classification Plasma, Coagulation Control Manufacturer:

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gudid The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use as a serum QC control to monitor and evaluate precision and accuracy of the (qualitative) PIFA Heparin/PF4 Rapid Assay. Included are both confirmed positive and negative control panel members. Manufacturer: AKERS BIOSCIENCES, INC.

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gudid The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use as a serum QC control to monitor and evaluate precision and accuracy of the (qualitative) PIFA Heparin/PF4 Rapid Assay. Included are both confirmed positive and negative control panel members. Manufacturer: AKERS BIOSCIENCES, INC.

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gudid i-STAT ACT, CONTROL LEVEL 2 Manufacturer: ABBOTT POINT OF CARE INC.

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gudid i-STAT ACT, CONTROL LEVEL 1 Manufacturer: ABBOTT POINT OF CARE INC.

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gudid i-STAT PT, CONTROL LEVEL 2 Manufacturer: ABBOTT POINT OF CARE INC.

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gudid i-STAT PT, CONTROL LEVEL 1 Manufacturer: ABBOTT POINT OF CARE INC.

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gudid 1. Rivaroxaban Low Control (Cat. No. 0020015510): 5 x 1mL vials 2. Rivaroxaban High Control (Cat. No. 0020015520): 5 x 1mL vials Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid 1. Low HIT Control (Cat. No. 00009800132)2. High HIT Control (Cat. No. 00009800133): Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL D-Dimer HS 500 Controls (Liquid) Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL CL Multi-Ab Controls kit 1) Low Multi-Ab Control (Cat. No. 0029704010): 3 x 2 mL2) High Multi-Ab Control (Cat. No. 0029704020): 3 x 2 mL Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL HIT-Ab(PF4-H) Controls Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL Abnormal Control 3 Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL Abnormal Control 2 Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL Normal Control 1 Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL D-Dimer HS 500 Controls (Liquid) Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL LA Positive Control Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL LA Negative Control Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL AcuStar D-Dimer Controls Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL INR Validate Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL Factor V Deficient Plasma (10 X 1 mL) Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL D-Dimer HS 500 Controls Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid GEM Check Coag Control-Normal for ACT-LR Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid GEM Check Coag Control-Normal for ACT Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid GEM Check Coag Control-Normal for PT Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid GEM Check Coag Control-Abnormal for Citrate PT Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid GEM Check Coag Control-Abnormal for PT Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid GEM Check Coag Control-Normal for APTT Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid GEM Check Coag Control-Normal for Citrate PT Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid GEM Check Coag Control-Abnormal for ACT Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid GEM Check Coag Control-Abnormal for ACT-LR Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid GEM Check Coag Control-Abnormal for APTT Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid Control Plasma LMW Heparin Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL High Abnormal Control ASSAYED Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL Low Abnormal Control ASSAYED Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL Normal Control ASSAYED Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL D-Dimer Controls Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid For quality control of the INNOVANCE Heparin assay Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid For quality control of the INNOVANCE Heparin assay Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid For quality control of the INNOVANCE Heparin assay Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid For quality control of the INNOVANCE Heparin assay Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid Assayed control used to monitor the performance of coagulation assays in the normal range Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid Assayed control to monitor the performance of Factor V Leiden assay in the pathological range Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid For use as control in citrated coagulation systems Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid For use as control in citrated coagulation systems Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid 1. Level 1 D-D Control(Cat. No. 0022660031): 5 vials x 1 mL2. Level 2 D-D Control(Cat. No. 0022660032): 5 vials x 1 mL Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid HemosIL Apixaban Controls kit consists of:1. Apixaban Low Control (Cat. No. 0020015310): 5 x 1 mL vials 2. Apixaban High Control (Cat. No. 0020015320): 5 x 1 mL vials Manufacturer: INSTRUMENTATION LABORATORY COMPANY

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gudid Control plasma for assays aimed to determine the functional phenotype for activated protein C resistance caused by the Factor V Leiden mutation (FV:Q506). Manufacturer: Pentapharm AG

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gudid The ROTEM delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively. Manufacturer: Tem Innovations GmbH

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gudid ROTROL P is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM delta Thromboelastometry System. For in vitro diagnostic use only. Manufacturer: Tem Innovations GmbH

