Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3037000637

FEI Number

3037000637

Entity Name

INSTRUMENTATION LABORATORY CO. - Devens

City/State/Country

Devens, MA, US

Establishment Address

11 Grant Road, Devens, MA 01434, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Instrumentation Laboratory Co. (Owner Number: 1217183)

Owner / Operator Contact Address

180 Hartwell Road, --, Bedford, MA 01730, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K983178

PMA Number

N/A

All Registered Proprietary Names

Coatest Heparin HemosIL Normal Control 1 HemosIL Normal Control ASSAYED HemosIL Chromogenic Factor IX HemosIL Direct Thrombin Inhibitor Assay (0020302800) HemosIL Liquid Anti-Xa (Part No. 0020302601) ROTEM sigma ROTROL N ROTEM sigma complete + hep ROTEM sigma ROTROL P ROTEM sigma Thromboelastometry System HemosIL Plasminogen HemosIL Heparin ACL TOP 750 LAS ACL TOP 550 CTS ACL TOP 750 CTS ACL TOP 750 ACL TOP 350 CTS HemosIL HIT-Ab(PF4-H) Controls HemosIL HIT-Ab(PF4-H) GEM Premier 7000 with iQM3 PAK GEM Premier 7000 with iQM3 ACL TOP 970 CL Coatest APC Resistance Control Plasma Level 1 Coatest APC Resistance Coatest APC Resistance Control Plasma Level 2 HemosIL CL Anti-B2 Glycoprotein-I IgM ACL TOP 970 CL HemosIL CL Anti-Cardiolipin IgM HemosIL Factor V Deficient Plasma HemosIL Factor XII Deficient Plasma HemosIL Plasmin Inhibitor Coamatic Protein Free-S Coaset Factor VII HemosIL Calibration Plasma HemosIL Fibrinogen-C HemosIL Fibrinogen-C XL HemosIL D-Dimer HS 500 Controls ISIweb HemosIL INR Validate HemosIL ISI Calibrate ACL TOP 300 CTS ACL TOP CTS (Refurb) ACL TOP 500 CTS ACL TOP 700 (Refurb) ACL TOP 700 CTS ACL TOP 700 ACL TOP 700 LAS ACL TOP 700 CTS (Refurb) ACL TOP 500 CTS (Refurb) ACL TOP 300 CTS (Refurb) HemosIL AcuStar Anti-B2 Glycoprotein-I IgG Controls HemosIL AcuStar Anti-B2 Glycoprotein-I IgG HemosIL AcuStar Anti-B2 Glycoprotein-I IgM HemosIL AcuStar Anti-B2 Glycoprotein-I IgM Controls ACL TOP 750 CTS ACL TOP 550 CTS ACL TOP 750 LAS ACL TOP 750 ACL TOP 350 CTS ELECTRACHROME Factor VIII Coamatic Factor VIII HemosIL Apixaban Calibrators HemosIL Liquid Anti-Xa COATEST SP FVIII COATEST SP4 FVIII HemosIL Protein S Activity HemosIL Plasma Coagulation Control Level 1 HemosIL Plasma Coagulation Control Level 2 HemosIL Rivaroxaban Controls HemosIL Apixaban Controls HemosIL Dabigatran Controls IL PVP Multi-4 CO-Oximeter Control, Multi Avox-4 Co-Oximeter Control - L2 Multi-4 CO-Oximeter Control - Level 2 Avox-4 Co-Oximeter Control - L3 GEM ChemSTAT CVP 2 GEM ChemSTAT CVP 3 GEM ChemSTAT CVP 4 GEM ChemSTAT PVP 1-5 ChemSTAT System Evaluator 1 Avox-4 Co-Oximeter Control Multi-4 CO-Oximeter Control - Level 3 Avox-4 Co-Oximeter Control - L1 Multi-4 CO-Oximeter Control - Level 1 GEM ChemSTAT CVP 1 ChemSTAT System Evaluator 2 ChemSTAT System Evaluator 3 GEM CVP 5 tBili GEM System Evaluator 3 GEM System Evaluator 1 GEM System Evaluator 2 HemosIL Free Protein S HemosIL Liquid AT Substrate HemosIL Liquid Antithrombin HemosIL Routine Control Level 1 HemosIL Routine Control Level 3 HemosIL Routine Control Level 2 GEM HEMATOCRIT EVALUATOR 1, 2, 3 GEM SYSTEM EVALUATOR 1, 2, 3 GEM CVP 5 tBILI HemosIL Q.F.A. Thrombin (Bovine) HemosIL D-Dimer HS 500 Controls HemosIL Special Test Control Level 2 HemosIL Special Test Control Level 1 HemosIL Dabigatran Calibrators HemosIL Rivaroxaban Calibrators HemosIL Apixaban Calibrators GEM CVP 4 GEM CVP 1 GEM CVP Multipak GEM CVP 3 GEM Premier 3000 PAK GEM Premier 3500/3000 PAK GEM CVP 2 ACL TOP 770 LAS ACL TOP 570 ACL TOP 770 ACL TOP 770s ACL TOP 970 CL GEM Premier 5000 PAK Calibration Plasma LMW Heparin HemosIL von Willebrand Factor Antigen GEM Crit Check ContrIL 7 1, 2, 3 and Multipak HemosIL PT-Fibrinogen HS PLUS HemosIL Factor V Leiden HemosIL Factor V Reagent Plasma Coatest APC Resistance V S Coatest APC Resistance V GEM Premier 5000 PAK HemosIL Dabigatran Controls HemosIL Rivaroxaban Controls HemosIL Apixaban Controls HemosIL Abnormal Control 3 HemosIL High Abnormal Control ASSAYED GEM Premier 5000 (Instrument) GEM Premier 5000 PAK HemosIL Factor IX Deficient Plasma HemosIL AcuStar D-Dimer HemosIL AcuStar D-Dimer Controls AcuStar BIO-FLASH HemosIL von Willebrand Factor Activity HemosIL Factor VIII Deficient Plasma HemosIL Abnormal Control 2 HemosIL Low Abnormal Control ASSAYED HemosIL Fibrinogen-C HemosIL Fibrinogen-C XL HemosIL LA Positive Control HemosIL LA Negative Control NATEM Assay ROTROL N ROTEM Delta Instrument hep-TEM Assay star-TEM ROTROL P in-TEM Assay HemosIL Factor VIII Deficient Plasma HemosIL D-Dimer HemosIL dRVVT Screen HemosIL dRVVT Confirm HemosIL Apixaban Controls HemosIL Dabigatran Calibrators HemosIL Apixaban Calibrators HemosIL Rivaroxaban Calibrators HemosIL Factor X Deficient Plasma HemosIL Low Fibrinogen Control HemosIL CL HIT-IgG(PF4-H) EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMET HemosIL D-Dimer HS 500 ContrIL 9 Level 2 ContrIL 9 Multipak ContrIL 9 Level 3 ContrIL 9 Level 1 GEM Premier 5000 PAK Coamatic Heparin

