Other products from "AFFINITY BIOLOGICALS INC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 10629009111103 LCSAB201 A pool of citrated human plasma collected from a minimum of 20 donors that has b 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. GGN Plasma, Coagulation Control VisuCon-L Coag Screen ABN2 Plasma
2 10629009051058 FRNCP0105 Intended for use in the quality control of coagulation assays in the normal range. GGN Plasma, Coagulation Control VisuCon-F Frozen Calibrator Plasma
3 10629009101104 LCSAB101 A pool of citrated human plasma collected from a minimum of 20 donors that has b 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. GGN Plasma, Coagulation Control VisuCon-L Coag Screen ABN1 Plasma
4 10629009020009 FIX-AG 96 Test enzyme immunoassay kit for the determination of FIX Antigen GGP Test, Qualitative And Quantitative Factor Deficiency VisuLize Factor FIX Antigen Kit
5 10629009010000 FVIII-AG 96 Test enzyme immunoassay kit for the determination of FVIII Antigen GGP Test, Qualitative And Quantitative Factor Deficiency VisuLize Factor FVIII Antigen Kit
6 10629009051256 FRNCP0125 Intended for use in the quality control of coagulation assays in the normal range. GGN Plasma, Coagulation Control VisuCon-F Frozen Normal Control Plasma
7 10629009031814 LFGCP0181 Assayed control plasma prepared from de-fibrinated human plasma intended for use 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. GGN Plasma, Coagulation Control VisuCon-F Low Fibrinogen Control Plasma
8 10629009061057 FRABP0105 Intended for use in the quality control of coagulation assays in the borderline Intended for use in the quality control of coagulation assays in the borderline pathological range. GGN Plasma, Coagulation Control VisuCon-F Frozen Abnormal Control Plasma
9 10629009031258 LFGCP0125 Assayed control plasma prepared from de-fibrinated human plasma intended for use 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. GGN Plasma, Coagulation Control VisuCon-F Low Fibrinogen Control Plasma
10 10629009031050 LFGCP0105 Assayed control plasma prepared from de-fibrinated human plasma intended for use 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. GGN Plasma, Coagulation Control VisuCon-F Low Fibrinogen Control Plasma
11 10629009081819 FCSAB0181 Intended for use in the quality control of quantitative coagulation assays, incl 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. GGN Plasma, Coagulation Control VisuCon-F Frozen Coag Screen ABN
12 10629009081253 FCSAB0125 Intended for use in the quality control of quantitative coagulation assays, incl 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. GGN Plasma, Coagulation Control VisuCon-F Frozen Coag Screen ABN
13 10629009084810 FCSAB0481 Intended for use in the quality control of quantitative coagulation assays, incl 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. GGN Plasma, Coagulation Control VisuCon-F Frozen Coag Screen ABN
14 10629009041059 FRSP0105 Intended for use in the calibration of coagulation and fibrinolysis assays. JIX Calibrator, Multi-Analyte Mixture Visu-Cal F Frozen Calibrator Plasma
15 10629009074811 FCSN0481 Intended for use in the quality control of quantitative coagulation assays, incl 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. GGN Plasma, Coagulation Control VisuCon-F Frozen Coag Screen N
16 10629009071810 FCSN0181 Intended for the use in the quality control of quantitative coagulation assays, 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. GGN Plasma, Coagulation Control VisuCon-F Frozen Coag Screen N
17 10629009071254 FCSN0125 Intended for the use in quality control of quantitative coagulation assays, incl 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. GGN Plasma, Coagulation Control VisuCon-F Frozen Coag Screen N
18 10629009131101 LYNCP01 A pool of normal citrated human plasma collected from a minimum of 20 donors, bu 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. GGN Plasma, Coagulation Control VisuCon-L(TM) Normal Control Plasma
19 10629009121102 LYABP01 A pool of citrated normal human plasma collected from a minimum of 20 donors, an 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. GGN Plasma, Coagulation Control VisuCon-L(TM) Abnormal Control Plasma
20 10629009091108 LSCN01 A pool of normal citrated human plasma collected from a minimum of 20 donors, bu 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. GGN Plasma, Coagulation Control VisuCon-L Coag Screen N Plasma
21 10629009145016 SAFXIII-IG-ASR-500 The specific use of this ASR (Analyte Specific Reagent) will depend upon the end The specific use of this ASR (Analyte Specific Reagent) will depend upon the end user's application. MVU Reagents, Specific, Analyte 1 Sheep anti-human Factor XIII Analyte Specific Reagent
22 10629009140516 SAFXIII-IG-ASR-5 The specific use of this ASR (Analyte Specific Reagent) will depend upon the end The specific use of this ASR (Analyte Specific Reagent) will depend upon the end-user's application. MVU Reagents, Specific, Analyte 1 Sheep anti-human Factor XIII Analyte Specific Reagent
23 10629009041257 FRSP0125 Intended for use in the calibration of coagulation and fibrinolysis assays. JIX Calibrator, Multi-Analyte Mixture VisuCal-F Frozen Calibrator Plasma
Other products with the same Product Code "GGN"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 04260160470587 delta System (US/CA) 201001 The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l 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. ROTEM® TEM INNOVATIONS GMBH
2 04260160470112 ROTROL P 503-25-US, 503-25 ROTROL P is a quality control material for monitoring accuracy and precision of 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. ROTEM® TEM INNOVATIONS GMBH
3 04260160470105 ROTROL N 503-24-US, 503-24 ROTROL N is a quality control material for monitoring accuracy and precision of ROTROL N 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. ROTEM® TEM INNOVATIONS GMBH
4 04260160470099 star-tem® 20 503-10-US The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l 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. ROTEM® TEM INNOVATIONS GMBH
5 04260160470082 hep-tem® 503-09-US The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l 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 hep-tem® assay is a semi-quantitative in vitro diagnostic assay used to inactivate heparin in patients receiving unfractionated heparin on the ROTEM® delta. To monitor the coagulation process citrated whole blood specimens are used. 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)). ROTEM® TEM INNOVATIONS GMBH
6 04260160470044 in-tem® 503-02-US The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l 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)). ROTEM® TEM INNOVATIONS GMBH
7 04260160470020 delta System 200100-US The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l 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. ROTEM® TEM INNOVATIONS GMBH
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12 03663537008368 223701 223701 BIOPHEN LMWH Control Low HYPHEN BIOMED
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41 00847661004486 27101 27101 Liquichek D-dimer Control Level 1 (A processed human plasma assayed D-dimer control.) Liquichek BIO-RAD LABORATORIES, INC.
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