cuvettes (2400 cuvettes)INSTRUMENTATION LABORATORY COMPANY000294001002016-09-23
08426950451570ACL ELITE PROINSTRUMENTATION LABORATORY COMPANY000010003112016-09-23
08426950497059ACL AcuStar cuvettes (1400 pcs)INSTRUMENTATION LABORATORY COMPANY00098011002016-09-23
08426950498001HemosIL AcuStarINSTRUMENTATION LABORATORY COMPANY00098010002016-09-23
08426950784074ACL TOP 750INSTRUMENTATION LABORATORY COMPANY000002800152016-09-23
08426950784081ACL TOP 350 CTSINSTRUMENTATION LABORATORY COMPANY000002800652016-09-23
08426950927990ACL TOP 700INSTRUMENTATION LABORATORY COMPANY00000280010R2016-09-23
08426950451600ACL TOP CTSINSTRUMENTATION LABORATORY COMPANY00000280020R2016-09-23
08426950453017ACL ELITEINSTRUMENTATION LABORATORY COMPANY000008803112016-09-23
08426950453482ACL ELITE PROINSTRUMENTATION LABORATORY COMPANY00001000311R2016-09-23
08426950453499ACL TOP 500 CTSINSTRUMENTATION LABORATORY COMPANY000002800402016-09-23
08426950497974ACL TOP 700INSTRUMENTATION LABORATORY COMPANY000002800102016-09-23
08426950497981ACL TOP 700 CTSINSTRUMENTATION LABORATORY COMPANY000002800502016-09-23
08426950497998ACL TOP 700 LASINSTRUMENTATION LABORATORY COMPANY000002800302016-09-23
08426950556916ACL TOP 300 CTSINSTRUMENTATION LABORATORY COMPANY000002800602016-09-23
08426950729242ACL TOP 550 CTSINSTRUMENTATION LABORATORY COMPANY000002800452016-09-23
08426950784050ACL TOP 750 LASINSTRUMENTATION LABORATORY COMPANY000002800352016-09-23
08426950784067ACL TOP 750 CTSINSTRUMENTATION LABORATORY COMPANY000002800552016-09-23
08426950928003ACL TOP 500 CTSINSTRUMENTATION LABORATORY COMPANY00000280040R2016-09-23
08426950928010ACL TOP 700 CTSINSTRUMENTATION LABORATORY COMPANY00000280050R2016-09-23
08426950928027ACL TOP 300 CTSINSTRUMENTATION LABORATORY COMPANY00000280060R2018-05-28
08426950965572ACL ELITEINSTRUMENTATION LABORATORY COMPANY00000880311R2016-09-23
20812747018132TEG5000 HEMOSTASIS SYSTEMHAEMONETICS CORPORATION62112017-07-11
30812747018351TEG6s HEMOSTASIS SYSTEMHAEMONETICS CORPORATION07-690-US2017-07-31
04987562409471Automated Blood Coagulation Analyzer CS-2100iSYSMEX CORPORATION063725112016-09-29
04987562425426Automated Blood Coagulation Analyzer CS-5100SYSMEX CORPORATIONBY9907572016-08-05
04987562425686Automated Blood Coagulation Analyzer CA-600 series CA-620SYSMEX CORPORATIONBR1426262016-08-04
04987562425716Automated Blood Coagulation Analyzer CA-600 series CA-660SYSMEX CORPORATIONCK9782892016-08-05
04987562433735Automated Blood Coagulation Analyzer CS-2500SYSMEX CORPORATIONBV9817982016-09-16
05391521421029Destiny PlusTCOAG IRELAND LIMITEDH01000P2016-09-12
05391521421081Destiny MAX AnalyzerTCOAG IRELAND LIMITEDM010002016-09-12
00842768012198Behring Coagulation CupSiemens Healthcare Diagnostics Products GmbH104465262017-10-31
00842768014444BCS® System Cuvette RotorsSiemens Healthcare Diagnostics Products GmbH104465242017-10-31
00630414945514BCS® XP SystemSiemens Healthcare Diagnostics Products GmbH104593302016-09-24