Other products from "PHADIA AB"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 07333066022307 34-2317-93 34-2317-93 Phadia Maintenance Solution Small JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE 1 Phadia Maintenance Solution Small
2 07333066019994 83-0008-01 83-0008-01 EliA APS Positive Control 250 JJY Multi-analyte controls, all kinds (assayed) 1 EliA APS Positive Control 250
3 07333066019987 83-0007-91 83-0007-91 EliA APS Positive Control 100 JJY Multi-analyte controls, all kinds (assayed) 1 EliA APS Positive Control 100
4 07333066019970 83-0006-71 83-0006-71 EliA Celiac Positive Control 250 JJY Multi-analyte controls, all kinds (assayed) 1 EliA Celiac Positive Control 250
5 07333066019963 34-2341-31 34-2341-31 ImmunoCAP Specific IgE Control H DHB System, test, radioallergosorbent (rast) immunological 2 ImmunoCAP Specific IgE Control H
6 07333066019949 34-2341-11 34-2341-11 ImmunoCAP Specific IgE Control L DHB System, test, radioallergosorbent (rast) immunological 2 ImmunoCAP Specific IgE Control L
7 07333066019857 34-2325-31 34-2325-31 ImmunoCAP Autoimmunity Specific IgG Sample Diluent JJY Multi-analyte controls, all kinds (assayed) 1 ImmunoCAP Autoimmunity Specific IgG Sample Diluent
8 07333066019840 34-2316-11 34-2316-11 ImmunoCAP Autoimmunity Specific IgG Sample Diluent JJY Multi-analyte controls, all kinds (assayed) 1 ImmunoCAP Autoimmunity Specific IgG Sample Diluent
9 07333066019826 34-2294-41 34-2294-41 ImmunoCAP Specific IgG Conjugate JJY Multi-analyte controls, all kinds (assayed) 1 ImmunoCAP Specific IgG Conjugate
10 07333066019628 10-9414-01 10-9414-01 Contains 2 vials of each IgG antibodies level (N: normal; L: low; H: high) for t Contains 2 vials of each IgG antibodies level (N: normal; L: low; H: high) for the ImmunoCAP Thyroid Peroxidase method. JJY Multi-analyte controls, all kinds (assayed) 1 ImmunoCAP Thyroid Peroxidase IgG Antibodies Control NLH
11 07333066014807 DECC055390 DECC055390 EliA GliadinDP IgG Well MST Antibodies, gliadin 2 EliA GliadinDP IgG Well
12 07333066017549 14-6016-01 14-6016-01 ImmunoCAP Allergen i216, Allergen component rApi m 5, Honey bee PUW System, test, radioallergosorbent (Rast) immunological, exempt allergens 2 ImmunoCAP Allergen i216, Allergen component rApi m 5, Honey bee
13 07333066017532 14-6015-01 14-6015-01 ImmunoCAP Allergen i215, Allergen component rApi m 3, Honey bee PUW System, test, radioallergosorbent (Rast) immunological, exempt allergens 2 ImmunoCAP Allergen i215, Allergen component rApi m 3, Honey bee
14 07333066014852 DECC056490 DECC056490 EliA M2 Well DBM ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL 2 EliA M2 Well
15 07333066014746 DECC055310 DECC055310 EliA ß2-Glycoprotein I IgA Well MSV System,test,antibodies,b2 - glycoprotein i (b2 - gpi) 2 EliA ß2-Glycoprotein I IgA Well
16 07333066014692 DECC055200 DECC055200 EliA Gliadin IgG Well MST Antibodies, gliadin 2 EliA Gliadin IgG Well
17 07333066013138 83-0008-51 83-0008-51 EliA IgM Conjugate 200 DHR SYSTEM, TEST, RHEUMATOID FACTOR 2 EliA IgM Conjugate 200
18 07333066013077 83-0007-21 83-0007-21 EliA Celiac Positive Control 100 JJY Multi-analyte controls, all kinds (assayed) 1 EliA Celiac Positive Control 100