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2012-12-17
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2007-11-30
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2024-04-11
QBG	Assay, Oral Direct Thrombin Inhibitor	Unknown	Class N	N/A	2018-03-13
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2025-02-28
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2012-11-02
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2012-11-02
GKP	Instrument, Coagulation, Automated	Hematology	Class 2	864.5400	2016-09-20
LCO	Platelet Factor 4 Radioimmunoassay	Hematology	Class 2	864.7695	2016-07-14
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2023-08-23
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2023-08-23
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2023-08-23
GHS	Assay, Carboxyhemoglobin	Hematology	Class 2	864.7425	2023-08-23
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2023-08-23
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	2023-08-23
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2023-08-23
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2023-08-23
GLY	Oximeter To Measure Hemoglobin	Hematology	Class 2	864.7500	2023-08-23
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2023-08-23
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2023-08-23
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2023-08-23
GKP	Instrument, Coagulation, Automated	Hematology	Class 2	864.5400	2024-04-11
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2024-04-11
GGW	Test, Time, Partial Thromboplastin	Hematology	Class 2	864.7925	2012-12-18
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2024-04-11
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2024-04-11
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2024-04-11
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2012-12-11
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2018-05-10
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2012-11-02
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2012-12-12
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-11-30
KQJ	System, Fibrinogen Determination	Hematology	Class 2	864.7340	2025-12-16
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2012-12-26
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2012-12-26
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2012-12-26
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2012-12-26
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2012-12-26
GKP	Instrument, Coagulation, Automated	Hematology	Class 2	864.5400	2016-06-22
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2011-09-21
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2011-09-21
GKP	Instrument, Coagulation, Automated	Hematology	Class 2	864.5400	2024-09-12
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2012-12-11
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2021-03-12
QLU	Anti-Factor Xa Activity Test System, Apixaban	Hematology	Class 2	864.7295	2020-10-07
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2012-12-17
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2012-12-11
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2012-12-12
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2018-03-08
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2012-12-26
JBQ	Antithrombin Iii Quantitation	Hematology	Class 2	864.7060	2012-11-02
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2012-11-02
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2017-02-14
GLK	Control, Hematocrit	Hematology	Class 2	864.8625	2017-02-14
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2017-02-14
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2017-02-14
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2017-02-14
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2017-02-14
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2017-02-14
GJA	Test, Thrombin Time	Hematology	Class 2	864.7875	2007-11-30
GIS	Test, Fibrinogen	Hematology	Class 2	864.7340	2007-11-30
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2015-06-29
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2007-11-30
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2014-09-23
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2012-12-26
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-12-26
GKP	Instrument, Coagulation, Automated	Hematology	Class 2	864.5400	2023-09-26
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2020-05-15
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2017-02-14
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2017-02-14
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2017-02-14
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2007-12-03
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2007-12-03
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2020-08-21
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2008-06-03
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2008-06-03
JFO	Fluorometric, Calcium	Clinical Chemistry	Class 2	862.1145	2008-06-03
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2008-06-03
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	2008-06-03
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2012-11-02
GIS	Test, Fibrinogen	Hematology	Class 2	864.7340	2012-11-02
GGW	Test, Time, Partial Thromboplastin	Hematology	Class 2	864.7925	2007-11-30
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	2017-02-14
GLY	Oximeter To Measure Hemoglobin	Hematology	Class 2	864.7500	2017-02-14
GHS	Assay, Carboxyhemoglobin	Hematology	Class 2	864.7425	2017-02-14
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2017-02-14
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2014-09-23
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2012-12-11
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2021-08-30
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2021-08-30
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2021-08-30
GLY	Oximeter To Measure Hemoglobin	Hematology	Class 2	864.7500	2021-08-30
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2021-08-30
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2021-08-30
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2021-08-30
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2021-08-30
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	2021-08-30
GHS	Assay, Carboxyhemoglobin	Hematology	Class 2	864.7425	2021-08-30
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2021-08-30
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2021-08-30
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2012-12-11
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2012-12-11
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2011-12-12
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2011-12-12
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2011-12-12
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2012-12-26
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2012-12-11
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2012-12-11
KQJ	System, Fibrinogen Determination	Hematology	Class 2	864.7340	2012-11-02
GIZ	Plasma, Control, Normal	Hematology	Class 2	864.5425	2018-03-09
GGC	Control, Plasma, Abnormal	Hematology	Class 2	864.5425	2018-03-09
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2018-03-09
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2025-02-28
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2025-02-28
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2012-12-11
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2012-12-26
GGC	Control, Plasma, Abnormal	Hematology	Class 2	864.5425	2011-09-20
GIR	Reagent, Russel Viper Venom	Hematology	Class 1	864.8950	2011-09-20
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2021-03-12
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2021-07-23
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2012-12-11
KQJ	System, Fibrinogen Determination	Hematology	Class 2	864.7340	2007-11-07
LCO	Platelet Factor 4 Radioimmunoassay	Hematology	Class 2	864.7695	2025-09-12
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2025-02-28
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2018-03-09
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-12-26
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2012-12-26
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2017-02-14
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2007-10-12

Official Correspondent

Carol Marble

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Instrumentation Laboratory Co.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1217183	INSTRUMENTATION LABORATORY CO.	Bedford, MA, US
2431530	INSTRUMENTATION LABORATORY CO.	ORANGEBURG, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K980242	Instrumentation Laboratory CO	IL TEST HEPARIN	1998-03-19
K021022	Instrumentation Laboratory CO	HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)	2002-05-14
K113211	Instrumentation Laboratory CO	HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL	2012-01-04
K082859	Instrumentation Laboratory CO	HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED	2008-12-19
K972288	Universal Reagents, Inc.	FACTOR DEFICIENT PLASMAS - FACTOR IX (9)	1997-07-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-04	Instrumentation Laboratory Co.	1	Lactate Disposable Membrane Caps Product Number: 0018108400
Z-0077-2019	Instrumentation Laboratory Co.	2	Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.
Z-0135-2011	Instrumentation Laboratory Co.	2	ACL TOP (Base) PN 000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Z-0136-2011	Instrumentation Laboratory Co.	2	ACL TOP 500 CTS PN 000280040 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
Z-0137-2011	Instrumentation Laboratory Co.	2	ACL TOP 700 LAS PN 000280030 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3037000637. Last updated year: 2026. Please use registration number 3037000637 when referencing this establishment in official correspondence.