Other products from "IMMCO DIAGNOSTICS, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00845714004827 5170 5170 Enhanced Anti-RNA POL lll Antibody ELISA NYO Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody 2 Immco Diagnostics, Inc
2 00845714004186 2510 2510 Counterstain DBL,LKJ,MOB,DHN Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control,Antinuclea Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control,Antinuclear Antibody, Antigen, Control,Test System, Antineutrophil Cytoplasmic Antibodies (Anca),Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control 2 IMMCO DIAGNOSTIC
3 00845714004100 2284 2284 DFS-70 Positive Control DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control 2 Immco Diagnostics Inc.
4 00845714002427 5152A 5152A B2GP1 IgA ELISA MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) 2 Immco Diagnostics, Inc
5 00845714002199 2107 2107 IgA FITC Conjugate w/ Evans Blue MVM Autoantibodies, Endomysial(Tissue Transglutaminase) 2 IMMCO DIAGNOSTIC
6 00845714002045 1108 1108 ImmuGlo HEp-2 ELITE IFA DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control 2 Immco Diagnostics, Inc
7 00845714004391 1140-240X 1140-240X Anti-neutrophil cytoplasmic Antibody (ANCA) IFA Kit IMMCO DIAGNOSTICS
8 00845714004384 1140-240 1140-240 Anti-neutrophil cytoplasmic Antibody (ANCA) IFA Kit IMMCO DIAGNOSTICS
9 00845714004353 2308 2308 Serum Diluent MSV,LJM System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi),Antinuclear Antibody (Enzy System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi),Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls 2 IMMCO DIAGNOSTICS
10 00845714004339 2302-60 2302-60 Buffer Diluent LKJ Antinuclear Antibody, Antigen, Control 2 IMMCO DIAGNOSTICS
11 00845714004322 2302-375 2302-375 Buffer Diluent LKJ Antinuclear Antibody, Antigen, Control 2 IMMCO DIAGNOSTICS
12 00845714004315 2302 2302 Serum Diluent DBL,LKJ,MOB,DHN Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control,Antinuclea Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control,Antinuclear Antibody, Antigen, Control,Test System, Antineutrophil Cytoplasmic Antibodies (Anca),Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control 2 IMMCO DIAGNOSTICS
13 00845714004308 2301 2301 Phosphate Buffered Saline DBL,LKJ,MOB,DHN Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control,Antinuclea Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control,Antinuclear Antibody, Antigen, Control,Test System, Antineutrophil Cytoplasmic Antibodies (Anca),Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control 2 IMMCO DIAGNOSTICS
14 00845714004247 2308-1 2308-1 WASH BUFFER MVM,MSV,MST,MOB,LRM,LLL,LJM,DHR Autoantibodies, Endomysial(Tissue Transglutaminase),System,Test,Antibodies,B2 - Autoantibodies, Endomysial(Tissue Transglutaminase),System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi),Antibodies, Gliadin,Test System, Antineutrophil Cytoplasmic Antibodies (Anca),Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control,Extractable Antinuclear Antibody, Antigen And Control,Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls,System, Test, Rheumatoid Factor 2 IMMCO DIAGNOSTICS
15 00845714004193 2500LONG 2500LONG Coverslips DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control 2 IMMCO DIAGNOSTICS
16 00845714004179 2506 2506 Mounting Medium MVM,DBL,LKJ,MOB,DHN Autoantibodies, Endomysial(Tissue Transglutaminase),Multiple Autoantibodies, Ind Autoantibodies, Endomysial(Tissue Transglutaminase),Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control,Antinuclear Antibody, Antigen, Control,Test System, Antineutrophil Cytoplasmic Antibodies (Anca),Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control 2 IMMCO DIAGNOSTICS
17 00845714004162 2505 2505 Mounting Medium MVM,DBL,LKJ,MOB,DHN Autoantibodies, Endomysial(Tissue Transglutaminase),Multiple Autoantibodies, Ind Autoantibodies, Endomysial(Tissue Transglutaminase),Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control,Antinuclear Antibody, Antigen, Control,Test System, Antineutrophil Cytoplasmic Antibodies (Anca),Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control 2 IMMCO DIAGNOSTICS
18 00845714004001 2252 2252 cANCA Positive Control MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca) 2 IMMCO DIAGNOSTICS
19 00845714003974 2251 2251 ARA Positive Control DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control 2 IMMCO DIAGNOSTICS
20 00845714003967 2250G 2250G EMA (IgG) Positive Control MVM Autoantibodies, Endomysial(Tissue Transglutaminase) 2 IMMCO DIAGNOSTICS
21 00845714003943 2250 2250 EMA Positive Control MVM,DBL Autoantibodies, Endomysial(Tissue Transglutaminase),Multiple Autoantibodies, Ind Autoantibodies, Endomysial(Tissue Transglutaminase),Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control 2 IMMCO DIAGNOSTICS
22 00845714003851 2240 2240 pANCA Positive Control MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca) 2 IMMCO DIAGNOSTICS
23 00845714003776 2162-12 2162-12 cANCA Slide ethanol fixed MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca) 2 IMMCO DIAGNOSTICS
24 00845714003769 2162-10 2162-10 cANCA Slide MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca) 2 IMMCO DIAGNOSTICS
25 00845714003752 2162 2162 cANCA Slide MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca) 2 IMMCO DIAGNOSTICS
26 00845714003714 2217 2217 Pemphigold Positive DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control 2 IMMCO DIAGNOSTICS
27 00845714003707 2216 2216 Pemphigus Foliaceus Control DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control 2 IMMCO DIAGNOSTICS
28 00845714003677 2215 2215 nDNA Positive Control DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control 2 IMMCO DIAGNOSTICS
29 00845714003660 2214 2214 Pemphigus Vulgaris Positive Control DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control 2 IMMCO DIAGNOSTICS
30 00845714003653 2161 2161 Rat Kidney Slide DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control 2 IMMCO DIAGNOSTICS
31 00845714003646 2160 2160 Primate Smooth Muscle Slide DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control 2 IMMCO DIAGNOSTICS
32 00845714003608 2155-18 2155-18 Primate Esophagus (Distal) Slide MVM Autoantibodies, Endomysial(Tissue Transglutaminase) 2 IMMCO DIAGNOSTICS
33 00845714003592 2155 1/10 2155 1/10 Primate Esophagus (Distal) Slide MVM Autoantibodies, Endomysial(Tissue Transglutaminase) 2 IMMCO DIAGNOSTICS
34 00845714003585 2155-8 2155-8 Primate Esophagus Slide MVM Autoantibodies, Endomysial(Tissue Transglutaminase) 2 IMMCO DIAGNOSTICS
35 00845714003578 2155-1 2155-1 Primate Esophagus (Distal) Slide MVM Autoantibodies, Endomysial(Tissue Transglutaminase) 2 IMMCO DIAGNOSTICS
36 00845714003561 2155 2155 Primate Esophagus Slide DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control 2 IMMCO DIAGNOSTICS
37 00845714003554 2154 2154 Primate/Guinea Pig Esophagus Slide DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control 2 IMMCO DIAGNOSTICS
38 00845714003547 2152-10 2152-10 Mouse Kidney/Stomach/Liver Slide DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control 2 IMMCO DIAGNOSTICS
39 00845714003530 2150-21 2150-21 Hep-2 Cells Slide LKJ Antinuclear Antibody, Antigen, Control 2 IMMCO DIAGNOSTICS
40 00845714003479 2100X 2100X IgG FITC Conjugate MOB,DHN,DBL,LKJ Test System, Antineutrophil Cytoplasmic Antibodies (Anca),Antinuclear Antibody, Test System, Antineutrophil Cytoplasmic Antibodies (Anca),Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control,Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control,Antinuclear Antibody, Antigen, Control 2 IMMCO DIAGNOSTICS
41 00845714003462 2500 2500 Coverslips DBL,LKJ,MOB,DHN Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control,Antinuclea Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control,Antinuclear Antibody, Antigen, Control,Test System, Antineutrophil Cytoplasmic Antibodies (Anca),Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control 2 IMMCO DIAGNOSTICS
42 00845714003448 2167-8 2167-8 Mouse Kidney Slide LKJ Antinuclear Antibody, Antigen, Control 2 IMMCO DIAGNOSTICS
43 00845714003387 2186 2186 pANCA Slide MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca) 2 IMMCO DIAGNOSTICS
44 00845714003370 2189 2189 c+p ANCA COMBI Slide MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca) 2 IMMCO DIAGNOSTICS
45 00845714003363 2190 2190 Hep-2/Mouse Kidney/Stomach Slide DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control 2 IMMCO DIAGNOSTICS
46 00845714003332 2191 2191 Hep-2/Mouse Kidney Slide DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control 2 IMMCO DIAGNOSTICS
47 00845714003318 2200 2200 Negative Control DBL,LKJ,MOB,DHN Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control,Antinuclea Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control,Antinuclear Antibody, Antigen, Control,Test System, Antineutrophil Cytoplasmic Antibodies (Anca),Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control 2 IMMCO DIAGNOSTICS
48 00845714003257 2213 2213 Intercellular Positive DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control 2 IMMCO DIAGNOSTICS
49 00845714003240 2151-6 2151-6 Crithidia Luciliae Slide DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control 2 IMMCO DIAGNOSTICS
50 00845714003226 2150-6 2150-6 Hep-2 Cells Slide LKJ Antinuclear Antibody, Antigen, Control 2 IMMCO DIAGNOSTICS
Other products with the same Product Code "MID"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00855360006113 13534 13534 INTENDED USE Detection and semi-quantitation of anti-phosphatidylserine antibodi 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 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 Anti-Phosphatidylserine IgG Semi-Quantitative Test Kit (192 Well) CORGENIX MEDICAL CORPORATION
2 00855360006106 10206 10206 INTENDED USEDetection and semi-quantitation of IgA anti-phosphatidylserine (aPS) INTENDED USEDetection and semi-quantitation of IgA anti-phosphatidylserine (aPS) antibodies as an aid for assessingthe 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 TESTHigh 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 TESTThe 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. REAADS Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit (96 Well) CORGENIX MEDICAL CORPORATION