19 07333066013060 83-0007-11 83-0007-11 EliA CCP Positive Control 100 NHX ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) 2 EliA CCP Positive Control 100
20 07333066012841 83-0003-41 83-0003-41 EliA IgA Curve Control Strip MVM Autoantibodies, endomysial(tissue transglutaminase) 2 EliA IgA Curve Control Strip
21 07333066012780 83-0002-81 83-0002-81 EliA IgA Conjugate MVM Autoantibodies, endomysial(tissue transglutaminase) EliA IgA Conjugate
22 07333066011615 34-2273-31 34-2273-31 ImmunoCAP Specific IgG Curve Control Strip JJY Multi-analyte controls, all kinds (assayed) 1 ImmunoCAP Specific IgG Curve Control Strip
23 07333066010496 14-5341-01 14-5341-01 ImmunoCAP Allergen f352, Allergen component rAra h 8 PR-10, Peanut DHB SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL 2 ImmunoCAP Allergen f352, Allergen component rAra h 8 PR-10, Peanut
24 07333066009902 14-5304-10 14-5304-10 ImmunoCAP Antigen RGm24, Stachybotrys atra MVU Reagents, specific, analyte 1 ImmunoCAP Antigen RGm24, Stachybotrys atra
25 07333066009841 14-5301-10 14-5301-10 ImmunoCAP Rare Allergen Rm226, Staphylococcal enterotoxin TSST MVU Reagents, specific, analyte 1 ImmunoCAP Rare Allergen Rm226, Staphylococcal enterotoxin TSST
26 07333066009193 14-5254-10 14-5254-10 ImmunoCAP Allergen f335, Lupine seed MVU Reagents, specific, analyte 1 ImmunoCAP Allergen f335, Lupine seed
27 07333066009094 14-5249-10 14-5249-10 ImmunoCAP Rare Allergen Rf332, Mint MVU Reagents, specific, analyte 1 ImmunoCAP Rare Allergen Rf332, Mint
28 07333066008424 14-5209-10 14-5209-10 ImmunoCAP Allergen Rf313, Anchovy MVU Reagents, specific, analyte 1 ImmunoCAP Allergen Rf313, Anchovy
29 07333066008363 14-5206-10 14-5206-10 ImmunoCAP Allergen Rfx21, Fruits MVU Reagents, specific, analyte 1 ImmunoCAP Allergen Rfx21, Fruits
30 07333066008288 14-5202-10 14-5202-10 ImmunoCAP Allergen Rm208, Chaetomium globosum MVU Reagents, specific, analyte 1 ImmunoCAP Allergen Rm208, Chaetomium globosum
31 07333066008059 14-5189-10 14-5189-10 ImmunoCAP Rare Allergen Rk209, Hexalhydrophtalic anhydrid MVU Reagents, specific, analyte 1 ImmunoCAP Rare Allergen Rk209, Hexalhydrophtalic anhydrid
32 07333066007953 14-5183-10 14-5183-10 ImmunoCAP Allergen Rtx10, Tree pollen MVU Reagents, specific, analyte 1 ImmunoCAP Allergen Rtx10, Tree pollen
33 07333066007496 14-5139-10 14-5139-10 ImmunoCAP Rare Allergen Rf298, Tragacanth MVU Reagents, specific, analyte 1 ImmunoCAP Rare Allergen Rf298, Tragacanth
34 07333066006925 14-5086-10 14-5086-10 ImmunoCAP Allergen Rf212, Mushroom (champignon) MVU Reagents, specific, analyte 1 ImmunoCAP Allergen Rf212, Mushroom (champignon)
35 07333066006642 14-5065-10 14-5065-10 ImmunoCAP Allergen Rf221, Coffee MVU Reagents, specific, analyte 1 ImmunoCAP Allergen Rf221, Coffee
36 07333066006628 14-5064-10 14-5064-10 ImmunoCAP Allergen Rf268, Clove MVU Reagents, specific, analyte 1 ImmunoCAP Allergen Rf268, Clove
37 07333066006574 14-5060-10 14-5060-10 ImmunoCAP Allergen Rf291, Cauliflower MVU Reagents, specific, analyte 1 ImmunoCAP Allergen Rf291, Cauliflower
38 07333066006352 14-5044-10 14-5044-10 ImmunoCAP Allergen Rf271, Anise MVU Reagents, specific, analyte 1 ImmunoCAP Allergen Rf271, Anise
39 07333066006147 14-5026-10 14-5026-10 ImmunoCAP Allergen wx209, Ambrosia sp. MVU Reagents, specific, analyte 1 ImmunoCAP Allergen wx209, Ambrosia sp.
