CORGENIX MEDICAL CORPORATION 13535 Corgenix Anti-Phosphatidylserine IgM Semi-Quantitative Test Kit (192 Well)

INTENDED USE For the detection and semi-quantitation of IgG anti-prothrombin (aPT) antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (e.g., antiphospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY OF THE TEST Antiphospholipid antibodies are a heterogeneous group of immunoglobulins (IgG, IgM, IgA) that bind to several anionic phospholipids (e.g., cardiolipin, phosphatidylserine), to phospholipid-protein complexes, and to certain proteins in the absence of anionic phospholipids. The REAADS aPT ELISA test kit uses purified human prothrombin as antigen to detect IgG anti-prothrombin antibodies in human serum or citrated plasma in the absence of other exogenous cofactors or phospholipids. High serum or plasma levels of aPT antibodies may add valuable information in the laboratory assessment of antiphospholipid antibodies.PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum/citrated plasma samples, calibrators and controls are incubated in microwells coated with purified human prothrombin. After the removal of unbound proteins by washing, antibodies specific for human IgG labeled with horseradish peroxidase (HRP) are added forming complexes with the prothrombin bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells. Results are obtained by reading the O.D. of each test well in a spectrophotometer. Calibrator sera are provided with the IgG anti-prothrombin antibody concentration. The user will run a single point calibration, dividing the concentration value of the calibrator sera by the O.D. value of the calibrator providing a conversion factor. The O.D. values of the other samples are multiplied by the conversion factor to obtain IgG anti-prothrombin antibody concentrations in G units. Refer to Product Package Insert.

Autoimmune EIA Anti-Phosphatidylserine IgM Test Kit

Autoimmune EIA Anti-Phosphatidylserine IgA Test Kit

Autoimmune EIA Anti-Phosphatidylserine IgG Test

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

The Stat Profile Prime Plus Blood Analyzer is a compact, whole blood critical care analyzer that provides rapid and comprehensive results. It measures blood gases, electrolytes, metabolites, and co-oximetry, delivering 32 calculated results. Featuring maintenance-free, replaceable cartridge technology and patented non-lysing co-oximetry, the analyzer produces a complete test panel in about one minute. It also offers bidirectional connectivity and a powerful onboard data management system for efficient data handling and integration

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 TESTThe 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.

INTENDED USE For the detection and semi-quantitation of IgG anti-prothrombin (aPT) antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (e.g., antiphospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY OF THE TEST Antiphospholipid antibodies are a heterogeneous group of immunoglobulins (IgG, IgM, IgA) that bind to several anionic phospholipids (e.g., cardiolipin, phosphatidylserine), to phospholipid-protein complexes, and to certain proteins in the absence of anionic phospholipids. The REAADS aPT ELISA test kit uses purified human prothrombin as antigen to detect IgG anti-prothrombin antibodies in human serum or citrated plasma in the absence of other exogenous cofactors or phospholipids. High serum or plasma levels of aPT antibodies may add valuable information in the laboratory assessment of antiphospholipid antibodies.PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum/citrated plasma samples, calibrators and controls are incubated in microwells coated with purified human prothrombin. After the removal of unbound proteins by washing, antibodies specific for human IgG labeled with horseradish peroxidase (HRP) are added forming complexes with the prothrombin bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells. Results are obtained by reading the O.D. of each test well in a spectrophotometer. Calibrator sera are provided with the IgG anti-prothrombin antibody concentration. The user will run a single point calibration, dividing the concentration value of the calibrator sera by the O.D. value of the calibrator providing a conversion factor. The O.D. values of the other samples are multiplied by the conversion factor to obtain IgG anti-prothrombin antibody concentrations in G units. Refer to Product Package Insert.

Autoimmune EIA Anti-Phosphatidylserine IgM Test Kit

Autoimmune EIA Anti-Phosphatidylserine IgA Test Kit

Autoimmune EIA Anti-Phosphatidylserine IgG Test