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gudid The ROTEM delta is designed for in-vitro diagnostic use by professionals in a laboratory environ-ment. The ROTEM delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve clot firmness over time) and several defined numerical parameters describing the curve quantitatively.The star-tem reagent is intended for use as recalcification reagent in the NATEM and INTEM assay on the ROTEM delta. The corresponding assays are described in the NATEM assay application sheet and in the Instructions for Use of the in-tem reagent (REF 503-02-US), resp. Manufacturer: Tem Innovations GmbH

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gudid The ROTEM delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.The in-tem assay is a semi-quantitative in vitro diagnostic assay used to monitor the coagulation process via the intrinsic pathway in citrated whole blood specimens on the ROTEM delta. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). Manufacturer: Tem Innovations GmbH

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gudid CoaguChek XS Pro PT controls Manufacturer: Roche Diagnostics GmbH

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gudid Thermo Scientific Pacific Hemostasis Manufacturer: Fisher Diagnostics

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gudid Thermo Scientific Pacific Hemostasis Manufacturer: Fisher Diagnostics

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gudid Thermo Scientific Pacific Hemostasis Manufacturer: Fisher Diagnostics

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gudid Thermo Scientific Pacific Hemostasis Manufacturer: Fisher Diagnostics

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gudid Thermo Scientific Pacific Hemostasis Manufacturer: Fisher Diagnostics

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gudid Thermo Scientific Pacific Hemostasis Manufacturer: Fisher Diagnostics

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gudid Thermo Scientific Pacific Hemostasis Manufacturer: Fisher Diagnostics

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gudid Thermo Scientific Pacific Hemostasis Manufacturer: Fisher Diagnostics

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gudid STA - Quality HBPM/LMWH Manufacturer: DIAGNOSTICA STAGO

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gudid STA - System Control N + P Manufacturer: DIAGNOSTICA STAGO

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gudid STA - Coag Control (N + ABN) PLUS Manufacturer: DIAGNOSTICA STAGO

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gudid STA - Liatest Control N + P Manufacturer: DIAGNOSTICA STAGO

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gudid STA - Quality HNF/UFH Manufacturer: DIAGNOSTICA STAGO

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gudid CueSee Coag is an unassayed quality control material intended to verify the precision of prothrombin time (PT), International Normalized Ratio (INR), activated clotting time (ACT) and/or activated partial thromboplastin time (aPTT) measurements on coagulation analyzers in the clinically relevant range. For laboratory and near-patient (point-of-care) testing by healthcare professionals. Manufacturer: Eurotrol B.V.

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gudid CueSee Coag is an unassayed quality control material intended to verify the precision of prothrombin time (PT), International Normalized Ratio (INR), activated clotting time (ACT) and/or activated partial thromboplastin time (aPTT) measurements on coagulation analyzers in the clinically relevant range. For laboratory and near-patient (point-of-care) testing by healthcare professionals. Manufacturer: Eurotrol B.V.

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gudid CueSee Coag is an unassayed quality control material intended to verify the precision of prothrombin time (PT), International Normalized Ratio (INR), activated clotting time (ACT) and/or activated partial thromboplastin time (aPTT) measurements on coagulation analyzers in the clinically relevant range. For laboratory and near-patient (point-of-care) testing by healthcare professionals. Manufacturer: Eurotrol B.V.

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gudid CueSee Coag is an unassayed quality control material intended to verify the precision of prothrombin time (PT), International Normalized Ratio (INR), activated clotting time (ACT) and/or activated partial thromboplastin time (aPTT) measurements on coagulation analyzers in the clinically relevant range. For laboratory and near-patient (point-of-care) testing by healthcare professionals. Manufacturer: Eurotrol B.V.

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gudid CueSee Coag is an unassayed quality control material intended to verify the precision of prothrombin time (PT), International Normalized Ratio (INR), activated clotting time (ACT) and/or activated partial thromboplastin time (aPTT) measurements on coagulation analyzers in the clinically relevant range. For laboratory and near-patient (point-of-care) testing by healthcare professionals. Manufacturer: Eurotrol B.V.