3 00855360006090 030-001 030-001 INTENDED USE Detection and semi-quantitation of anti-phosphatidylserine antibodi 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. REAADS Anti-Phosphatidylserine IgG/IgM Semi-Quantitative Test Kit (96 Well) CORGENIX MEDICAL CORPORATION
4 00855360006083 13530 13530 INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibod INTENDED USE For the detection and semi-quantitation of anti-cardiolipin 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 Anti-phospholipid antibodies are autoantibodies that react with most negatively charged phospholipids, including cardiolipin (CL). Anti-cardiolipin (aCL) antibodies are frequently found in patients with systemic lupus erythematosus (SLE). Elevated levels of aCL antibodies have been reported to be significantly associated with the presence of both venous and arterial thrombosis, thrombocytopenia, and recurrent fetal loss. The term “anti-phospholipid syndrome” (APS) has been introduced to describe patients who present these clinical manifestations. PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum samples, calibrator sera, and controls are incubated in cardiolipin coated microwells, allowing aCL antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human IgA labeled with horseradish peroxidase (HRP) are added forming complexes with the cardiolipin bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of 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 aCL antibodies. Results are obtained by reading the O.D. of each well with a spectrophotometer. Calibrator sera are provided, with the IgA aCL concentration expressed in APL units. Control and patient results are determined from the calibration curve. Refer to Package Insert. Corgenix Anti-Cardiolipin IgA Semi-Quantitative Test Kit (192 Well) CORGENIX MEDICAL CORPORATION
5 00855360006076 13529 13529 INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibod INTENDED USE For the detection and semi-quantitation of anti-cardiolipin 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 Anti-phospholipid antibodies are autoantibodies that react with most negatively charged phospholipids, including cardiolipin (CL). Anti-cardiolipin (aCL) antibodies are frequently found in patients with systemic lupus erythematosus (SLE). Elevated levels of aCL antibodies have been reported to be significantly associated with the presence of both venous and arterial thrombosis, thrombocytopenia, and recurrent fetal loss. The term “anti-phospholipid syndrome” (APS) has been introduced to describe patients who present these clinical manifestations. PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum samples, calibrator sera, and controls are incubated in cardiolipin coated microwells, allowing aCL antibodies present in the samples to react with the immobilized antigen. After removal of unbound serum proteins by washing, antibodies specific for human IgM labeled with horseradish peroxidase (HRP) are added forming complexes with the cardiolipin bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of aCL antibodies. Results are obtained by reading the O.D. of each well with a spectrophotometer. Calibrator sera are provided, with the IgM aCL concentrations expressed in MPL units. One MPL unit is equivalent to 1 μg/mL of an affinity purified standard IgM sample. Control and patient results are determined from the calibration curve. Refer to Package Insert. Corgenix Anti-Cardiolipin IgM Semi-Quantitative Test Kit (192 Well) CORGENIX MEDICAL CORPORATION
6 00855360006069 13525 13525 INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibod INTENDED USE For the detection and semi-quantitation of anti-cardiolipin 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 Anti-phospholipid antibodies are auto antibodies that react with most negatively charged phospholipids, including cardiolipin (CL). Anti-cardiolipin (aCL) antibodies are frequently found in patients with systemic lupus erythematosus (SLE). Elevated levels of aCL antibodies have been reported to be significantly associated with the presence of both venous and arterial thrombosis, thrombocytopenia, and recurrent fetal loss. The term “anti-phospholipid syndrome” (APS) has been introduced to describe patients who present these clinical manifestations.PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum samples, calibrator sera, and controls are incubated in cardiolipin coated microwells, allowing aCL antibodies present in the samples to react with the immobilized antigen. After removal of unbound serum proteins by washing, antibodies specific for human IgG labeled with horseradish peroxidase (HRP) are added forming complexes with the cardiolipin bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of aCL antibodies. Results are obtained by reading the O.D. of each well with a spectrophotometer. Calibrator sera are provided, with the IgG aCL concentrations expressed in GPL units. One GPL unit is equivalent to 1 μg/mL of an affinity purified standard IgG sample. Control and patient results are determined from the calibration curve. Refer to Package Insert. Corgenix Anti-Cardiolipin IgG Semi-Quantitative Test Kit (192 Well) CORGENIX MEDICAL CORPORATION
