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Coagulation analyser IVD, laboratory

Definition
An electrically-powered automated or semi-automated 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, electromagnetic and/or mechanical means of clot formation or end point detection.
GUDID devices
44
Last updated
2026-06-12 06:05:18

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850003761107Quantra QPlus SystemHEMOSONICS, LLCKT-00392021-02-11
08430793045476ACL TOP 970 CLINSTRUMENTATION LABORATORY COMPANY000002800972025-10-02
10850003761180QStat CartridgeHEMOSONICS, LLCQStat Cartridge KIT (Box of 10)2024-02-29
M525XLECT10Helena Electronic Clotting TubeHELENA LABORATORIES CORPORATIONXL-ECT12017-03-17
04987562499700Automated Blood Coagulation Analyzer CN-3000SYSMEX CORPORATIONCL9710292025-12-19
04987562518616Automated Blood Coagulation Analyzer CN-3000SYSMEX CORPORATIONBN3433152025-12-19
04987562518654Automated Blood Coagulation Analyzer CS-5100SYSMEX CORPORATIONCU6241382024-02-22
04987562518661Automated Blood Coagulation Analyzer CS-2500SYSMEX CORPORATIONAG5283552024-02-22
04987562518678Automated Blood Coagulation Analyzer CA-600 series CA-620SYSMEX CORPORATIONCM2172732024-02-22
04987562518685Automated Blood Coagulation Analyzer CA-600 series CA-660SYSMEX CORPORATIONCA1748982024-02-22
04987562499687Automated Blood Coagulation Analyzer CN-6000SYSMEX CORPORATIONCV3397632025-08-22
04987562518630Automated Blood Coagulation Analyzer CN-6000SYSMEX CORPORATIONAX8016452025-08-22
00195226000528ACL TOP 770INSTRUMENTATION LABORATORY COMPANY000002800572024-05-15
00195226000535ACL TOP 770 LASINSTRUMENTATION LABORATORY COMPANY000002800372024-05-15
00195226000542ACL TOP 770sINSTRUMENTATION LABORATORY COMPANY000002800172024-05-15
00195226000559ACL TOP 570INSTRUMENTATION LABORATORY COMPANY000002800472024-05-15
00195226000566ACL TOP 370INSTRUMENTATION LABORATORY COMPANY000002800672024-05-15
00850003761336Qstat Control Level 1HEMOSONICS, LLCQStat Control Level 1 Kit (Box of 4)2024-02-29
00850003761398Qstat Control Level 2HEMOSONICS, LLCQStat Control Level 2 Kit (Box of 4)2024-02-29
00850003761183QStat CartridgeHEMOSONICS, LLCQStat Cartridge KIT (Box of 10)2024-02-29
M52517110000Cascade M-4 (110V/220V)HELENA LABORATORIES CORPORATION17110002016-08-22
M52557530000"Actalyke Mini II, w/ Printer, w/o Battery, ""CE"" (110V/220V)"HELENA LABORATORIES CORPORATION57530002016-08-22
M52557530010"Actalyke Mini II, w/ Printer, w/o Battery, ""CE 2009"" (110V/220V)"HELENA LABORATORIES CORPORATION57530012016-08-22
M52557550000"Actalyke Mini II, w/o Printer & Battery., ""CE"" (110V/220V)"HELENA LABORATORIES CORPORATION57550002016-08-22
M52557550010"Actalyke Mini II, w/o Printer & Battery, ""CE 2009"" (110V/220V)"HELENA LABORATORIES CORPORATION57550012016-08-22
M52557570000Actalyke ThermometerHELENA LABORATORIES CORPORATION57570002017-03-17
M52557700010"Actalyke XL, Dual Detection, (New Display) ""CE"" (110V/220V)"HELENA LABORATORIES CORPORATION57700012016-08-22
M52557700020"Actalyke XL, Dual Detection, (Display #2) ""CE"" (110V/220V)"HELENA LABORATORIES CORPORATION57700022016-08-22
M52557700030Actalyke XL, (CSA/CE), New Display #2 (110V/220V)HELENA LABORATORIES CORPORATION57700032016-08-22
M52557700040Actalyke XL, (CSA/CE), W/ Flash MemoryHELENA LABORATORIES CORPORATION57700042016-08-22
10711234515044GEM Hemochron 100 SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.000GH100L2022-10-06
04260160470372ROTEM®Tem Innovations GmbHsigma2022-10-04
03607450581041STA Satellite®DIAGNOSTICA STAGO581042016-09-15
03607450589788STA-R Evolution® Expert SeriesDIAGNOSTICA STAGO589782016-09-15
03607450589795STA-R Evolution® Expert Series (with cap piercing option)DIAGNOSTICA STAGO589792016-09-15
03607450589894STA Compact Max® (with cap piercing option)DIAGNOSTICA STAGO589892016-09-15
03607450589900STA Compact Max®DIAGNOSTICA STAGO589902016-09-15
03607450590104STA R Max® (with cap piercing option)DIAGNOSTICA STAGO590102016-09-15
03607450590135STA R Max®DIAGNOSTICA STAGO590132016-09-15
03607450590265STA R Max®DIAGNOSTICA STAGO590262018-10-30
03607450590272STA R Max® (with cap piercing option)DIAGNOSTICA STAGO590272018-10-30
10812747018142TEG5000HAEMONETICS CORPORATION01-0962017-05-30
10812747018159TEG5000HAEMONETICS CORPORATION01-0972017-03-13
10812747018456TEG5000HAEMONETICS CORPORATION01-1972017-07-17