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 "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.
12 00847865012973 SW4.1V1 6651975B APLS IgG, IgM and IgA Assay Protocol File CD, SW4.1_v1 US Only BioPlex 2200 BIO-RAD LABORATORIES, INC.
13 00847865012966 SW4.1V1 6651965B Manual & CDs, APLS IgG IFU, SW4.1_v1, US Only BioPlex 2200 BIO-RAD LABORATORIES, INC.
14 00847865012522 SW4_1 6651965A Manual & CDs, BioPlex 2200 APLS IgG IFU, SW4_v1, US Only BioPlex 2200 BIO-RAD LABORATORIES, INC.
15 00847865012515 SW4_1 6652065A Manual & CDs, APLS IgM IFU, SW4_v1, US Only BioPlex 2200 BIO-RAD LABORATORIES, INC.
16 00847865012508 SW4_1 6651975A APLS IgG, IgM and IgA Assay Protocol File CD, SW4_v1 BioPlex 2200 BIO-RAD LABORATORIES, INC.
17 00847865002998 SW4_1 6652165A Manual & CDs, APLS IgA IFU, SW4_v1, US Only BioPlex 2200 BIO-RAD LABORATORIES, INC.
18 00847865000710 6652150 6652150 APLS IgA Reagent Pack BioPlex 2200 BIO-RAD LABORATORIES, INC.
19 00847865000666 6652050 6652050 APLS IgM Reagent Pack BioPlex 2200 BIO-RAD LABORATORIES, INC.
20 00847865000604 6651950 6651950 APLS IgG Reagent Pack BioPlex 2200 BIO-RAD LABORATORIES, INC.
21 00847817018282 425-2160 425-2160 Autoimmune EIA Anti-Phosphatidylserine IgA Test Kit Autoimmune EIA BIO-RAD LABORATORIES, INC.
22 00847817018275 425-2140 425-2140 Autoimmune EIA Anti-Phosphatidylserine IgM Test Kit Autoimmune EIA BIO-RAD LABORATORIES, INC.
23 00847817018268 425-2120 425-2120 Autoimmune EIA Anti-Phosphatidylserine IgG Test Autoimmune EIA BIO-RAD LABORATORIES, INC.
24 00847817018251 425-2100 425-2100 Autoimmune EIA Anti-ß2 Glycoprotein I IgA Test Kit Autoimmune EIA BIO-RAD LABORATORIES, INC.
25 00847817018244 425-2080 425-2080 Autoimmune EIA Anti-?2 Glycoprotein I IgM Test Kit Autoimmune EIA BIO-RAD LABORATORIES, INC.
26 00847817018237 425-2060 425-2060 Autoimmune EIA Anti-ß2 Glycoprotein I IgG Test Kit Autoimmune EIA BIO-RAD LABORATORIES, INC.
27 00847817018220 425-2040 425-2040 Autoimmune EIA Anti-Cardiolipin IgA Test Kit Autoimmune EIA BIO-RAD LABORATORIES, INC.
28 00847817018213 425-2020 425-2020 Autoimmune EIA Anti-Cardiolipin IgM Test Kit Autoimmune EIA BIO-RAD LABORATORIES, INC.
29 00847817018206 425-2000 425-2000 Autoimmune EIA Anti-Cardiolipin IgG Test Kit Autoimmune EIA BIO-RAD LABORATORIES, INC.
30 00845714002953 5305 5305 Serum Diluent IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC.
31 00845714002922 2514 2514 TMB Substrate IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC.
32 00845714002823 2314 2314 WASH BUFFER IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC.
33 00845714002786 2316 2316 Stop Solution IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC.
34 00845714002229 5118S 5118S ACA Screen ELISA IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC.
35 00845714002212 5118A 5118A ACA IgA ELISA IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC.
36 00845714001833 5118M 5118M ACA IgM ELISA IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC.
37 00845714001826 5118G 5118G ACA IgG ELISA IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC.
38 00817273020297 720-520 "720-520 Measles IgG Test Kit" Diamedix DIAMEDIX CORPORATION
39 00817273020242 720-430 "720-430 anti-MPO (P-ANCA) IgG Test Kit" Diamedix DIAMEDIX CORPORATION
40 00817273020235 720-420 "720-420 anti-Cardiolipin IgATest Kit" Diamedix DIAMEDIX CORPORATION
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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