Aesku.Diagnostics GmbH & Co. KG

Address:MIKROFORUM RING 2,WENDELSHEIM Rhineland-Palatinate,DE

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- Catalog Number : 7106US

Device Description : 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).

Device Class : 2

Duns Number: 341714388

Premarket Exempt : No

Product Code : LJM

Prescription Use : No

Device Count : 1

- Catalog Number : 7107US

Device Description : 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).

Device Class : 2

Duns Number: 341714388

Premarket Exempt : No

Product Code : LJM

Prescription Use : No

Device Count : 1

- Catalog Number : 7110US

Device Description : 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).

Device Class : 2

Duns Number: 341714388

Premarket Exempt : No

Product Code : LJM

Prescription Use : No

Device Count : 1

- Catalog Number : 7111US

Device Description : 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.

Device Class : 2

Duns Number: 341714388

Premarket Exempt : No

Product Code : LJM

Prescription Use : No

Device Count : 1

- Catalog Number : 7112US

Device Description : 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.

Device Class : 2

Duns Number: 341714388

Premarket Exempt : No

Product Code : LJM

Prescription Use : No

Device Count : 1

- Catalog Number : 7113US

Device Description : 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.

Device Class : 2

Duns Number: 341714388

Premarket Exempt : No

Product Code : LJM

Prescription Use : No

Device Count : 1

Device Description : AESKULISA ANA-HEp-2 is a solid phase enzyme immunoassay for the combined qualita AESKULISA ANA-HEp-2 is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against HEp2 cells in human serum. Each well is coated with lysed HEp2 cells. The test collectively detects, in one well, total ANAs against double stranded DNA (dsDNA), histones, SS-A (Ro), SS-B (La), Sm, snRNP/Sm, Scl-70, PM-Scl, Jo-1 and centromeric antigens along with sera positive for HEp2 immunofluorescence test (IFT). The assay is a tool in the diagnosis of systemic rheumatic diseases like systemic lupus erythematosus (SLE), mixed connective tissue diseases (MCTD), scleroderma, Sjögren`s syndrome, polymyositis and dermatomyositis.

Device Class : 2

Duns Number: 341714388

Premarket Exempt : No

Product Code : DHN

Prescription Use : No

Device Count : 1

- Catalog Number : 7142US

Device Description : AESKULISA dsDNA-G is a solid phase enzyme immunoassay with human recombinant dou AESKULISA dsDNA-G is a solid phase enzyme immunoassay with human recombinant double-stranded DNA (dsDNA) for the quantitative and qualitative detection of IgG antibodies against dsDNA in human serum. Anti-dsDNA antibodies mainly recognize the phosphat units of the DNA, thus these autoantibodies also bind single stranded DNA (ssDNA). To ensure correct quantitation of anti-dsDNA antibodies the used antigen has been proven to be free of contamination with ssDNA. The assay is a tool in the differential diagnosis of systemic lupus erythematosus (SLE).

Device Class : 2

Duns Number: 341714388

Premarket Exempt : No

Product Code : LSW

Prescription Use : No

Device Count : 1

Device Description : AESKULISA Cardiolipin-Check is a solid phase enzyme immunoassay employing highly AESKULISA Cardiolipin-Check is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against cardiolipin in human serum. Anticardiolipin antibodies mainly recognize specific epitopes on a complex composed out of cardiolipin and ß2-glycoprotein I which are expressed only when ß2-glycoprotein I interacts with cardiolipin. The assay is an aid in the diagnosis and risk estimation of thrombosis in patients with systemic lupus erythematosus (SLE).

Device Class : 2

Duns Number: 341714388

Premarket Exempt : No

Product Code : MID

Prescription Use : No

Device Count : 1

Device Description : AESKULISA Cardiolipin-A is a solid phase enzyme immunoassay employing highly pur AESKULISA Cardiolipin-A is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the quantitative and qualitative detection of IgA antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed out of cardiolipin and ß2-glycoprotein I which are expressed only when ß2-glycoprotein I interacts with cardiolipin. The assay is an aid in the diagnosis and risk estimation of thrombosis in patients with systemic lupus erythematosus (SLE).

Device Class : 2

Duns Number: 341714388

Premarket Exempt : No

Product Code : MID

Prescription Use : No

Device Count : 1