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gudid Assayed control used to monitor the performance of coagulation assays in the normal range Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid Assayed control to monitor the performance of Factor V Leiden assay in the pathological range Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid For use as control in citrated coagulation systems Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid For use as control in citrated coagulation systems Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid For quality control of the INNOVANCE Heparin assay Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid For quality control of the INNOVANCE Heparin assay Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid For quality control of the INNOVANCE Heparin assay Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid For quality control of the INNOVANCE Heparin assay Manufacturer: Siemens Healthcare Diagnostics Products GmbH

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gudid The Xprecia System PT Controls; For use with Xprecia System, supplying assayed controls for prothrombin time (PT). Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid The Xprecia Stride Coagulation System is intended for use by professional healthcare providers to provide an INR (InternationalNormalized Ratio) based on a Prothrobin time (PT) response for the monitoring of oral anticoagulation therapy with Warfarin. Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid Coagulation S.A.R.P (Specialty Assayed Reference Plasma) Manufacturer: HELENA LABORATORIES CORPORATION

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gudid AB-Trol 3 Coagulation Control Manufacturer: HELENA LABORATORIES CORPORATION

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gudid A pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.05M HEPES and stabilizers, dispensed and lyophilized. This plasma is used for the quality control of coagulation assays in the normal range, including fibrinogen, coagulation factors II, V, VII, VIII, IX, X XI and XII, ATIII activity, Protein C activity and Protein S activity. Manufacturer: Affinity Biologicals Inc

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gudid A pool of citrated normal human plasma collected from a minimum of 20 donors, and diluted to defined concentrations. Plasma is buffered with 0.05M HEPES and stabilizers, dispensed and lyophilized. This plasma is used for the quality control of coagulation assays in the normal range, including fibrinogen, coagulation factors II, V, VII, VIII, IX, X XI and XII, ATIII activity, Protein C activity and Protein S activity. Manufacturer: Affinity Biologicals Inc

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gudid A pool of citrated human plasma collected from a minimum of 20 donors that has been depleted of specific clotting factors. The plasma is buffered with 0.05M HEPES buffer and stabilizers, dispensed and lyophilized. This plasma is used for the quality control of coagulation assays (PT and APTT) in the highly abnormal range. Manufacturer: Affinity Biologicals Inc

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gudid A pool of citrated human plasma collected from a minimum of 20 donors that has been depleted of specific clotting factors. The plasma is buffered with 0.05M HEPES buffer and stabilizers, dispensed, and lyophilized. This plasma is used for the quality control of coagulation assays (PT and APTT) in the mid-level abnormal range. Manufacturer: Affinity Biologicals Inc

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gudid A pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.05M HEPES buffer and stabilizers, dispensed and lyophilized. This plasma is used for the quality control of coagulation assays (PT, APTT and Fibinogen) in the normal range. Manufacturer: Affinity Biologicals Inc

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gudid Intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) in the mid-level abnormal range. Manufacturer: Affinity Biologicals Inc

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gudid Intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT), in the mid-level abnormal range. Manufacturer: Affinity Biologicals Inc

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gudid Intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT), in the mid-level abnormal range. Manufacturer: Affinity Biologicals Inc

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gudid Intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen, in the normal range. Manufacturer: Affinity Biologicals Inc

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gudid Intended for the use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen, in the normal range. Manufacturer: Affinity Biologicals Inc

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gudid Intended for the use in quality control of quantitative coagulation assays, including Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen, in the normal range. Manufacturer: Affinity Biologicals Inc

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gudid Intended for use in the quality control of coagulation assays in the borderline pathological range. Manufacturer: Affinity Biologicals Inc

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gudid Intended for use in the quality control of coagulation assays in the borderline pathological range. Manufacturer: Affinity Biologicals Inc

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gudid Intended for use in the quality control of coagulation assays in the normal range. Manufacturer: Affinity Biologicals Inc

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gudid Intended for use in the quality control of coagulation assays in the normal range. Manufacturer: Affinity Biologicals Inc

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gudid Assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. Manufacturer: Affinity Biologicals Inc

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gudid Assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. Manufacturer: Affinity Biologicals Inc

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FDA Product Code: GGN