No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00842768039416 | 10873440 | B4265-37 | For coagulation tests and as a rinsing solution for the sample needles of the Sy For coagulation tests and as a rinsing solution for the sample needles of the Sysmex® CA Systems | KQJ | SYSTEM, FIBRINOGEN DETERMINATION | Dade® CA System Buffer | |
2 | 00842768028441 | 10385332 | LKPM | For use in daily maintenance of the IMMULITE® and IMMULITE® 1000 systems | JJQ | COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE | 1 | IMMULITE® Probe Cleaning Kit |
3 | 00842768028427 | 10385231 | L2PWSM | For use in the routine operation of the IMMULITE® 2000 and IMMULITE® 2500 Analyzers | JJQ | COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE | IMMULITE 2000/XPi Probe Wash Module | |
4 | 00842768017872 | 10446691 | OWZG23 | Quantitative determination of fibrinogen in plasma | KQJ | SYSTEM, FIBRINOGEN DETERMINATION | Multifibren® U | |
5 | 00842768017865 | 10446689 | OWZG19 | Quantitative determination of fibrinogen in plasma | KQJ | SYSTEM, FIBRINOGEN DETERMINATION | Multifibren® U | |
6 | 00842768017087 | 10873532 | OPOD05 | For quality control of the INNOVANCE® Heparin assay | GGN | Plasma, coagulation control | INNOVANCE Heparin UF Control 2 | |
7 | 00842768016134 | 10446085 | OQIO19 | N/T Protein Control SL/M is a medium level, multi-analyte control for use as acc N/T Protein Control SL/M is a medium level, multi-analyte control for use as accuracy and precision control in the determination of human serum proteins by immunonephelometry with the BN Systems | JJY | Multi-analyte controls, all kinds (assayed) | N/T Protein Control SL/M | |
8 | 00842768016110 | 10446089 | OQIP19 | N/T Protein Control SL/H is a high level, multi-analyte control for use as accur N/T Protein Control SL/H is a high level, multi-analyte control for use as accuracy and precision control in the determination of human serum proteins by immunonephelometry with the BN Systems | JJY | Multi-analyte controls, all kinds (assayed) | N/T Protein Control SL/H | |
9 | 00842768013065 | 10446632 | OWMG15 | Quantitative determination of thrombin/antithrombin III complex (TAT) in human plasma | JBQ | ANTITHROMBIN III QUANTITATION | 2 | Enzygnost® TAT micro |
10 | 00842768012945 | 10446620 | OWLD11 | Determination of heparin activity in plasma and for the monitoring of heparin therapy | KFF | ASSAY, HEPARIN | 2 | Berichrom® Heparin |
11 | 00842768011030 | 10446415 | OTXY13 | For the determination of the activity of coagulation factor X in human plasma by For the determination of the activity of coagulation factor X in human plasma by coagulometric methods | GJT | PLASMA, COAGULATION FACTOR DEFICIENT | Coagulation Factor X Deficient Plasma | |
12 | 00842768009976 | 10446316 | OSDF13 | For the determination of the activity of coagulation factor XI in human plasma b For the determination of the activity of coagulation factor XI in human plasma by coagulometric methods | GJT | PLASMA, COAGULATION FACTOR DEFICIENT | Coagulation Factor XI Deficient Plasma | |
13 | 00842768009761 | 10446295 | OSAR19 | Quantitative determination of IgA in human serum and plasma on BN Systems | CFN | METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M) | 2 | N Antisera to Human IgA |
14 | 00842768009747 | 10446293 | OSAR11 | Quantitative determination of IgA in human serum and plasma on BN Systems | CFN | METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M) | 2 | N Antisera to Human IgA |
15 | 00842768008153 | 10446136 | OQUB21 | Cleaning solution BN II, BN ProSpec® Systems and BCS® Systems | JZW | NEPHELOMETER | Cleaner SCS | |
16 | 00842768008054 | 10446127 | OQTC11 | Quantitative determination of soluble transferrin receptor (sTfR) in human serum Quantitative determination of soluble transferrin receptor (sTfR) in human serum and heparinized plasma on BN Systems | DDG | TRANSFERRIN, ANTIGEN, ANTISERUM, CONTROL | N Latex sTfR | |
17 | 00842768007477 | 10461887 | OQGP15 | LA 1 Screening Reagent. Simplified DRVV reagent to screen for the presence of Lu LA 1 Screening Reagent. Simplified DRVV reagent to screen for the presence of Lupus Anticoagulants | GIR | REAGENT, RUSSEL VIPER VENOM | LA 1 Screening Reagent | |
18 | 00842768007279 | 10446043 | OQDC13 | Assayed control for RF ASL and CRP assays on Siemens Systems | JJY | Multi-analyte controls, all kinds (assayed) | N/T Rheumatology Control SL/2 | |
19 | 00842768006876 | 10445990 | OPCD03 | For use as a low level assayed control for the quantitative measurement of low m For use as a low level assayed control for the quantitative measurement of low molecular weight heparin with Berichrom Heparin | GIZ | PLASMA, CONTROL, NORMAL | Berichrom® Heparin LMW Control 1 | |
20 | 00842768006845 | 10445987 | OPCA03 | For calibration of the Berichrom Heparin assay for measurement of low molecular For calibration of the Berichrom Heparin assay for measurement of low molecular weight heparin | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | Berichrom® Heparin LMW Calibrator | |
21 | 00842768006838 | 10445986 | OPBZ03 | For use as a high level assayed control for the quantitative measurement of unfr For use as a high level assayed control for the quantitative measurement of unfractionated heparin with Berichrom Heparin | GGC | CONTROL, PLASMA, ABNORMAL | Berichrom® Heparin UF Control 2 | |
22 | 00842768006715 | 10445973 | OPAX03 | Quantitative determination of homocysteine in human serum and plasma on BN II an Quantitative determination of homocysteine in human serum and plasma on BN II and BN ProSpec® Systems | LPS | URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM | 2 | N Latex HCY |
23 | 00842768006388 | 10445924 | KC735 | CYSC CON L is an assayed intralaboratory quality control for assessment of preci CYSC CON L is an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of the CYSC method on the Dimension Vista® System | JJY | Multi-analyte controls, all kinds (assayed) | DImension Vista® Cystatin C Control L (low) | |
24 | 00842768006340 | 10445920 | KC716 | PROT1 CON M is an assayed, mid-level, intralaboratory, multi-analyte quality con PROT1 CON M is an assayed, mid-level, intralaboratory, multi-analyte quality control for the assessment of precision and analytical bias on the Dimension Vista® System | JJY | Multi-analyte controls, all kinds (assayed) | DImension Vista® Protein 1 Control M (medium) | |
25 | 00842768004056 | 10445731 | B4244-10 | For use as control in citrated coagulation systems | GGC | CONTROL, PLASMA, ABNORMAL | Dade® Ci-Trol® Coagulation Control Level 1 | |
26 | 00842768006173 | 10445902 | K7054 | For the quantitative measurement of immunoglobulin E in human serum and plasma ( For the quantitative measurement of immunoglobulin E in human serum and plasma (heparin or EDTA) on the Dimension Vista® System | DGC | IGE, ANTIGEN, ANTISERUM, CONTROL | DImension Vista® Immunoglobulin E Flex® reagent cartridge | |
27 | 00842768006135 | 10445898 | K7046 | For the quantitative measurement of C-reactive protein in human serum and plasma For the quantitative measurement of C-reactive protein in human serum and plasma on the Dimension Vista® System | NQD | CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL | Dimension Vista hsCRP Flex reagent cartridge | |
28 | 00842768006128 | 10445897 | K7044 | For the quantitative measurement of total homocysteine in human serum and plasma For the quantitative measurement of total homocysteine in human serum and plasma on the Dimension Vista® System | LPS | URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM | DImension Vista® Homocysteine Flex® reagent cartridge | |
29 | 00842768003967 | 10445722 | B4233-60 | The DIMERTEST® Latex Assay is intended for the rapid qualitative or semiquantita The DIMERTEST® Latex Assay is intended for the rapid qualitative or semiquantitative evaluation of circulating derivatives of cross-linked fibrin degradation products (XL-FDP) in human plasma | DAP | FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL | 2 | Dade® DIMERTEST® Latex Assay |
30 | 00842768003929 | 10445718 | B4233-15SY | Quantitative determination of fibrinogen in human plasma | GFK | FIBRINOGEN DETERMINATION STANDARDS AND CONTROLS | 2 | Dade® Fibrinogen Determination Reagents |
31 | 00842768003905 | 10445716 | B4224-60 | Control in heparin assay procedures | KFF | ASSAY, HEPARIN | Dade® Ci-Trol® Heparin Control, High | |
32 | 00842768003899 | 10445715 | B4224-50 | Control in heparin assay procedures | KFF | ASSAY, HEPARIN | Dade® Ci-Trol® Heparin Control, Low | |
