No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10629009061255 | FRABP0125 | 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 | ||
2 | 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 | ||
3 | 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 | ||
4 | 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 | ||
5 | 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 | ||
6 | 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 | ||
7 | 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 | ||
8 | 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 | ||
9 | 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 | ||
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 |
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 |
8 | 03663537043550 | 224201 | 224201 | BIOPHEN LMWH Control C4 | HYPHEN BIOMED | |
9 | 03663537043512 | 224401 | 224401 | BIOPHEN LMWH CONTROL LOW CII | HYPHEN BIOMED | |
10 | 03663537043505 | 224301 | 224301 | BIOPHEN LMWH CONTROL LOW CI | HYPHEN BIOMED | |
11 | 03663537042904 | 224101 | 224101 | BIOPHEN UFH Control C1 | HYPHEN BIOMED | |
12 | 03663537008368 | 223701 | 223701 | BIOPHEN LMWH Control Low | HYPHEN BIOMED | |
13 | 03663537008320 | 223405 | 223405 | BIOPHEN™ V-L Control Plasma | HYPHEN BIOMED | |
14 | 03663537008313 | 223301 | 223301 | BIOPHEN ABNORMAL CONTROL PLASMA | HYPHEN BIOMED | |
15 | 03663537008306 | 223201 | 223201 | BIOPHEN NORMAL CONTROL PLASMA | HYPHEN BIOMED | |
16 | 03663537008290 | 223101 | 223101 | BIOPHEN UFH Control Plasma | HYPHEN BIOMED | |
17 | 03663537008283 | 223001 | 223001 | BIOPHEN LMWH Control Plasma | HYPHEN BIOMED | |
18 | 03663537008276 | 222301 | 222301 | BIOPHEN UFH Calibrator | HYPHEN BIOMED | |
19 | 03663537008252 | 222101 | 222101 | BIOPHEN PLASMA CALIBRATOR | HYPHEN BIOMED | |
20 | 03663537008245 | 222001 | 222001 | BIOPHEN Heparin Calibrator | HYPHEN BIOMED | |
21 | 03663537007996 | 223901 | 223901 | BIOPHEN UFH CONTROL C2 | HYPHEN BIOMED | |
22 | 03663537007989 | 223801 | 223801 | BIOPHEN LMWH Control C3 | HYPHEN BIOMED | |
23 | 03607450006865 | 00686 | STA® - Quality HBPM/LMWH | DIAGNOSTICA STAGO | ||
24 | 03607450006780 | 00678 | STA® - System Control N + P | DIAGNOSTICA STAGO | ||
25 | 03607450006773 | 00677 | STA® - Coag Control (N + ABN) PLUS | DIAGNOSTICA STAGO | ||
26 | 03607450006766 | 00676 | STA® - Coag Control N + ABN | DIAGNOSTICA STAGO | ||
27 | 03607450005264 | 00526 | STA® - Liatest® Control N + P | DIAGNOSTICA STAGO | ||
28 | 03607450003819 | 00381 | STA® - Quality HNF/UFH | DIAGNOSTICA STAGO | ||
29 | 03607450002010 | 00201 | STA® - Control LA 1 + 2 | DIAGNOSTICA STAGO | ||
30 | 00885074184937 | 550-11 | CALCIUM CHLORIDE 5 ML | NA | MEDTRONIC, INC. | |
31 | 00859110005111 | 903se | 903se | Validate Heparin is intended for the quantitative determination of Calibration V Validate Heparin is intended for the quantitative determination of Calibration Verification/Linearity of the heparin anti-Xa activity on automated instruments | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
32 | 00859110005104 | 903st | 903st | Validate Heparin is intended for the quantitative determination of Calibration V Validate Heparin is intended for the quantitative determination of Calibration Verification/Linearity of the heparin anti-Xa activityon automated instruments | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
33 | 00859110005098 | 903il | 903il | Validate Heparin is intended for the quantitative determination of Calibration V Validate Heparin is intended for the quantitative determination of Calibration Verification/Linearity of the heparin anti-Xa activityon automated instruments | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
34 | 00859110005081 | 902se | 902se | Validate D-Dimer is intended for the quantitative determination of Calibration V Validate D-Dimer is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
35 | 00859110005074 | 902st | 902st | Validate D-Dimer is intended for the quantitative determination of Calibration V Validate D-Dimer is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
36 | 00859110005067 | 902il | 902il | Validate D-Dimer is intended for the quantitative determination of Calibration V Validate D-Dimer is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
37 | 00850201006208 | 840C | 840C | ACTICLOT Protein C Resistance control plasmas | BIOMEDICA ADI INC. | |
38 | 00847661004516 | 27102X | 27102X | Liquichek D-dimer Control MiniPak (A processed human plasma assayed D-dimer control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
39 | 00847661004509 | 27103 | 27103 | Liquichek D-dimer Control Level 3 (A processed human plasma assayed D-dimer control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
40 | 00847661004493 | 27102 | 27102 | Liquichek D-dimer Control Level 2 (A processed human plasma assayed D-dimer control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
41 | 00847661004486 | 27101 | 27101 | Liquichek D-dimer Control Level 1 (A processed human plasma assayed D-dimer control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
42 | 00847661004479 | 27100 | 27100 | Liquichek D-dimer Control Level Low (A processed human plasma assayed D-dimer control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
43 | 00847661001959 | 745X | 745X | Lyphochek Coagulation Control Level Trilevel MiniPak (A human plasma coagulatio Lyphochek Coagulation Control Level Trilevel MiniPak (A human plasma coagulation control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
44 | 00847661001898 | 598X | 598X | Lyphochek Hemostasis Control MiniPak (A human plasma hemostasis control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
45 | 00847661001041 | 599 | 599 | Lyphochek Hemostasis Control Level 3 (A human plasma hemostasis control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
46 | 00847661001034 | 598 | 598 | Lyphochek Hemostasis Control Level 2 (A human plasma hemostasis control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
47 | 00847661001027 | 597 | 597 | Lyphochek Hemostasis Control Level 1 (A human plasma hemostasis control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
48 | 00847661000792 | 746 | 746 | Lyphochek Coagulation Control Level 3 (A human plasma coagulation control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
49 | 00847661000785 | 745 | 745 | Lyphochek Coagulation Control Level 2 (A human plasma coagulation control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
50 | 00847661000778 | 744 | 744 | Lyphochek Coagulation Control Level 1 (A human plasma coagulation control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |