Other products from "PRECISION BIOLOGIC INC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00843876000268 FDP07-15 GJT Plasma, Coagulation Factor Deficient CRYOcheck™ Factor VII Deficient Plasma
2 00843876000312 FDP09-15 GJT Plasma, Coagulation Factor Deficient CRYOcheck™ Factor IX Deficient Plasma
3 00843876000305 FDP09-10 GJT Plasma, Coagulation Factor Deficient CRYOcheck™ Factor IX Deficient Plasma
4 00843876000251 FDP07-10 GJT Plasma, Coagulation Factor Deficient CRYOcheck™ Factor VII Deficient Plasma
5 00843876000381 FDPK-10 GJT Plasma, Coagulation Factor Deficient CRYOcheck™ Prekallikrein Deficient Plasma
6 00843876000435 PNP-10 GGW Test, Time, Partial Thromboplastin CRYOcheck™ Platelet Lysate
7 00843876000046 CCN-40 GGN Plasma, Coagulation Control CRYOcheck™ Pooled Normal Plasma
8 00843876000039 CCN10-10 GGN Plasma, Coagulation Control CRYOcheck™ Pooled Normal Plasma
9 00843876000022 CCN-15 GGN Plasma, Coagulation Control CRYOcheck™ Pooled Normal Plasma
10 00843876000015 CCN-10 GGN Plasma, Coagulation Control CRYOcheck™ Pooled Normal Plasma
11 00843876000428 CCS-30 GGP Test, Qualitative And Quantitative Factor Deficiency CRYOcheck™ Clot S™
12 00843876000411 CCS-15 GGP Test, Qualitative And Quantitative Factor Deficiency CRYOcheck™ Clot S™
13 00843876000503 CCIK08 The CRYOcheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction The CRYOcheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction with a factor VIII activity assay to enable performance of a modified Nijmegen-Bethesda assay using 3.2% citrated human plasma. It enables the determination of a functional FVIII inhibitor titer to aid in the clinical management of congenital hemophilia A in individuals aged 2 years and older. GGN,GGP Plasma, Coagulation Control,Test, Qualitative And Quantitative Factor Deficiency 2 CRYOcheck™ FVIII Inhibitor Kit
14 00843876000473 CHK50-30 GIR Reagent, Russel Viper Venom CRYOcheck™ LA Check™
15 00843876000466 CHK80-10 GIR Reagent, Russel Viper Venom CRYOcheck™ LA Check™
16 00843876000459 CHK-40 GIR Reagent, Russel Viper Venom CRYOcheck™ LA Check™
17 00843876000442 CHK-10 GIR Reagent, Russel Viper Venom CRYOcheck™ LA Check™
18 00843876000558 CCCF08 CCCF08 CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantita CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determination of factor VIII activity in 3.2% citrated human plasma. It is intended to be used in identifying factor VIII deficiency and as an aid in the management of hemophilia A in individuals aged 2 years and older. For in vitro diagnostic use GGP Test, Qualitative And Quantitative Factor Deficiency 2 CRYOcheck Factor VIII Chromogenic
19 00843876000220 FDP02-15 GJT Plasma, Coagulation Factor Deficient CRYOcheck™ Factor II Deficient Plasma
20 00843876000213 FDP02-10 GJT Plasma, Coagulation Factor Deficient CRYOcheck™ Factor II Deficient Plasma
21 00843876000176 CCWLP-10 GGC Control, Plasma, Abnormal CRYOcheck™ Weak Lupus Positive Control
22 00843876000169 CCWLP-05 GGC Control, Plasma, Abnormal CRYOcheck™ Weak Lupus Positive Control
23 00843876000152 CCLP-10 GGN,GGC Plasma, Coagulation Control,Control, Plasma, Abnormal CRYOcheck™ Lupus Positive Control
24 00843876000145 CCLP-05 GGN,GGC Plasma, Coagulation Control,Control, Plasma, Abnormal CRYOcheck™ Lupus Positive Control
25 00843876000091 ARP2-10 GGC,GGN Control, Plasma, Abnormal,Plasma, Coagulation Control CRYOcheck™ Abnormal 2 Reference Control
26 00843876000084 ARP1-10 GGN,GGC Plasma, Coagulation Control,Control, Plasma, Abnormal CRYOcheck™ Abnormal 1 Reference Control
27 00843876000077 ARP1-05 GGN,GGC Plasma, Coagulation Control,Control, Plasma, Abnormal CRYOcheck™ Abnormal 1 Reference Control
28 00843876000374 FDP12-15 GJT Plasma, Coagulation Factor Deficient CRYOcheck™ Factor XII Deficient Plasma
29 00843876000367 FDP12-10 GJT Plasma, Coagulation Factor Deficient CRYOcheck™ Factor XII Deficient Plasma
30 00843876000497 CSD GGP Test, Qualitative And Quantitative Factor Deficiency C & S Diluent
31 00843876000190 CCNRP-05 GGN Plasma, Coagulation Control CRYOcheck™ Normal Reference Plasma
32 00843876000107 CCA1-10 GGC,GGN Control, Plasma, Abnormal,Plasma, Coagulation Control CRYOcheck™ Abnormal 1 Control
33 00843876000404 CCC-30 GGP Test, Qualitative And Quantitative Factor Deficiency CRYOcheck™ Clot C™
34 00843876000398 CCC-15 GGP Test, Qualitative And Quantitative Factor Deficiency CRYOcheck™ Clot C™
35 00843876000541 CCLN-05 CCLN-05 Prepared from human source plasma and recommended as a negative control in assay Prepared from human source plasma and recommended as a negative control in assays for lupus anticoagulant. GGN Plasma, Coagulation Control CRYOcheck Lupus Negative Control
36 00843876000534 CCLN-10 CCLN-10 Prepared from human source plasma and recommended as a negative control in assay Prepared from human source plasma and recommended as a negative control in assays for lupus anticoagulant. GGN Plasma, Coagulation Control CRYOcheck Lupus Negative Control
37 00843876000060 RCN-10 GIZ Plasma, Control, Normal CRYOcheck™ Reference Control Normal
38 00843876000053 RCN-05 GIZ Plasma, Control, Normal CRYOcheck™ Reference Control Normal
39 00843876000336 FDP10-15 GJT Plasma, Coagulation Factor Deficient CRYOcheck™ Factor X Deficient Plasma
40 00843876000329 FDP10-10 GJT Plasma, Coagulation Factor Deficient CRYOcheck™ Factor X Deficient Plasma
41 00843876000244 FDP05-15 GJT Plasma, Coagulation Factor Deficient CRYOcheck™ Factor V Deficient Plasma
42 00843876000275 FDP08-10 GJT Plasma, Coagulation Factor Deficient CRYOcheck™ Factor VIII Deficient Plasma
43 00843876000299 FDP08-40 GJT Plasma, Coagulation Factor Deficient CRYOcheck™ Factor VIII Deficient Plasma
44 00843876000282 FDP08-15 GJT Plasma, Coagulation Factor Deficient CRYOcheck™ Factor VIII Deficient Plasma
45 00843876000480 SUR-10 GIR Reagent, Russel Viper Venom CRYOcheck™ LA Sure™
46 00843876000237 FDP05-10 GJT Plasma, Coagulation Factor Deficient CRYOcheck™ Factor V Deficient Plasma
47 00843876000138 CCLF-10 GGN Plasma, Coagulation Control CRYOcheck™ Low Fibrinogen Control
48 00843876000510 Hex LA Hex LA CRYOcheck Hex LA is for clinical laboratory use as a qualitative test kit intend CRYOcheck Hex LA is for clinical laboratory use as a qualitative test kit intended to aid in the detection of lupus anticoagulants (LA) in 3.2% citrated human plasma by the application of hexagonal phase phospholipids. CRYOcheck Hex LA should be used as an integrated test for lupus anticoagulant detection. For in vitro diagnostic use. The performance of this device has not been established in neonate and pediatric patient populations. GFO Activated Partial Thromboplastin 2 CRYOcheck Hex LA
49 00843876000183 APCR-05 GGN Plasma, Coagulation Control CRYOcheck™ APCR Positive Control
50 00843876000343 FDP11-10 GJT Plasma, Coagulation Factor Deficient CRYOcheck™ Factor XI Deficient Plasma
Other products with the same Product Code "GGN"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 07640175460020 502-22 502-22 Control plasma for assays aimed to determine the functional phenotype for activa Control plasma for assays aimed to determine the functional phenotype for activated protein C resistance caused by the Factor V Leiden mutation (FV:Q506). Pefakit DSM NUTRITIONAL PRODUCTS AG ZWEIGNIEDERLASSUNG PENTAPHARM
2 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
3 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
4 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
5 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
6 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
7 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
8 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
9 03663537043550 224201 224201 BIOPHEN LMWH Control C4 HYPHEN BIOMED
10 03663537043512 224401 224401 BIOPHEN LMWH CONTROL LOW CII HYPHEN BIOMED
11 03663537043505 224301 224301 BIOPHEN LMWH CONTROL LOW CI HYPHEN BIOMED
12 03663537042904 224101 224101 BIOPHEN UFH Control C1 HYPHEN BIOMED
13 03663537008368 223701 223701 BIOPHEN LMWH Control Low HYPHEN BIOMED
14 03663537008320 223405 223405 BIOPHEN™ V-L Control Plasma HYPHEN BIOMED
15 03663537008313 223301 223301 BIOPHEN ABNORMAL CONTROL PLASMA HYPHEN BIOMED
16 03663537008306 223201 223201 BIOPHEN NORMAL CONTROL PLASMA HYPHEN BIOMED
17 03663537008290 223101 223101 BIOPHEN UFH Control Plasma HYPHEN BIOMED
18 03663537008283 223001 223001 BIOPHEN LMWH Control Plasma HYPHEN BIOMED
19 03663537008276 222301 222301 BIOPHEN UFH Calibrator HYPHEN BIOMED
20 03663537008252 222101 222101 BIOPHEN PLASMA CALIBRATOR HYPHEN BIOMED
21 03663537008245 222001 222001 BIOPHEN Heparin Calibrator HYPHEN BIOMED
22 03663537007996 223901 223901 BIOPHEN UFH CONTROL C2 HYPHEN BIOMED
23 03663537007989 223801 223801 BIOPHEN LMWH Control C3 HYPHEN BIOMED
24 03607450006865 00686 STA® - Quality HBPM/LMWH DIAGNOSTICA STAGO
25 03607450006780 00678 STA® - System Control N + P DIAGNOSTICA STAGO
26 03607450006773 00677 STA® - Coag Control (N + ABN) PLUS DIAGNOSTICA STAGO
27 03607450006766 00676 STA® - Coag Control N + ABN DIAGNOSTICA STAGO
28 03607450005264 00526 STA® - Liatest® Control N + P DIAGNOSTICA STAGO
29 03607450003819 00381 STA® - Quality HNF/UFH DIAGNOSTICA STAGO
30 03607450002010 00201 STA® - Control LA 1 + 2 DIAGNOSTICA STAGO
31 00885074184937 550-11 CALCIUM CHLORIDE 5 ML NA MEDTRONIC, INC.
32 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.
33 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.
34 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.
35 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.
36 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.
37 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.
38 00850201006208 840C 840C ACTICLOT Protein C Resistance control plasmas BIOMEDICA ADI INC.
39 00847661004516 27102X 27102X Liquichek D-dimer Control MiniPak (A processed human plasma assayed D-dimer control.) Liquichek BIO-RAD LABORATORIES, INC.
40 00847661004509 27103 27103 Liquichek D-dimer Control Level 3 (A processed human plasma assayed D-dimer control.) Liquichek BIO-RAD LABORATORIES, INC.
41 00847661004493 27102 27102 Liquichek D-dimer Control Level 2 (A processed human plasma assayed D-dimer control.) Liquichek BIO-RAD LABORATORIES, INC.
42 00847661004486 27101 27101 Liquichek D-dimer Control Level 1 (A processed human plasma assayed D-dimer control.) Liquichek BIO-RAD LABORATORIES, INC.
43 00847661004479 27100 27100 Liquichek D-dimer Control Level Low (A processed human plasma assayed D-dimer control.) Liquichek BIO-RAD LABORATORIES, INC.
44 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.
45 00847661001898 598X 598X Lyphochek Hemostasis Control MiniPak (A human plasma hemostasis control.) Lyphochek BIO-RAD LABORATORIES, INC.
46 00847661001041 599 599 Lyphochek Hemostasis Control Level 3 (A human plasma hemostasis control.) Lyphochek BIO-RAD LABORATORIES, INC.
47 00847661001034 598 598 Lyphochek Hemostasis Control Level 2 (A human plasma hemostasis control.) Lyphochek BIO-RAD LABORATORIES, INC.
48 00847661001027 597 597 Lyphochek Hemostasis Control Level 1 (A human plasma hemostasis control.) Lyphochek BIO-RAD LABORATORIES, INC.
49 00847661000792 746 746 Lyphochek Coagulation Control Level 3 (A human plasma coagulation control.) Lyphochek BIO-RAD LABORATORIES, INC.
50 00847661000785 745 745 Lyphochek Coagulation Control Level 2 (A human plasma coagulation control.) Lyphochek BIO-RAD LABORATORIES, INC.