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 "MSV"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00855360006236 11854 11854 INTENDED USEAn enzyme-linked immunoassay (ELISA) for the detection of IgG antibo INTENDED USEAn enzyme-linked immunoassay (ELISA) for the detection of IgG antibodies to complexes formed byoxidized low-density lipoprotein (oxLDL) with β2-glycoprotein I (β2GPI) in individuals with systemic lupuserythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). For In Vitro Diagnostic Use Only.SUMMARY AND EXPLANATION OF THE ASSAYThe antiphospholipid syndrome (APS) is one of the most common causes of acquired hypercoagulability(thrombophilia) It is frequently diagnosed in the context of a systemic autoimmune disorder such asSLE (secondary APS), however, it may also occur in the absence of an obvious underlying disease(primary APS). Oxidative stress and oxLDL formation are common in patients with SLE and APS suggesting an important relationship between lipid peroxidation and clotting activation (hypercoagulability). The presence of circulating IgG anti-oxLDL-β2GPI antibodies seem to be etiologically important. PRINCIPLE OF THE TESTThis test is an indirect ELISA detecting IgG anti-oxLDL-β2GPI antibodies. Diluted serum samples, calibrator(s), and controls are incubated in microwells coated with the oxLDL- β2GPI complex. After the removal of unbound serum proteins by washing, anti-human IgG antibodies, labeled with horseradish peroxidase (HRP), are added. Following another wash, 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 IgG anti-oxLDL-β2GPI antibody. Results are obtained by reading the OD of each well in a spectrophotometer. Calibrator sera are provided, with the IgG anti-oxLDL-β2GPI antibody concentration expressed in G Units. A log-log regression analysis is performed with calibrator values plotted against calibrator mean O.D.’s. Controls and patient results are determined from the calibration curve. Refer to product package insert. Anti-AtherOxTM IgG Test Kit (OxLDL-B2GPI IgG Antibody) CORGENIX MEDICAL CORPORATION
2 00855360006199 13372 13372 INTENDED USE For the detection and semi-quantitation of IgA anti-β2GPl antibodie INTENDED USE For the detection and semi-quantitation of IgA anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY OF THE TEST Anti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. 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. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgA anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. 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 β2GPl bound antibodies. Following another wash 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-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgA anti-β2GPl antibody concentrations expressed in A units. Controls and patient results are determined from the calibration curve. Refer to product package insert. Corgenix Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit (192 Well) CORGENIX MEDICAL CORPORATION
3 00855360006182 13371 13371 INTENDED USE For the detection and semi-quantitation of IgM anti-β2GPl antibodie INTENDED USE For the detection and semi-quantitation of IgM anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY OF THE TEST Anti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. 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. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgM anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl.. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgM, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash 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-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgM anti-β2GPl antibody concentrations expressed in M units. Controls and patient results are determined from the calibration curve. Refer to Product package insert. Corgenix Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit (192 Well) CORGENIX MEDICAL CORPORATION
4 00855360006175 13370 13370 INTENDED USE For the detection and semi-quantitation of IgG anti-β2GPl antibodie INTENDED USE For the detection and semi-quantitation of IgG anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Use Only.SUMMARY AND EXPLANATION OF THE I TEST Anti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. 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. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgG anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome. PRINCIPLE OF THE TEST The test is s an indirect ELISA. Diluted serum/ plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. 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 β2GPl bound antibodies. Following another wash 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 intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgG anti-β2GPl antibody concentrations expressed in G units.. Controls and patient results are determined from the calibration curve. Refer to Product Package Insert. Corgenix Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit (192 Well) CORGENIX MEDICAL CORPORATION
5 00855360006168 038-001 038-001 INTENDED USEFor the detection and semi-quantitation of IgM anti-β2GPl antibodies INTENDED USEFor the detection and semi-quantitation of IgM anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY OF THE TESTAnti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionicphospholipids, including cardiolipin and phosphatidylserine. 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. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgM anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.PRINCIPLE OF THE TESTThe test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgM, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash 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-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgM anti-β2GPl antibody concentrations expressed in M units. Controls and patient results are determined from the calibration curve. Refer to Product Package Insert. REAADS Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit (96 Well) CORGENIX MEDICAL CORPORATION
6 00855360006151 037-001 037-001 INTENDED USEFor the detection and semi-quantitation of IgG anti-β2GPl antibodies INTENDED USEFor the detection and semi-quantitation of IgG anti-β2GPl antibodies in individuals with systemic lupuserythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Use Only.SUMMARY OF THE TESTAnti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. 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. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgG anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.PRINCIPLE OF THE TESTThe test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgG, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash 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-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgG anti-β2GPl antibody concentrations expressed in G units. Controls and patient results are determined from the calibration curve. Refer to Product Package Insert. REAADS Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit (96 Well) CORGENIX MEDICAL CORPORATION
7 00855360006144 039-001 039-001 INTENDED USEFor the detection and semi-quantitation of IgA anti-β2GPl antibodies INTENDED USEFor the detection and semi-quantitation of IgA anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Use Only.SUMMARY OF THE TESTAnti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. 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. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgA anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.PRINCIPLE OF THE TESTThe test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. 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 β2GPl bound antibodies. Following another wash 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-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgA anti-β2GPl antibody concentrations expressed in A units. Controls and patient results are determined from the calibration curve. Refer to Product Package Insert. REAADS Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit (96 Well) CORGENIX MEDICAL CORPORATION
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39 00816879020243 FGA24 96 well ELISA for the detection of Anti-B2-Glycoprotein I IgA antibodies in human serum Autostat II Anti-B2-Glycoprotein I IgA HYCOR BIOMEDICAL LLC
40 00816879020236 FGA23 96 well ELISA for the detection of Anti-B2-Glycoprotein I IgM antibodies in human serum Autostat II Anti-B2-Glycoprotein I IgM HYCOR BIOMEDICAL LLC
41 00816879020229 FGA22 96 well ELISA for the detection of Anti-B2-Glycoprotein I IgG antibodies in human serum Autostat II Anti-B2-Glycoprotein I IgG HYCOR BIOMEDICAL LLC
42 B24235B2SHUE010 35-B2SHU-E01 35-B2SHU-E01 Anti-Beta 2 Glycoprotein Screen ELISA is a solid phase enzyme immunoassay employ Anti-Beta 2 Glycoprotein Screen ELISA is a solid phase enzyme immunoassay employing native Beta-2glycoprotein I highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against Beta-2-glycoprotein I in human serum. Anti-Beta 2 Glycoprotein Screen ELISA AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
43 08426951298778 00009800015 00009800015 1. HemosIL Acustar ß2GP1-Domain1 Reagent Cartridge (Cat. No. 000098000162. 1 Re 1. HemosIL Acustar ß2GP1-Domain1 Reagent Cartridge (Cat. No. 000098000162. 1 Resuspension buffer (Cat. No. 00009800019) 3. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 1 (Cat. No. 00009800017):4. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 2 (Cat. 00009800018): HemosIL AcuStar Anti-B2GPI Domain 1 INSTRUMENTATION LABORATORY COMPANY
44 08426951289271 701250 1. 1 QUANTA Flash B2GP1 IgM Reagent Cartridge2. 1 QUANTA Flash B2GP1 IgM Calibr 1. 1 QUANTA Flash B2GP1 IgM Reagent Cartridge2. 1 QUANTA Flash B2GP1 IgM Calibrator 1 3. 1 QUANTA Flash B2GP1 IgM Calibrator 2 QUANTA Flash® B2GP1 IgM Reagents INOVA DIAGNOSTICS, INC.
45 08426951289264 701245 1 QUANTA Flash B2GP1 IgG Reagent Cartridge1 QUANTA Flash B2GP1 IgG Calibrator 1 1 QUANTA Flash B2GP1 IgG Reagent Cartridge1 QUANTA Flash B2GP1 IgG Calibrator 1 1 QUANTA Flash B2GP1 IgG Calibrator 2 QUANTA Flash® B2GP1 IgG Reagents INOVA DIAGNOSTICS, INC.
46 08426951289257 701240 1. 1 QUANTA Flash B2GP1 IgA Reagent Cartridge2. 1 QUANTA Flash B2GP1 IgA Calibra 1. 1 QUANTA Flash B2GP1 IgA Reagent Cartridge2. 1 QUANTA Flash B2GP1 IgA Calibrator 1 3. 1 QUANTA Flash B2GP1 IgA Calibrator 2 QUANTA Flash® B2GP1 IgA Reagents INOVA DIAGNOSTICS, INC.
47 08426950601951 701188 1. 1 QUANTA Flash ß2GP1-Domain1 Reagent Cartridge2. 1 Resuspension buffer 3. 1 T 1. 1 QUANTA Flash ß2GP1-Domain1 Reagent Cartridge2. 1 Resuspension buffer 3. 1 Transfer pipet4. 1 QUANTA Flash ß2GP1-Domain1 Calibrator 15. 1 QUANTA Flash ß2GP1-Domain1 Calibrator 2 QUANTA Flash® B2GP1-Domain 1Reagents INOVA DIAGNOSTICS, INC.
48 08426950596820 701243 1. 1 QUANTA Flash ß2GP1 IgA Reagent Cartridge2. 1 QUANTA Flash ß2GP1 IgA Calibra 1. 1 QUANTA Flash ß2GP1 IgA Reagent Cartridge2. 1 QUANTA Flash ß2GP1 IgA Calibrator 1 3. 1 QUANTA Flash ß2GP1 IgA Calibrator 2 QUANTA Flash® β2GPI IgA Reagents INOVA DIAGNOSTICS, INC.
49 08426950595816 708665.10 1. 10 B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL pre 1. 10 B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgG ELISA Control4. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator A5. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator B6. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator C7. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator D8. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator E9. 9x 50mL HRP Sample Diluent10. 10x 25mL HRP Wash Concentrate, 40x concentrate11. 10x 10mL 2 HRP IgG Conjugate, (goat), anti-human IgG12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid QUANTA Lite® β2GPI IgG ELISA Bulk Pack INOVA DIAGNOSTICS, INC.
50 08426950594659 708675.10 1. 10x B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL pr 1. 10x B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgA ELISA Control4. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator A5. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator B6. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator C7. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator D8. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator E9. 9x 50mL HRP Sample Diluent10. 10x 25mL HRP Wash Concentrate, 40x concentrate11. 10x 10mL HRP IgA Conjugate, (goat), anti-human IgA12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid QUANTA Lite® β2GPI IgA ELISA Bulk Pack INOVA DIAGNOSTICS, INC.