40 07333066005768 14-4990-01 14-4990-01 ImmunoCAP Allergen f431, Allergen component nGly m 5 Beta-conglycinin, Soy DHB SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL 2 ImmunoCAP Allergen f431, Allergen component nGly m 5 Beta-conglycinin, Soy
41 07333066005713 14-4983-01 14-4983-01 ImmunoCAP Allergen w233, Allergen component nArt v 3 LTP, Mugwort DHB SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL 2 ImmunoCAP Allergen w233, Allergen component nArt v 3 LTP, Mugwort
42 07333066005638 14-4972-01 14-4972-01 ImmunoCAP Allergen g216, Allergen component nCyn d 1 Bermuda grass DHB SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL 2 ImmunoCAP Allergen g216, Allergen component nCyn d 1 Bermuda grass
43 07333066005539 14-4963-01 14-4963-01 ImmunoCAP Allergen f422, Allergen component rAra h 1 Peanut DHB SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL 2 ImmunoCAP Allergen f422, Allergen component rAra h 1 Peanut
44 07333066005508 14-4960-01 14-4960-01 ImmunoCAP Allergen f419, Allergen component rPru p 1 PR-10, Peach DHB SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL 2 ImmunoCAP Allergen f419, Allergen component rPru p 1 PR-10, Peach
45 07333066005386 14-4950-10 14-4950-10 ImmunoCAP Allergen Rw23, Yellow dock MVU Reagents, specific, analyte 1 ImmunoCAP Allergen Rw23, Yellow dock
46 07333066004556 14-4843-01 14-4843-01 ImmunoCAP Allergen f299, Sweet chestnut DHB SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL 2 ImmunoCAP Allergen f299, Sweet chestnut
47 07333066004488 14-4836-01 14-4836-01 ImmunoCAP Allergen f203, Pistachio DHB SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL 2 ImmunoCAP Allergen f203, Pistachio
48 07333066004327 14-4820-01 14-4820-01 ImmunoCAP Allergen f207, Clam DHB SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL 2 ImmunoCAP Allergen f207, Clam
49 07333066004303 14-4818-01 14-4818-01 ImmunoCAP Allergen f284, Turkey meat DHB SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL 2 ImmunoCAP Allergen f284, Turkey meat
50 07333066003801 14-4434-01 14-4434-01 ImmunoCAP Allergen f254, Plaice DHB SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL 2 ImmunoCAP Allergen f254, Plaice
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
8 00847865012997 SW4.1_1 6652165B Manual & CDs, APLS IgA IFU, SW4.1_v1, US Only BioPlex 2200 BIO-RAD LABORATORIES, INC.
9 00847865012980 SW4.1V1 6652065B Manual & CDs, APLS IgM IFU, SW4.1_v1 BioPlex 2200 BIO-RAD LABORATORIES, INC.
10 00847865012973 SW4.1V1 6651975B APLS IgG, IgM and IgA Assay Protocol File CD, SW4.1_v1 US Only BioPlex 2200 BIO-RAD LABORATORIES, INC.
11 00847865012966 SW4.1V1 6651965B Manual & CDs, APLS IgG IFU, SW4.1_v1, US Only BioPlex 2200 BIO-RAD LABORATORIES, INC.
12 00847865012522 SW4_1 6651965A Manual & CDs, BioPlex 2200 APLS IgG IFU, SW4_v1, US Only BioPlex 2200 BIO-RAD LABORATORIES, INC.
13 00847865012515 SW4_1 6652065A Manual & CDs, APLS IgM IFU, SW4_v1, US Only BioPlex 2200 BIO-RAD LABORATORIES, INC.
14 00847865012508 SW4_1 6651975A APLS IgG, IgM and IgA Assay Protocol File CD, SW4_v1 BioPlex 2200 BIO-RAD LABORATORIES, INC.
15 00847865002998 SW4_1 6652165A Manual & CDs, APLS IgA IFU, SW4_v1, US Only BioPlex 2200 BIO-RAD LABORATORIES, INC.
16 00847865000710 6652150 6652150 APLS IgA Reagent Pack BioPlex 2200 BIO-RAD LABORATORIES, INC.
17 00847865000666 6652050 6652050 APLS IgM Reagent Pack BioPlex 2200 BIO-RAD LABORATORIES, INC.
18 00847865000604 6651950 6651950 APLS IgG Reagent Pack BioPlex 2200 BIO-RAD LABORATORIES, INC.
19 00847817018282 425-2160 425-2160 Autoimmune EIA Anti-Phosphatidylserine IgA Test Kit Autoimmune EIA BIO-RAD LABORATORIES, INC.
20 00847817018275 425-2140 425-2140 Autoimmune EIA Anti-Phosphatidylserine IgM Test Kit Autoimmune EIA BIO-RAD LABORATORIES, INC.
21 00847817018268 425-2120 425-2120 Autoimmune EIA Anti-Phosphatidylserine IgG Test Autoimmune EIA BIO-RAD LABORATORIES, INC.
22 00847817018251 425-2100 425-2100 Autoimmune EIA Anti-ß2 Glycoprotein I IgA Test Kit Autoimmune EIA BIO-RAD LABORATORIES, INC.
23 00847817018244 425-2080 425-2080 Autoimmune EIA Anti-?2 Glycoprotein I IgM Test Kit Autoimmune EIA BIO-RAD LABORATORIES, INC.
24 00847817018237 425-2060 425-2060 Autoimmune EIA Anti-ß2 Glycoprotein I IgG Test Kit Autoimmune EIA BIO-RAD LABORATORIES, INC.
25 00847817018220 425-2040 425-2040 Autoimmune EIA Anti-Cardiolipin IgA Test Kit Autoimmune EIA BIO-RAD LABORATORIES, INC.
26 00847817018213 425-2020 425-2020 Autoimmune EIA Anti-Cardiolipin IgM Test Kit Autoimmune EIA BIO-RAD LABORATORIES, INC.
27 00847817018206 425-2000 425-2000 Autoimmune EIA Anti-Cardiolipin IgG Test Kit Autoimmune EIA BIO-RAD LABORATORIES, INC.
28 00845714004353 2308 2308 Serum Diluent IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC.
29 00845714004247 2308-1 2308-1 WASH BUFFER IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC.
30 00845714002939 2513 2513 Enzyme Substrate IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC.
31 00845714002793 2310 2310 Stop Solution IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC.
32 00845714002458 5152S 5152S B2GP1 Screen ELISA Immco DIagnostics, Inc. IMMCO DIAGNOSTICS, INC.
33 00845714002441 5152M 5152M B2GP1 IgM ELISA Immco Diagnostics, Inc. IMMCO DIAGNOSTICS, INC.
34 00845714002434 5152G 5152G B2GP1 IgG ELISA Immco DIagnostics, Inc. IMMCO DIAGNOSTICS, INC.
35 00845714002427 5152A 5152A B2GP1 IgA ELISA Immco Diagnostics, Inc IMMCO DIAGNOSTICS, INC.
36 00845714000645 1152M 1152M Anti-B2-GP1 IgG Antibody ELISA IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC.
37 00845714000638 1152G 1152G Anti-B2-GP1 IgG Antibody ELISA IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC.
38 00817273020402 720-830 "720-830 anti-β2 Glycoprotein I IgG/IgM Test Kit" Diamedix DIAMEDIX CORPORATION
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.