SEARCH RESULTS FOR: 【溦信88931766】i换脸张子枫11V4G最全所有视频资源全部作品合集.ldb(8048 results)
INTENDED USE
Detection and semi-quantitation of anti-phosphatidylserine antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.
SUMMARY AND EXPLANATION OF THE TEST
High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (i.e., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. These antibodies have been associated with an increased risk for recurrent arterial and venous thrombotic events, thrombocytopenia and fetal loss. Phosphatidylserine is a more physiologically relevant phospholipid due to its presence in cell membranes of endothelial cells and platelets.
PRINCIPLE OF THE TEST
The test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in phosphatidylserine coated microwells.β2-glycoprotein I is provided in the sample diluent. After the removal of unbound serum/ plasma proteins by washing, antibodies specific for human IgA, labeled with horseradish peroxidase (HRP), are added forming complexes with the phosphatidylserine bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-phosphatidylserine (aPS) antibodies. Results are obtained by reading the Optical density of each well in a spectrophotometer. Calibrator sera are provided with the IgA anti-phosphatidylserine antibody concentrations expressed in APS (IgA aPS) units traceable to the reference preparations of the Louisville Antiphospholipid Laboratory Control and patient results are determined from the calibration curve. Refer to Package Insert.
CORGENIX MEDICAL CORPORATION
13536
In Commercial Distribution
- 00855360006120 ()
13536
- Phosphatidylserine antibody IVD, kit, enzyme immunoassay (EIA)
INTENDED USE
Detection and semi-quantitation of anti-phosphatidylserine antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.
SUMMARY AND EXPLANATION OF THE TEST
High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (i.e., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. These antibodies have been associated with an increased risk for recurrent arterial and venous thrombotic events, thrombocytopenia and fetal loss. Phosphatidylserine is a more physiologically relevant phospholipid due to its presence in cell membranes of endothelial cells and platelets.
PRINCIPLE OF THE TEST
The test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in phosphatidylserine coated microwells. β2-glycoprotein I is provided in the sample diluent. After the removal of unbound serum/ plasma proteins by washing, antibodies specific for human IgG, labeled with horseradish peroxidase (HRP), are added forming complexes with the phosphatidylserine bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-phosphatidylserine (aPS) antibodies. Results are obtained by reading the Optical Density of each well in a spectrophotometer. Calibrator sera are provided with the IgG anti-phosphatidylserine antibody concentrations expressed in GPS (IgG aPS) units traceable to the reference preparations of the Louisville Antiphospholipid Laboratory Control and patient results are determined from the calibration curve. Refer to Package Insert.
CORGENIX MEDICAL CORPORATION
13534
In Commercial Distribution
- 00855360006113 ()
13534
- Phosphatidylserine antibody IVD, kit, enzyme immunoassay (EIA)
INTENDED USE
Detection and semi-quantitation of IgA anti-phosphatidylserine (aPS) antibodies as an aid for assessing
the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders
(anti-phospholipid syndrome). For In Vitro Diagnostic Use.
SUMMARY AND EXPLANATION OF THE TEST
High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. These antibodies have been associated with an increased risk for recurrent arterial and venous thrombotic events, thrombocytopenia, and fetal loss. Phosphatidylserine is a more physiologically relevant phospholipid due to its presence in cell membranes of endothelial cells and platelets.
PRINCIPLE OF THE TEST
The test is an indirect ELISA. Diluted serum/citrated plasma samples, calibrator sera, and controls are incubated in phosphatidylserine coated microwells. β2-glycoprotein I is provided in the sample diluent. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgA, labeled with horseradish peroxidase (HRP), are added forming complexes with the phosphatidylserine bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of IgA Antiphosphatidylserine (aPS) antibodies. Results are obtained by reading the O.D. (optical density or absorbance) of each well in a spectrophotometer. IgA calibrator sera are provided, expressed as APS (IgA anti-phosphatidylserine) units. Control and patient results are determined from the calibration curve. Refer to Package Insert.
CORGENIX MEDICAL CORPORATION
10206
In Commercial Distribution
- 00855360006106 ()
10206
- Phosphatidylserine antibody IVD, kit, enzyme immunoassay (EIA)
INTENDED USE
Detection and semi-quantitation of anti-phosphatidylserine antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.
SUMMARY AND EXPLANATION OF THE ANTI-PHOSPHATIDYLSERINE TEST
High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (i.e., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. These antibodies have been associated with an increased risk for recurrent arterial and venous thrombotic events, thrombocytopenia and fetal loss. Phosphatidylserine is a more physiologically relevant phospholipid due to its presence in cell membranes of endothelial cells and platelets.
PRINCIPLE OF THE TEST
The test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in phosphatidylserine coated microwells. β2-glycoprotein I is provided in the sample diluent. After the removal of unbound serum/plasma proteins by washing, antibodies specific for human IgG or IgM, labeled with horseradish peroxidase (HRP), are added forming complexes with the phosphatidylserine bound antibodies. Two enzyme-conjugated antibody solutions are provided, one specific for human IgG antibodies and one specific for human IgM antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-phosphatidylserine (aPS) antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided for both IgG and IgM antibody concentrations expressed in GPS or MPS units. Control and patient results are determined from the calibration curve. Refer to Package Insert.
CORGENIX MEDICAL CORPORATION
030-001
In Commercial Distribution
- 00855360006090 ()
030-001
- Phosphatidylserine antibody IVD, kit, enzyme immunoassay (EIA)
Designed for missions in the most remote and austere environments, the Fresh Whole Blood Transfusion Set contains essential items to collect and transfuse fresh whole blood in a compact sealed package. The set includes a donor module, blood collection bag and recipient module; that allow for donor collection and the ability to perform a transfusion procedure to the recipient.
Product Description
In remote areas and combat environments where definitive care may be too far away or inaccessible, transfusion of fresh whole blood may be the best option for management of hemorrhagic shock in casualties. Blood transfusions have been used successfully in military conflicts and other austere conditions to resuscitate trauma patients suffering from hemorrhagic shock. Developed with extensive research and feedback from the Armed Services Blood Program Office, the Fresh Whole Blood Transfusion Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood transfusion in a compact sealed package.
NOTE: Only personnel trained in blood collection, transfusion, and management of transfusion reactions should use this set.
Combat Capabilities
• Easily administered
• Simplifies training
• Compact lightweight
• Cost effective
Product Attributes
• 100% TAA compliant components (no waivers required)
• Donor and recipient specific modules
• Shelf life: 12 months
• Made in USA
Clinical Benefit
• Assembled in FDA registered facility.
• Adhesive blood bag label for recording donor information.
• EldonCard™: ABO/Rh blood-typing card for simple, accurate, and fast results.
• Re-sealable bag used to send all supplies back with casualty for retrospective testing.
Specifications
• NSN: 6515-01-657-4750
• PN: 80-801
• Single-use
• 12-month Shelf Life
o Does not contain natural rubber latex
• Available Direct and GSA
• 100% TAA Compliant
• Made i
Safeguard US Operating, LLC
1
Not in Commercial Distribution
- M689808010 ()
80-801
- Blood donor set, single-pack
- Blood transfusion set, non-exchange
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.
CORGENIX MEDICAL CORPORATION
10826
In Commercial Distribution
- 00855360006267 ()
10826
- von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, enzyme immunoassay (EIA)
INTENDED USE
An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Von Willebrand
Factor Antigen (VWF: Ag) in citrated human plasma. For In Vitro Diagnostic Use.
SUMMARY 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. These two proteins show distinct biochemical and functional
properties as well as different antigenic determinants; their plasma levels may vary independently of
each other. Deficiency of FVIII causes classic hemophilia while deficiency of VWF causes Von
Willebrand disease.
VWF:Ag plays a very important role in hemostasis. The prevalence of Von Willebrand disease has been estimated to be 1-3% of the
general 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 TEST
REAADS VWF:Ag assay is a sandwich ELISA. A capture antibody specific for human VWF is coated to
96-microwell polystyrene plates. Diluted patient plasma is incubated in the wells, allowing any available
VWF:Ag to bind to the anti-human VWF antibody on the microwell surface. The plates are washed to
remove unbound proteins and other plasma molecules. Bound VWF:Ag 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 optical
density (O.D.) units with a spectrophotometer at 450nm. Patient VWF:Ag in relative percent
concentration is determined against a curve made from the reference plasma provided with the kit. Refer to product package insert.
CORGENIX MEDICAL CORPORATION
034-001
In Commercial Distribution
- 00855360006038 ()
034-001
- Coagulation factor VIII-associated antigen IVD, kit, enzyme immunoassay (EIA)
INTENDED USE
An 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 TEST
Protein 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 TEST
The 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.
CORGENIX MEDICAL CORPORATION
035-001
In Commercial Distribution
- 00855360006021 ()
035-001
- Protein C IVD, kit, chromogenic