7 00855360006052 026-001 026-001 INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibod INTENDED USE For the detection and semi-quantitation of anti-cardiolipin 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 IGA TEST Anti-phospholipid antibodies are autoantibodies that react with most negatively charged phospholipids, including cardiolipin (CL). Anti-cardiolipin (aCL) antibodies are frequently found in patients with systemic lupus erythematosus (SLE). Elevated levels of aCL antibodies have been reported to be significantly associated with the presence of both venous and arterial thrombosis, thrombocytopenia, and recurrent fetal loss. The term “anti-phospholipid syndrome” (APS) has been introduced to describe patients who present these clinical manifestations. PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum samples, calibrator sera, and controls are incubated in cardiolipin coated microwells, allowing aCL antibodies present in the samples to react with the immobilized antigen. After removal of unbound serum proteins by washing, antibodies specific for human IgA labeled with horseradish peroxidase (HRP) are added forming complexes with the cardiolipin bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of 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 aCL antibodies. Results are obtained by reading the O.D. of each well with a spectrophotometer. Calibrator sera are provided, with the IgA aCL concentration expressed in APL units. The O.D. values of the controls and patient samples are multiplied by the conversion factor to obtain IgA aCL values, expressed in APL units. Control and patient results are determined from the calibration curve. Refer to Package Insert. REAADS IgA Anti-Cardiolipin Semi-Quantitative Test Kit (96-Well) CORGENIX MEDICAL CORPORATION
8 00850487007517 Cardiolipin G Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA) SeraQuest QUEST INTERNATIONAL, INC.
9 00850487007227 Cardiolipin G Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA) ReQuest QUEST INTERNATIONAL, INC.
10 00847865012997 SW4.1_1 6652165B Manual & CDs, APLS IgA IFU, SW4.1_v1, US Only BioPlex 2200 BIO-RAD LABORATORIES, INC.
11 00847865012980 SW4.1V1 6652065B Manual & CDs, APLS IgM IFU, SW4.1_v1 BioPlex 2200 BIO-RAD LABORATORIES, INC.
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32 00845714002823 2314 2314 WASH BUFFER IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC.
33 00845714002786 2316 2316 Stop Solution IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC.
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36 00845714001833 5118M 5118M ACA IgM ELISA IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC.
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41 00816879020182 FGA18 96 well ELISA for the detection of anti-cardiolipin antibodies in human serum Autostat II Anti-Cardiolipin Screen HYCOR BIOMEDICAL LLC
42 00816879020168 FGA16 96 well ELISA for the detection of anti-Cardiolipin IgM antibodies in human serum Autostat II Anti-Cardiolipin IgM HYCOR BIOMEDICAL LLC
43 00816879020151 FGA15 96 well ELISA for the detection of Anti-Cardiolipin IgG antibodies in human serum Autostat II Anti-Cardiolipin IgG HYCOR BIOMEDICAL LLC
44 00613745031002 800-3100 3100 The ImmunoWELL Cardiolipin Antibody (IgM) Test is an enzyme immunoassay (EIA) fo The ImmunoWELL Cardiolipin Antibody (IgM) Test is an enzyme immunoassay (EIA) for the quantitative detection of antibodies to cardiolipin antigen in serum and is used as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders. ImmunoWELL Cardiolipin (IgM) Test GENBIO
45 00613745030906 800-3090 3090 The ImmunoWELL Cardiolipin Antibody (IgG) Test is an enzyme immunoassay (EIA) fo The ImmunoWELL Cardiolipin Antibody (IgG) Test is an enzyme immunoassay (EIA) for the quantitative detection of antibodies to cardiolipin antigen in serum and is used as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders. ImmunoWELL Cardiolipin (IgG) Test GENBIO
46 B24235CAAHUE010 35-CAAHU-E01 35-CAAHU-E01 The Anti-Cardiolipin-A ELISA is a solid phase enzyme immunoassay employing highl The Anti-Cardiolipin-A ELISA is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human Beta-2-glycoprotein I (Beta-2-GPI) for the semiquantitative and qualitative detection of IgA antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and Beta-2-GPI which are only expressed when Beta-2-GPI interacts with cardiolipin. The assay is an aid in the diagnosis of systemic lupus erythematosus (SLE), primary and secondary anti-phospholipid syndrome (APS) and should be used in conjunction with other serological tests and clinical findings. Anti-Cardiolipin-A ELISA AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
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