33 | 00630414992617 | 10459382 | B4132-1A | For differential staining in hematology that gives results similar to a Wright-G For differential staining in hematology that gives results similar to a Wright-Giemsa stain | KQC | STAINS, HEMATOLOGY | 1 | Diff-Quik™ Stain Set |
34 | 00630414285054 | 10873691 | OWTI15 | Quantitative determination of ADNase B in human serum on BN Systems | GTR | ANTIDEOXYRIBONUCLEASE, STREPTOCOCCUS SPP. | 1 | N Latex ADNase B (USA) |
35 | 00630414284996 | 10873685 | OQDC17 | Assayed control for RF, ASL and CRP assays on BN Systems | JJY | Multi-analyte controls, all kinds (assayed) | 1 | N/T Rheumatology Control SL/2 |
36 | 00630414237503 | 10873663 | OPJF05 | Assayed accuracy and precision controls in the determination of free light chain Assayed accuracy and precision controls in the determination of free light chains (FLC) type kappa and type lambda on BN Systems. | JJY | Multi-analyte controls, all kinds (assayed) | N FLC CONTROL SL2 | |
37 | 00630414237480 | 10873661 | OPJE05 | Assayed accuracy and precision controls in the determination of free light chain Assayed accuracy and precision controls in the determination of free light chains (FLC) type kappa and type lambda on BN Systems. | JJY | Multi-analyte controls, all kinds (assayed) | N FLC CONTROL SL1 | |
38 | 00630414023526 | 10873571 | B4233-17SY | Quantitative determination of fibrinogen in human plasma | GFK | FIBRINOGEN DETERMINATION STANDARDS AND CONTROLS | 2 | Dade® Fibrinogen Determination Reagents |
39 | 00630414002736 | 10465217 | OVLI012 | The BN ProSpec® is a system for the quantitative determination of proteins in se The BN ProSpec® is a system for the quantitative determination of proteins in serum, plasma, urine and CSF | JZW | NEPHELOMETER | 1 | BN ProSpec® System |
40 | 00842768028410 | 10385393 | LPWS2 | For use in the routine operation of the IMMULITE® and IMMULITE® 1000 Analyzers | JJQ | COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE | IMMULITE® Probe Wash Module | |
41 | 00842768018534 | 10445997 | OPCS05 | Quantitative determination of carbohydrate-deficient transferrin (CDT) in human Quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum on BN II and BN ProSpec® Systems | NAO | Test,carbohydrate deficient transferrin | 1 | N Latex CDT Kit |
42 | 00842768014222 | 10446232 | ORHO37 | Supplementary Reagent for coagulation tests | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | Calcium Chloride Solution | |
43 | 00842768013478 | 10446673 | OWWR17 | Determination of the functional activity of antithrombin III (AT III) in human plasma | JPE | ANTITHROMBIN III, TWO STAGE CLOTTING TIME ASSAY | 2 | Berichrom® Antithrombin III (A) |
44 | 00842768013461 | 10446672 | OWWR15 | Determination of the functional activity of antithrombin III (AT III) in human plasma | JPE | ANTITHROMBIN III, TWO STAGE CLOTTING TIME ASSAY | 2 | Berichrom® Antithrombin III (A) |
45 | 00842768012778 | 10446604 | OWHU21 | Qualitative detection or semi-quantitative determination of C-reactive protein ( Qualitative detection or semi-quantitative determination of C-reactive protein (CRP) in human serum | DCN | SYSTEM, TEST, C-REACTIVE PROTEIN | 2 | RapiTex® CRP |
46 | 00842768012686 | 10446595 | OWHG13 | Quantitative determination of Ig light chains, type kappa in human serum on BN Systems | DFH | KAPPA, ANTIGEN, ANTISERUM, CONTROL | 2 | N Antiserum to Human-Ig/L-chain, K-type |
47 | 00842768012297 | 10446534 | OVLC21 | The N Evaporation Cap 2.5ml is part of the BN ProSpec system. | JZW | NEPHELOMETER | N Evaporation Caps for Control Vials (2.5 mL) | |
48 | 00842768012174 | 10446521 | OVIC11 | The N Predilution Well is used for settings of dilutions of standards, controls and sera. | DEW | IGG, ANTIGEN, ANTISERUM, CONTROL | N Predilution Wells | |
49 | 00842768011443 | 10446458 | OUMU15 | Supplementary reagent for multiple protein assays on Siemens systems | CFN | METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M) | 2 | N Supplementary Reagent/Precipitation |
50 | 00842768011085 | 10446420 | OUAX41 | Qualitative detection or semi-quantitative determination of C-reactive protein ( Qualitative detection or semi-quantitative determination of C-reactive protein (CRP) in human serum | DCN | SYSTEM, TEST, C-REACTIVE PROTEIN | 2 | RapiTex® CRP |
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 |