Other products from "HELENA LABORATORIES CORPORATION"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 M52592330 9233 CFF IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) 2 Antiserum to Human Serum
2 M52590150 9015 JZR SUPPORT GELS 1 IEP Sponge Wicks (2/pkg)
3 M52558520 5852 JOZ SYSTEM, AUTOMATED PLATELET AGGREGATION 2 Plateletworks Combo-25 Kit
4 M5255526140 552614 JHO ELECTROPHORETIC SEPARATION, LIPOPROTEINS 1 SPIFE Vis Cholesterol Kit
5 M5255527030 552703 CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M) 2 SPIFE Nexus IFE-6 Antisera Kit
6 M525AQCHP0 AQC-HP JPA SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES 2 Actalyke QC Kit - AQC-HP
7 M52552920 5292 GGP TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY 2 Protein S ELISA Kit
8 M52551280 5128 GKA ABNORMAL HEMOGLOBIN QUANTITATION 2 Hemolysate Reagent
9 M52590140 9014 JJN APPARATUS, ELECTROPHORESIS, FOR CLINICAL USE 1 Zip Zone Sponge Wicks
10 M5258JF520010 8JF52001 JPA SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES 2 AggRAM Module (Domestic)
11 M52563000000 6300000 LXG EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE 1 Pipette, Variable Volume, 10-100 microliter
12 M52557700040 5770004 JBP ACTIVATED WHOLE BLOOD CLOTTING TIME 2 Actalyke XL, (CSA/CE), W/ Flash Memory
13 M52556510 5651 KHE REAGENT, OCCULT BLOOD 2 ColoCARE Office Pack
14 M52518200 1820 CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M) 2 V8 WASTE DRAWER PACK
15 M52592500 9250 CFF IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) 2 Antiserum to Human IgE
16 M5255526040 552604 CIN ELECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES 2 SPIFE Alkaline Phosphatase Gel Kit
17 M5255525970 552597 CFF IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) 2 Blade Applicator Kit, 12 Sample
18 M5255524710 552471 CEF ELECTROPHORETIC, PROTEIN FRACTIONATION 1 SPIFE SPE HI RES 20 KIT
19 M5255524570 552457 CFF IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) 2 SPIFE IgG IEF-10 Kit
20 M5255523040 552304 CEF ELECTROPHORETIC, PROTEIN FRACTIONATION 1 QUICKGEL SPE Gel Kit
21 M5255522890 552289 CFF IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) 2 SPIFE ULTRA IFE-6 ANTISERA KIT
22 M5255521640 552164 CFF IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) 2 SPIFE Ultra ImmunoFix-9 Antisera Kit
23 M5255521360 552136 CEF ELECTROPHORETIC, PROTEIN FRACTIONATION 1 QUICKGEL MODIFIED APPLICATOR BLADES AND DEEP WELL CUPS
24 M5255521250 552125 CFF IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) 2 SPIFE Ultra ImmunoFix-15 Antisera Kit
25 M5255519410 551941 JHO ELECTROPHORETIC SEPARATION, LIPOPROTEINS 1 SPIFE Vis Cholesterol Reagent Kit
26 M52553680 5368 GHR REAGENT, PLATELET AGGREGATION 2 Collagen Reagent
27 M52553410 5341 JPD HEMOGLOBIN A2 QUANTITATION 2 Beta-Thal HbA2 Quik Column Kit
28 M52553390 5339 JCM CONTROL, HEMOGLOBIN, ABNORMAL 2 Normal HbA2 Quik Column Control
29 M52551340 5134 JJT ENZYME CONTROLS (ASSAYED AND UNASSAYED) 1 CK/LD Isoenzyme Control (5 x 2 mL)
30 M52551270 5127 GKA ABNORMAL HEMOGLOBIN QUANTITATION 2 Hemolysate Reagent
31 M52551250 5125 GKA ABNORMAL HEMOGLOBIN QUANTITATION 2 Hemolysate Reagent
32 M52551020 5102 CIN ELECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES 2 Alkaline Phosphatase Indolyl Blue Reagent Kit
33 M52550930 5093 LXG EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE 1 Bufferizer
34 M52550900 5090 LXG EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE 1 Zip Zone Prep (1 x 60 mL)
35 M52550850 5085 KHE REAGENT, OCCULT BLOOD 2 ColoScreen-ES Take Home Pack
36 M52550830 5083 KHE REAGENT, OCCULT BLOOD 2 ColoScreen III 1000 Slide Pack
37 M52550820 5082 KHE REAGENT, OCCULT BLOOD 2 ColoScreen III Lab Pack
38 M52550050 5005 KEM AGENT, CLEARING 1 Clear Aid
39 M5255000910 500091 KHE REAGENT, OCCULT BLOOD ColoScreen Developer
40 M52540840 4084 JQW STATION, PIPETTING AND DILUTING, FOR CLINICAL USE 1 Super Z Applicator (8-sample)
41 M52536150 3615 GJG Pipette, Quantitative, Hematology 1 H-Pette II (No Blade, Metal Canula) (1000 pieces)
42 M52536120 3612 GJG Pipette, Quantitative, Hematology 1 H-Pette with Blade (1000 pieces)
43 M52534270 3427 LXG EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE 1 SPIFE Urine/CSF Protein Accessories (50 templates plus blotters)
44 M52534260 3426 JBD SYSTEM, ANALYSIS, ELECTROPHORETIC HEMOGLOBIN 2 QuickGel Accessory Kit
45 M52534250 3425 JJY Multi-analyte controls, all kinds (assayed) 1 SPE Abnormal Control (10 x 2 mL)
46 M52530580 3058 CIN ELECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES 2 TITAN GEL Alkaline Phosphatase Kit
47 M52530410 3041 CEF ELECTROPHORETIC, PROTEIN FRACTIONATION 1 TITAN GEL Serum Protein Kit
48 M52530240 3024 CEF ELECTROPHORETIC, PROTEIN FRACTIONATION 1 Titan III Cellulose Acetate (94 x 76 mm)
49 M52523190 2319 LXG EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE 1 SPIFE 4000 Applicator Blades
50 M52523050 2305 LXG EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE 1 SPIFE 4000 IFE Sample Trays
Other products with the same Product Code "GGP"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 05391521420916 T6003 TriniLIZE™ PAI-1 Antigen TCOAG IRELAND LIMITED
2 05391521420909 T6004 TriniLIZE™ PAI-1 Activity TCOAG IRELAND LIMITED
3 05391521420565 T2608 TriniCHROM™ Factor VIII:C TCOAG IRELAND LIMITED
4 05391521420466 T1602 TriniCLOT™ Protein S TCOAG IRELAND LIMITED
5 05391521420091 50710 Lyophilized Platelets TCOAG IRELAND LIMITED
6 05391521420077 50750 Ristocetin Cofactor Assay TCOAG IRELAND LIMITED
7 05051700005807 GT118.3 Human Protein C ‘NL’ NANORIDTM Radial Immunodiffusion Kit THE BINDING SITE GROUP LIMITED
8 G0561067301 106730 106730 vW Select Kit (Ristocetin Cofactor) BIO/DATA CORPORATION
9 G0561064261 106426 106426 vW Normal Control Plasma BIO/DATA CORPORATION
10 G0561030251 103025 103025 vW Factor Assay (Ristocetin Cofactor) BIO/DATA CORPORATION
11 G0561015951 3 X 4.0 mL 101595 Lyophilized Platelets BIO/DATA CORPORATION
12 G0561012701 101270 101270 vW Abnormal Control Plasma BIO/DATA CORPORATION
13 G0561012691 101269 101269 vW Normal Reference Plasma BIO/DATA CORPORATION
14 G0561012580 10mL 101258 Lyophilized Platelets BIO/DATA CORPORATION
15 03663537008238 221205 221205 BIOPHEN Protein C 5 HYPHEN BIOMED
16 03663537008221 221202 221202 BIOPHEN Protein C 2.5 HYPHEN BIOMED
17 03607450009484 00948 Asserachrom® tPA DIAGNOSTICA STAGO
18 03607450009460 00946 Asserachrom® Free Protein S DIAGNOSTICA STAGO
19 03607450009453 00945 Asserachrom® Total Protein S DIAGNOSTICA STAGO
20 03607450009439 00943 Asserachrom® IX:Ag DIAGNOSTICA STAGO
21 03607450009422 00942 Asserachrom® VWF:Ag DIAGNOSTICA STAGO
22 03607450007473 00747 STA® - Staclot® Protein C 1 DIAGNOSTICA STAGO
23 03607450007466 00746 STA® - Staclot® Protein S DIAGNOSTICA STAGO
24 03607450007374 00737 STA® - Staclot® Protein C 3 DIAGNOSTICA STAGO
25 03607450006711 00671 STA® - Stachrom® Protein C DIAGNOSTICA STAGO
26 03607450006599 00659 STA® - Stachrom® Antiplasmin DIAGNOSTICA STAGO
27 03607450005707 00570 Liatest® Protein S DIAGNOSTICA STAGO
28 03607450005165 00516 STA® - Liatest® Free Protein S 6 DIAGNOSTICA STAGO
29 00859394006095 90-480 90-480 Protein S Kit 80-160 DET ThromboTek PSe R 2 DIAGNOSTICS, INC.
30 00855360006267 10826 10826 INTENDED USE An enzyme-linked immunosorbent assay (ELISA) for the quantitative d INTENDED USE An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Von Willebrand Factor Activity (VWF:Act) in citrated human plasma. For In Vitro Diagnostic Use.SUMMARY OF THE TEST Von Willebrand Factor Antigen (VWF:Ag or Factor VIII-related protein) is a plasma protein found in circulation combined by non-covalent interactions with Factor VIII (FVIII:C), a pro-coagulant protein also known as the anti-hemophilic factor. Deficiency of FVIII causes classic hemophilia while deficiency of VWF causes von Willebrand disease. Von Willebrand Disease is characterized by a deficiency or defect of VWF. Greater than 70% of Von Willebrand disease patients have a type 1 deficiency while approximately 20% have a type II deficiency. The laboratory diagnosis of Von Willebrand disease may require both quantitative and qualitative (functional) determinations to differentiate the two predominant subtypes of the disease, type I and type II. The classification of Von Willebrand disease into subtypes is important in determining the course of clinical treatment. PRINCIPLE OF THE TEST The REAADS VWF:Act assay is a sandwich ELISA. A monoclonal capture antibody specific for the portion of VWF which binds platelets is coated to 96-microwell polystyrene plates. Diluted patient plasma is incubated in the wells. The plates are washed to remove unbound proteins and other plasma molecules. Bound antigen is quantitated using horseradish peroxidase (HRP) conjugated anti-human VWF detection antibody. Following incubation, unbound conjugate is removed by washing. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured in O.D. units with a spectrophotometer at 450 nm. Patient VWF:Act in relative percent concentration is determined against a curve made from the reference plasma provided with the kit. Refer to Product Package Insert. REAADS von Willebrand Factor Activity Test Kit CORGENIX MEDICAL CORPORATION
31 00855360006038 034-001 034-001 INTENDED USEAn enzyme-linked immunosorbent assay (ELISA) for the quantitative de INTENDED USEAn enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Von WillebrandFactor Antigen (VWF: Ag) in citrated human plasma. For In Vitro Diagnostic Use.SUMMARY THE TESTVon Willebrand Factor Antigen (VWF:Ag or Factor VIII-related protein) is a plasma protein found incirculation combined by non-covalent interactions with Factor VIII (FVIII:C), a pro-coagulant protein alsoknown as the anti-hemophilic factor. These two proteins show distinct biochemical and functionalproperties as well as different antigenic determinants; their plasma levels may vary independently ofeach other. Deficiency of FVIII causes classic hemophilia while deficiency of VWF causes VonWillebrand disease. VWF:Ag plays a very important role in hemostasis. The prevalence of Von Willebrand disease has been estimated to be 1-3% of thegeneral population. Approximately 80% of Von Willebrand disease patients have a type I deficiency.The laboratory diagnosis of Von Willebrand disease may require both quantitative and qualitative(functional) determinations.PRINCIPLE OF THE TESTREAADS VWF:Ag assay is a sandwich ELISA. A capture antibody specific for human VWF is coated to96-microwell polystyrene plates. Diluted patient plasma is incubated in the wells, allowing any availableVWF:Ag to bind to the anti-human VWF antibody on the microwell surface. The plates are washed toremove unbound proteins and other plasma molecules. Bound VWF:Ag is quantitated using horseradishperoxidase (HRP) conjugated anti-human VWF detection antibody. Following incubation, unboundconjugate is removed by washing. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogenperoxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured in opticaldensity (O.D.) units with a spectrophotometer at 450nm. Patient VWF:Ag in relative percentconcentration is determined against a curve made from the reference plasma provided with the kit. Refer to product package insert. REAADS von Willebrand Factor Antigen Test Kit CORGENIX MEDICAL CORPORATION
32 00855360006021 035-001 035-001 INTENDED USEAn enzyme-linked immunosorbent assay (ELISA) for the quantitative de INTENDED USEAn enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Protein C Antigen in citrated human plasma. For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE TESTProtein C deficiency, either congenital or acquired, may lead to serious thrombotic events such as thrombophlebitis, deep vein thrombosis, or pulmonary embolism. Patients with a congenital heterozygous deficiency may present with venous thrombosis in young adulthood, while patients with the rare homozygous deficiency present with massive thrombosis (purpura fulminans) during the neonatal period. The prevalence of Protein C deficiency in the general population has been estimated at 1 in 300. In younger patients (<40-45 years) with recurrent venous thrombosis, the frequency of Protein C deficiencies may be as high as 10 to 15%. A decreased Protein C activity in plasma may be the result of low concentrations and function (type I) or only low function (type II).PRINCIPLE OF THE TESTThe Protein C Antigen assay is a sandwich ELISA. A capture antibody specific for human Protein C is coated to 96-microwell polystyrene plates. Diluted patient plasma is incubated in the wells, allowing any available Protein C to bind to the anti-human Protein C antibody on the microwell surface. The plates are washed to remove unbound proteins and other plasma molecules. Bound Protein C is quantitated using horseradish peroxidase (HRP) conjugated anti-human Protein C detection antibody. Following incubation, unbound conjugate is removed by washing. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured in optical density (O.D.) units with a spectrophotometer at 450nm. Protein C Antigen relative percent concentrations in patient plasma are determined against a curve prepared from the reference plasma provided with the kit.Refer to Product Package Insert. REAADS Protein C Test Kit CORGENIX MEDICAL CORPORATION
33 00855360006014 051-001 051-001 INTENDED USEAn enzyme-linked immunosorbent assay (ELISA) for the quantitative de INTENDED USEAn enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Free Protein S Antigen in citrated human plasma. For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE PROTEIN S TESTProtein S is a vitamin K-dependent protein synthesized in the liver, vascular endothelium, and megakaryocytes, which plays an important physiologic role in the Protein C Anticoagulant System. This anticoagulant system is one of the major regulators of hemostasis by inhibiting clot formation and by promoting fibrinolysis. Protein S functions as a cofactor for activated Protein C on the vascular membrane to facilitate the degradation of clotting factors Va and VIIIa, down-regulating clot formation. In normal plasma approximately 40% of Protein S circulates as a free molecule, while 60% is complexed with C4b, a plasma protein of the classical complement pathway. Only Free Protein S is functionally active and able to bind to activated Protein C, while the complexed form of Protein S is not.Protein S deficiency, either congenital or acquired, may lead to serious thrombotic events such as thrombophlebitis, deep vein thrombosis, or pulmonary embolism. The prevalence of Protein S deficiency has been estimated to be less than 1 case per 300 in the general population. Two-thirds of patients with a congenital deficiency of Protein S (levels less than 50% of normal) may present with venous thrombosis in young adulthood. In young patients (<35 years) with a history of thrombosis, the prevalence may be as high as 15 to 18%. Acquired Protein S deficiency may be seen during pregnancy, oral contraceptive or oral anticoagulant therapy, liver disease, diabetes mellitus, postoperative complications, septicemia, and various inflammatory syndromes. A decreased Protein S activity in plasma may be the result of low concentrations or abnormal function of the Protein S molecule.Refer to Product Package Insert. REAADS Monoclonal Free Protein S Antigen CORGENIX MEDICAL CORPORATION
34 00855360006007 036-001 036-001 INTENDED USEAn enzyme-linked immunosorbent assay (ELISA) for the quantitative de INTENDED USEAn enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Total and Free Protein S Antigen in citrated human plasma. For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE PROTEIN S TESTProtein S is a vitamin K-dependent protein synthesized in the liver, vascular endothelium, and megakaryocytes, which plays an important physiologic role in the Protein C Anticoagulant System. This anticoagulant system is one of the major regulators of hemostasis by inhibiting clot formation and by promoting fibrinolysis. Protein S functions as a cofactor for activated Protein C on the vascular membrane to facilitate the degradation of clotting factors Va and VIIIa, downregulating clot formation. In normal plasma approximately 40% of Protein S circulates as a free molecule, while 60% is complexed with C4b, a plasma protein of the classical complement pathway. Only Free Protein S is functionally active and able to bind to activated Protein C, while the complexed form of Protein S is not.Protein S deficiency, either congenital or acquired, may lead to serious thrombotic events such as thrombophlebitis, deep vein thrombosis, or pulmonary embolism. The prevalence of Protein S deficiency has been estimated to be less than 1 case per 300 in the general population. Two-thirds of patients with a congenital deficiency of Protein S (levels less than 50% of normal) may present with venous thrombosis in young adulthood. In young patients (<35 years) with a history of thrombosis, the prevalence may be as high as 15 to 18%.7 Acquired Protein S deficiency may be seen during pregnancy, oral contraceptive or oral anticoagulant therapy, liver disease, diabetes mellitus, postoperative complications, septicemia and various inflammatory syndromes.8 A decreased Protein S activity in plasma may be the result of low concentrations or abnormal function of the Protein S molecule.Refer to Product Package Insert. REAADS Protein S Antigen Test kit CORGENIX MEDICAL CORPORATION
35 00850201006161 ACC-45 ACC-45 ACTICLOT C KIT BIOMEDICA ADI INC.
36 00850201006154 843L 843L ACTICLOT PROTEIN S BIOMEDICA ADI INC.
37 00850201006109 101201 101201 SPECTROLYSE PAI-1 BIOMEDICA ADI INC.
38 00850201006093 885 885 IMUBIND vWF ACTIVITY ELISA BIOMEDICA ADI INC.
39 00850201006048 822 822 IMUBIND PLASMA PAI-1 ELISA BIOMEDICA ADI INC.
40 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 CRYOcheck Factor VIII Chromogenic PRECISION BIOLOGIC INC
41 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. CRYOcheck™ FVIII Inhibitor Kit PRECISION BIOLOGIC INC
42 00843876000497 CSD C & S Diluent PRECISION BIOLOGIC INC
43 00843876000428 CCS-30 CRYOcheck™ Clot S™ PRECISION BIOLOGIC INC
44 00843876000411 CCS-15 CRYOcheck™ Clot S™ PRECISION BIOLOGIC INC
45 00843876000404 CCC-30 CRYOcheck™ Clot C™ PRECISION BIOLOGIC INC
46 00843876000398 CCC-15 CRYOcheck™ Clot C™ PRECISION BIOLOGIC INC
47 00842768039522 10873458 OPGL07 For the quantitative determination of free protein S antigen in human plasma col For the quantitative determination of free protein S antigen in human plasma collected from venous blood samplesin 3.2 % sodium citrate tubes on the BCS XP System, the SYSMEX CS-2500 analyzer and the SYSMEX CS-5100 analyzer. INNOVANCE Free PS Ag SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
48 00842768038211 10714565 OUBD39 Determination of ristocetin co-factor activity of von Willebrand factor in human Determination of ristocetin co-factor activity of von Willebrand factor in human plasma through platelet agglutination BC von Willebrand Reagent SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
49 00842768011917 10446500 OUVV17 Quantative determination of protein C activity as an aid in the diagnosis of inh Quantative determination of protein C activity as an aid in the diagnosis of inherited and acquired deficiencies Berichrom® Protein C SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
50 00842768011900 10446499 OUVV15 Quantative determination of protein C activity as an aid in the diagnosis of inh Quantative determination of protein C activity as an aid in the diagnosis of inherited and acquired deficiencies Berichrom® Protein C SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH