| 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 |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 08426950595632 | 701198 | 1. 1 QUANTA Flash Centromere Reagent Cartridge2. 1 Resuspension buffer 3. 1 Transfer pipet | QUANTA Flash® Centromere Reagents | INOVA DIAGNOSTICS, INC. | |
| 2 | 08426950593744 | 708525 | 1. 1x ssDNA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pred 1. 1x ssDNA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ssDNA ELISA Low Positive4. 1 x1.2mL prediluted ssDNA ELISA High Positive5. 1 x50mL HRP Sample Diluent6. 1 x25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid" | QUANTA Lite® ssDNA ELISA | INOVA DIAGNOSTICS, INC. | |
| 3 | 08426950544128 | 708770 | (CENP-A & CENP-B)1.1x Centromere ELISA microwell plate (12-1 x 8 wells), with ho (CENP-A & CENP-B)1.1x Centromere ELISA microwell plate (12-1 x 8 wells), with holder2.1x 1.2mL prediluted ELISA Negative Control 3.1x 1.2mL prediluted Centromere ELISA Low Positive4.1x 1.2mL prediluted Centromere ELISA High Positive5.1x 50mL HRP Sample Diluent6.1 x25mL HRP Wash Concentrate, 40x concentrate7.1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8.1x 10mL TMB Chromogen9.1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® Centromere ELISA | INOVA DIAGNOSTICS, INC. | |
| 4 | 07340058410509 | FAID200 | FAID200 | DIASTAT ENA Profile | EURO-DIAGNOSTICA AB | |
| 5 | 07333066014845 | DECC056370 | DECC056370 | EliA Scl-70S Well | EliA Scl-70S Well | PHADIA AB |
| 6 | 07333066014586 | DECC055070 | DECC055070 | EliA Jo-1 Well | EliA Jo-1 Well | PHADIA AB |
| 7 | 07333066014579 | DECC055060 | DECC055060 | EliA Scl-70 Well | EliA Scl-70 Well | PHADIA AB |
| 8 | 05391516747165 | 2337770 | 2337770 | Captia™ Histone | Trinity Biotech | CLARK LABORATORIES, INC. |
| 9 | 05391516743778 | 2337370 | 2337370 | Captia™ Sm/RNP | Trinity Biotech | CLARK LABORATORIES, INC. |
| 10 | 05391516743761 | 2337270 | 2337270 | Captia™ Smith (Sm) | Trinity Biotech | CLARK LABORATORIES, INC. |
| 11 | 05391516743747 | 2337070 | 2337070 | Captia™ SSA (Ro) | Trinity Biotech | CLARK LABORATORIES, INC. |
| 12 | 04260157080638 | ORG600 | ORG600 | ANA Detect is an ELISA test system for the qualitative measurement of IgG class ANA Detect is an ELISA test system for the qualitative measurement of IgG class autoantibodies against SS-A-52 (Ro-52), SS-A-60 (Ro-60), SS-B (La), RNP/Sm, RNP-70, RNP-A, RNP-C, Sm-BB, Sm-D, Sm-E, Sm-F, Sm-G, Scl-70, Jo-1, dsDNA, ssDNA, ssDNA, polynucleosomes, mononucleosomes, histone complex, histone H1, histone H2A, histone H2B, histone 3, histone H4, Pm-Scl-100 and centromere B in human serum or plasma samples. This product is intended for professional in vitro diagnostic use only as an aid in the diagnosis of certain systematic rheumatic diseases. | ANA DETECT | ORGENTEC DIAGNOSTIKA GMBH |
| 13 | 04260157080102 | ORG513 | ORG513 | ANTI-JO-1 IS AN EILSA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS ANTI-JO-1 IS AN EILSA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST JO-1 IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY. | ANTI-JO-1 | ORGENTEC DIAGNOSTIKA GMBH |
| 14 | 04260157080096 | ORG512 | ORG512 | ANTI-SCL-70 IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLAS ANTI-SCL-70 IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SCL-70 IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PRFESSIONAL IN VITRO DIAGNOSTIC USE ONLY. | ANTI-SCI-70 | ORGENTEC DIAGNOSTIKA GMBH |
| 15 | 04260157080089 | ORG511 | ORG511 | ANTI-RPN/SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLAS ANTI-RPN/SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST RNP/SM IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY. | ANTI-RPN/SM | ORGENTEC DIAGNOSTIKA GMBH |
| 16 | 04260157080072 | ORG510 | ORG510 | ANTI-SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AU ANTI-SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SM IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY. | ANTI-SM | ORGENTEC DIAGNOSTIKA GMBH |
| 17 | 04260157080065 | ORG509 | ORG509 | ANTI-SS-B IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS ANTI-SS-B IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SS-B (La) IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY. | ANTI-SS-B | ORGENTEC DIAGNOSTIKA GMBH |
| 18 | 04260157080058 | ORG508 | ORG508 | ANTI-SS-A IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS ANTI-SS-A IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SS-A (52 AND 60kDa) IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY. | ANTI-SS-A | ORGENTEC DIAGNOSTIKA GMBH |
| 19 | 04250289503013 | 7113US | 7113US | AESKULISA Jo-1 is a solid phase enzyme immunoassay with recombinant human histid AESKULISA Jo-1 is a solid phase enzyme immunoassay with recombinant human histidyltRNA-synthetase (HRS) for the quantitative and qualitative detection of antibodies against Jo-1 (named after the prototype patient) in human serum. Human sera with anti-Jo-1 antibodies solely recognize HRS of higher eukaryotes and react with highest affinity with the human enzyme. The assay is a tool in the diagnosis of polymyositis and dermatomyositis. | AESKULISA® Jo-1 | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 20 | 04250289503006 | 7112US | 7112US | AESKULISA Cenp-B is a solid phase enzyme immunoassay employing purified recombin AESKULISA Cenp-B is a solid phase enzyme immunoassay employing purified recombinant human 80 kDa centromere protein B (Cenp-B) for the quantitative and qualitative detection of IgG antibodies against Cenp-B in human serum. The assay ensures the highest specificity and sensitivity for the detection of antibodies against centromere protein B, which serves as an aid in the diagnosis of systemic sclerosis and CREST syndrome. | AESKULISA® Cenp-B | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 21 | 04250289502993 | 7111US | 7111US | AESKULISA Scl-70 is a solid phase enzyme immunoassay with human recombinant 70 k AESKULISA Scl-70 is a solid phase enzyme immunoassay with human recombinant 70 kDa fragment of DNA topoisomerase I for the quantitative and qualitative detection of antibodies against Scl-70 (70 kDa scleroderma antigen) in human serum. The assay is a tool in the differential diagnosis of systemic sclerosis. | AESKULISA® Scl-70 | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 22 | 04250289502986 | 7110US | 7110US | AESKULISA SS-B is a solid phase enzyme immunoassay employing human recombinant L AESKULISA SS-B is a solid phase enzyme immunoassay employing human recombinant La-antigen/ SS-B for the quantitative and qualitative detection of antibodies against Laantigen / SS-B in human serum. The assay is a tool in the diagnosis of Sjögren`s syndrome (SS) and systemic lupus erythematosus (SLE). | AESKULISA® SS-B | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 23 | 04250289502979 | 7107US | 7107US | AESKULISA SS-A is a solid phase enzyme immunoassay for the quantitative and qual AESKULISA SS-A is a solid phase enzyme immunoassay for the quantitative and qualitative detection of antibodies against Ro/ SS-A in human serum. The assay employs human Ro/SS-A antigen composed of highly purified native 60kDa and recombinant human 52 kDa Ro/SS-A protein. Anti-SS-A antibodies are species-specific (directed against human protein only) and preferentially react with the native 60kDa molecule where as most antibodies to the 52 kDa protein prefer the denatured molecule. The assay is a tool in the diagnosis of Sjögren`s syndrome (SS) and systemic lupus erythematosus (SLE). | AESKULISA® SS-A | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 24 | 04250289502962 | 7106US | 7106US | AESKULISA Sm is a solid phase enzyme immunoassay with highly purified native Smi AESKULISA Sm is a solid phase enzyme immunoassay with highly purified native Smith antigen (Sm) from human eukaryotic cells (HeLa) for the quantitative and qualitative detection of antibodies against Sm in human serum. Anti-Sm antibodies recognize specific conformational epitopes only accessible on native human Sm. The assay is a tool in the differential diagnosis of systemic lupus erythematosus (SLE). | AESKULISA® Sm | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 25 | 04250289502955 | 7105US | 7105US | AESKULISA snRNP-C is a solid phase enzyme immunoassay for the quantitative and q AESKULISA snRNP-C is a solid phase enzyme immunoassay for the quantitative and qualitative detection of antibodies against the snRNP complex in human serum. The assay employs native human U1-snRNP complex highly purified from the cell-line HeLa. The U1-snRNP complex comprises the Smith antigen (Sm) and RNPs, the 70kDa U1specific protein plus protein A and C. The assay is a tool for the diagnosis of mixed connective tissue diseases (MCTD) and systemic lupus erythematosus (SLE) | AESKULISA® snRNP-C | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 26 | 04250289502948 | 7104US | 7104US | AESKULISA U1-70 is a solid phase enzyme immunoassay employing recombinant human AESKULISA U1-70 is a solid phase enzyme immunoassay employing recombinant human 70 kDa protein of the U1-snRNP complex for the quantitative and qualitative detection of antibodies against the 70 kDa U1-RNP in human serum. The assay is a tool in the diagnosis of mixed connective tissue diseases (MCTD) and systemic lupus erythematosus (SLE). | AESKULISA® U1-70 | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 27 | 04250289502931 | 7103US | 7103US | AESKULISA ENA-6Pro is a solid phase enzyme immunoassay for the separate semiquan AESKULISA ENA-6Pro is a solid phase enzyme immunoassay for the separate semiquantitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. The wells are coated with recombinant SS-B, SS-A 52 kDa, Scl 70, Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is a tool in the differential diagnosis of systemic rheumatic diseases. | AESKULISA® ENA-6Pro | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 28 | 04250289502917 | 7101US | 7101US | AESKULISA ANA-8Pro is a solid phase enzyme immunoassay for the separate qualitat AESKULISA ANA-8Pro is a solid phase enzyme immunoassay for the separate qualitative detection of IgG antibodies against eight cellular and nuclear antigens in human serum. The wells are separately coated with recombinant 70 kDa U1 snRNP, SS-B, SS-A 52 kDa, Scl 70, centromere protein B (CenpB), Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is a tool in the differential diagnosis of systemic rheumatic diseases. | AESKULISA® ANA-8Pro | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 29 | 04250289500555 | 3113 | AESKULISA Jo-1 is a solid phase enzyme immunoassay with recombinant human histid AESKULISA Jo-1 is a solid phase enzyme immunoassay with recombinant human histidyltRNA-synthetase (HRS) for the quantitative and qualitative detection of antibodies against Jo-1 (named after the prototype patient) in human serum. Human sera with anti-Jo-1 antibodies solely recognize HRS of higher eukaryotes and react with highest affinity with the human enzyme. The assay is a tool in the diagnosis of polymyositis and dermatomyositis. | AESKULISA® Jo-1 | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 30 | 04250289500548 | 3112 | AESKULISA Cenp-B is a solid phase enzyme immunoassay employing purified recombin AESKULISA Cenp-B is a solid phase enzyme immunoassay employing purified recombinant human 80 kDa centromere protein B (Cenp-B) for the quantitative and qualitative detection of IgG antibodies against Cenp-B in human serum. The assay ensures the highest specificity and sensitivity for the detection of antibodies against centromere protein B, which serves as an aid in the diagnosis of systemic sclerosis and CREST syndrome. | AESKULISA® Cenp-B | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 31 | 04250289500531 | 3111 | AESKULISA Scl-70 is a solid phase enzyme immunoassay with human recombinant 70 k AESKULISA Scl-70 is a solid phase enzyme immunoassay with human recombinant 70 kDa fragment of DNA topoisomerase I for the quantitative and qualitative detection of antibodies against Scl-70 (70 kDa scleroderma antigen) in human serum. The assay is a tool in the differential diagnosis of systemic sclerosis. | AESKULISA® Scl-70 | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 32 | 04250289500524 | 3110 | AESKULISA SS-B is a solid phase enzyme immunoassay employing human recombinant L AESKULISA SS-B is a solid phase enzyme immunoassay employing human recombinant La-antigen/ SS-B for the quantitative and qualitative detection of antibodies against Laantigen / SS-B in human serum. The assay is a tool in the diagnosis of Sjögren`s syndrome (SS) and systemic lupus erythematosus (SLE). | AESKULISA® SS-B | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 33 | 04250289500494 | 3107 | AESKULISA SS-A is a solid phase enzyme immunoassay for the quantitative and qual AESKULISA SS-A is a solid phase enzyme immunoassay for the quantitative and qualitative detection of antibodies against Ro/ SS-A in human serum. The assay employs human Ro/SS-A antigen composed of highly purified native 60kDa and recombinant human 52 kDa Ro/SS-A protein. Anti-SS-A antibodies are species-specific (directed against human protein only) and preferentially react with the native 60kDa molecule where as most antibodies to the 52 kDa protein prefer the denatured molecule. The assay is a tool in the diagnosis of Sjögren`s syndrome (SS) and systemic lupus erythematosus (SLE). | AESKULISA® SS-A | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 34 | 04250289500487 | 3106 | AESKULISA Sm is a solid phase enzyme immunoassay with highly purified native Smi AESKULISA Sm is a solid phase enzyme immunoassay with highly purified native Smith antigen (Sm) from human eukaryotic cells (HeLa) for the quantitative and qualitative detection of antibodies against Sm in human serum. Anti-Sm antibodies recognize specific conformational epitopes only accessible on native human Sm. The assay is a tool in the differential diagnosis of systemic lupus erythematosus (SLE). | AESKULISA® Sm | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 35 | 04250289500470 | 3105 | AESKULISA snRNP-C is a solid phase enzyme immunoassay for the quantitative and q AESKULISA snRNP-C is a solid phase enzyme immunoassay for the quantitative and qualitative detection of antibodies against the snRNP complex in human serum. The assay employs native human U1-snRNP complex highly purified from the cell-line HeLa. The U1-snRNP complex comprises the Smith antigen (Sm) and RNPs, the 70kDa U1specific protein plus protein A and C. The assay is a tool for the diagnosis of mixed connective tissue diseases (MCTD) and systemic lupus erythematosus (SLE) | AESKULISA® snRNP-C | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 36 | 04250289500463 | 3104 | AESKULISA U1-70 is a solid phase enzyme immunoassay employing recombinant human AESKULISA U1-70 is a solid phase enzyme immunoassay employing recombinant human 70 kDa protein of the U1-snRNP complex for the quantitative and qualitative detection of antibodies against the 70 kDa U1-RNP in human serum. The assay is a tool in the diagnosis of mixed connective tissue diseases (MCTD) and systemic lupus erythematosus (SLE). | AESKULISA® U1-70 | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 37 | 04250289500456 | 3103 | AESKULISA ENA-6Pro is a solid phase enzyme immunoassay for the separate semiquan AESKULISA ENA-6Pro is a solid phase enzyme immunoassay for the separate semiquantitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. The wells are coated with recombinant SS-B, SS-A 52 kDa, Scl 70, Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is a tool in the differential diagnosis of systemic rheumatic diseases. | AESKULISA® ENA-6Pro | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 38 | 04250289500425 | 3101 | AESKULISA ANA-8Pro is a solid phase enzyme immunoassay for the separate qualitat AESKULISA ANA-8Pro is a solid phase enzyme immunoassay for the separate qualitative detection of IgG antibodies against eight cellular and nuclear antigens in human serum. The wells are separately coated with recombinant 70 kDa U1 snRNP, SS-B, SS-A 52 kDa, Scl 70, centromere protein B (CenpB), Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is a tool in the differential diagnosis of systemic rheumatic diseases. | AESKULISA® ANA-8Pro | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 39 | 04049016124917 | DL 1590-6401-9 G | EUROLINE ENA Profile 9 Ag (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 40 | 04049016124900 | DL 1590-1601-9 G | EUROLINE ENA Profile 9 Ag (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 41 | 04049016084785 | DL 1590-6401-4 G | EUROLINE ENA ProfilePlus 4 (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 42 | 04049016083139 | DL 1590-1601-4 G | EUROLINE ENA ProfilePlus 4 (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 43 | 04049016027065 | EA 1611-9601 G | Anti-Centromeres ELISA (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 44 | 04049016026976 | EA 1590-9601-8 G | ANA Screen ELISA (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 45 | 04048474035810 | EIA-3581 | EIA-3581 | Anti-Jo-1 ELISA is a test system for the quantitative measurement of class autoa Anti-Jo-1 ELISA is a test system for the quantitative measurement of class autoantibodies against Jo-1 in human serum or plasma. | Anti-Jo-1 ELISA | DRG INSTRUMENTS GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG |
| 46 | 04048474035780 | EIA-3578 | EIA-3578 | Anti-RNP/Sm ELISA is a test system for the quantitative measurement of IgG class Anti-RNP/Sm ELISA is a test system for the quantitative measurement of IgG class autoantibodies against RNP/Sm in human serum or plasma. | Anti-RNP/Sm ELISA | DRG INSTRUMENTS GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG |
| 47 | 04048474035773 | EIA-3577 | EIA-3577 | Anti-Sm ELISA is a test system for the quantitative measurement of IgG class aut Anti-Sm ELISA is a test system for the quantitative measurement of IgG class autoantibodies against Sm in human serum or plasma. | Anti-Sm ELISA | DRG INSTRUMENTS GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG |
| 48 | 04048474035766 | EIA-3576 | EIA-3576 | Anti-SS-B ELISA is a test system for the quantitative measurement of IgG class a Anti-SS-B ELISA is a test system for the quantitative measurement of IgG class autoantibodies against SS-B (La) in human serum or plasma. | Anti-SS-B ELISA | DRG INSTRUMENTS GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG |
| 49 | 04048474035735 | EIA-3573 | EIA-3573 | Anti-SS-A (Ro) ELISA is a test system for the quantitative measurement of IgG cl Anti-SS-A (Ro) ELISA is a test system for the quantitative measurement of IgG class autoantibodies against SS-A (52 kDa and 60 kDa) in human serum or plasma. | Anti-SS-A (Ro) ELISA | DRG INSTRUMENTS GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG |
| 50 | 04048474035636 | EIA-3563 | EIA-3563 | ANA Combi ELISA is a test system for the qualitative measurement of ANA autoanti ANA Combi ELISA is a test system for the qualitative measurement of ANA autoantibodies directed against RNP-70, RNP/Sm, Sm, SS-A (52 and 60 kDa), SS-B, Scl-70, Centromere B and Jo-1 in human serum or plasma. | ANA Combi (ANA-8-Profile) ELISA | DRG INSTRUMENTS GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG |