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 00843876000039 CCN10-10 GGN Plasma, Coagulation Control CRYOcheck™ Pooled Normal Plasma
8 00843876000022 CCN-15 GGN Plasma, Coagulation Control CRYOcheck™ Pooled Normal Plasma
9 00843876000015 CCN-10 GGN Plasma, Coagulation Control CRYOcheck™ Pooled Normal Plasma
10 00843876000428 CCS-30 GGP Test, Qualitative And Quantitative Factor Deficiency CRYOcheck™ Clot S™
11 00843876000411 CCS-15 GGP Test, Qualitative And Quantitative Factor Deficiency CRYOcheck™ Clot S™
12 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
13 00843876000473 CHK50-30 GIR Reagent, Russel Viper Venom CRYOcheck™ LA Check™
14 00843876000466 CHK80-10 GIR Reagent, Russel Viper Venom CRYOcheck™ LA Check™
15 00843876000459 CHK-40 GIR Reagent, Russel Viper Venom CRYOcheck™ LA Check™
16 00843876000442 CHK-10 GIR Reagent, Russel Viper Venom CRYOcheck™ LA Check™
17 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
18 00843876000220 FDP02-15 GJT Plasma, Coagulation Factor Deficient CRYOcheck™ Factor II Deficient Plasma
19 00843876000213 FDP02-10 GJT Plasma, Coagulation Factor Deficient CRYOcheck™ Factor II Deficient Plasma
20 00843876000176 CCWLP-10 GGC Control, Plasma, Abnormal CRYOcheck™ Weak Lupus Positive Control
21 00843876000169 CCWLP-05 GGC Control, Plasma, Abnormal CRYOcheck™ Weak Lupus Positive Control
22 00843876000152 CCLP-10 GGN,GGC Plasma, Coagulation Control,Control, Plasma, Abnormal CRYOcheck™ Lupus Positive Control
23 00843876000145 CCLP-05 GGN,GGC Plasma, Coagulation Control,Control, Plasma, Abnormal CRYOcheck™ Lupus Positive Control
24 00843876000091 ARP2-10 GGC,GGN Control, Plasma, Abnormal,Plasma, Coagulation Control CRYOcheck™ Abnormal 2 Reference Control
25 00843876000084 ARP1-10 GGN,GGC Plasma, Coagulation Control,Control, Plasma, Abnormal CRYOcheck™ Abnormal 1 Reference Control
26 00843876000077 ARP1-05 GGN,GGC Plasma, Coagulation Control,Control, Plasma, Abnormal CRYOcheck™ Abnormal 1 Reference Control
27 00843876000374 FDP12-15 GJT Plasma, Coagulation Factor Deficient CRYOcheck™ Factor XII Deficient Plasma
28 00843876000367 FDP12-10 GJT Plasma, Coagulation Factor Deficient CRYOcheck™ Factor XII Deficient Plasma
29 00843876000497 CSD GGP Test, Qualitative And Quantitative Factor Deficiency C & S Diluent
30 00843876000206 CCNRP-10 GGN Plasma, Coagulation Control CRYOcheck™ Normal Reference Plasma
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 08426951126538 0009800131 00009800131 1. Low HIT Control (Cat. No. 00009800132)2. High HIT Control (Cat. No. 00009800133): HemosIL Acustar HIT Controls INSTRUMENTATION LABORATORY COMPANY
2 08426951024032 0022550030 00022550030 HemosIL D-Dimer HS 500 Controls (Liquid) HemosIL D-Dimer HS 500 Controls (Liquid) INSTRUMENTATION LABORATORY COMPANY
3 08426950975397 00020014700 00020014700 HemosIL HIT-Ab(PF4-H) Controls HemosIL HIT-Ab(PF4-H) Controls INSTRUMENTATION LABORATORY COMPANY
4 08426950660675 00020014100 00020014100 HemosIL Abnormal Control 3 HemosIL Abnormal Control 3 INSTRUMENTATION LABORATORY COMPANY
5 08426950660668 00020014000 00020014000 HemosIL Abnormal Control 2 HemosIL Abnormal Control 2 INSTRUMENTATION LABORATORY COMPANY
6 08426950660651 00020013900 00020013900 HemosIL Normal Control 1 HemosIL Normal Control 1 INSTRUMENTATION LABORATORY COMPANY
7 08426950584933 00020013100 00020013100 HemosIL D-Dimer HS 500 Controls (Liquid) HemosIL D-Dimer HS 500 Controls (Liquid) INSTRUMENTATION LABORATORY COMPANY
8 08426950513735 00020012500 00020012500 HemosIL LA Positive Control HemosIL LA Positive Control INSTRUMENTATION LABORATORY COMPANY
9 08426950513728 00020012600 00020012600 HemosIL LA Negative Control HemosIL LA Negative Control INSTRUMENTATION LABORATORY COMPANY
10 08426950498032 0009802100 0009802100 HemosIL AcuStar D-Dimer Controls HemosIL AcuStar D-Dimer Controls INSTRUMENTATION LABORATORY COMPANY
11 08426950485629 00020010500 00020010500 HemosIL INR Validate HemosIL INR Validate INSTRUMENTATION LABORATORY COMPANY
12 08426950484745 00020011500 00020011500 HemosIL Factor V Deficient Plasma (10 X 1 mL) HemosIL Factor V Deficient Plasma (10 X 1 mL) INSTRUMENTATION LABORATORY COMPANY
13 08426950482970 00020500200 00020500200 HemosIL D-Dimer HS 500 Controls HemosIL D-Dimer HS 500 Controls INSTRUMENTATION LABORATORY COMPANY
14 08426950452751 06260060600 06260060600 GEM Check Coag Control-Normal for ACT-LR GEM Check Coag Control-Normal for ACT-LR INSTRUMENTATION LABORATORY COMPANY
15 08426950452744 06260060500 06260060500 GEM Check Coag Control-Normal for ACT GEM Check Coag Control-Normal for ACT INSTRUMENTATION LABORATORY COMPANY
16 08426950452737 06260060400 06260060400 GEM Check Coag Control-Normal for PT GEM Check Coag Control-Normal for PT INSTRUMENTATION LABORATORY COMPANY
17 08426950452713 06260061400 06260061400 GEM Check Coag Control-Abnormal for Citrate PT GEM Check Coag Control-Abnormal for Citrate PT INSTRUMENTATION LABORATORY COMPANY
18 08426950452706 06260061700 06260061700 GEM Check Coag Control-Abnormal for PT GEM Check Coag Control-Abnormal for PT INSTRUMENTATION LABORATORY COMPANY
19 08426950452690 06260061600 06260061600 GEM Check Coag Control-Normal for APTT GEM Check Coag Control-Normal for APTT INSTRUMENTATION LABORATORY COMPANY
20 08426950452683 06260061100 06260061100 GEM Check Coag Control-Normal for Citrate PT GEM Check Coag Control-Normal for Citrate PT INSTRUMENTATION LABORATORY COMPANY
21 08426950088653 06260060300 06260060300 GEM Check Coag Control-Abnormal for ACT GEM Check Coag Control-Abnormal for ACT INSTRUMENTATION LABORATORY COMPANY
22 08426950088646 06260060200 06260060200 GEM Check Coag Control-Abnormal for ACT-LR GEM Check Coag Control-Abnormal for ACT-LR INSTRUMENTATION LABORATORY COMPANY
23 08426950088639 06260060100 06260060100 GEM Check Coag Control-Abnormal for APTT GEM Check Coag Control-Abnormal for APTT INSTRUMENTATION LABORATORY COMPANY
24 08426950083597 82 3492 63 82 3492 63 Control Plasma LMW Heparin Control Plasma LMW Heparin INSTRUMENTATION LABORATORY COMPANY
25 08426950078999 00020003310 00020003310 HemosIL High Abnormal Control ASSAYED HemosIL High Abnormal Control ASSAYED INSTRUMENTATION LABORATORY COMPANY
26 08426950078982 00020003210 00020003210 HemosIL Low Abnormal Control ASSAYED HemosIL Low Abnormal Control ASSAYED INSTRUMENTATION LABORATORY COMPANY
27 08426950071068 00020003110 00020003110 HemosIL Normal Control ASSAYED HemosIL Normal Control ASSAYED INSTRUMENTATION LABORATORY COMPANY
28 08426950063179 00020008610 00020008610 HemosIL D-Dimer Controls HemosIL D-Dimer Controls INSTRUMENTATION LABORATORY COMPANY
29 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
30 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
31 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
32 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
33 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
34 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
35 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
36 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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