Address:MIKROFORUM RING 2,WENDELSHEIM Rhineland-Palatinate,DE
Device Description : AESKULISA PR3 sensitive is a solid phase enzyme immunoassay employing highly pur AESKULISA PR3 sensitive is a solid phase enzyme immunoassay employing highly purified native human proteinase 3 (PR3) from human neutrophil granulocytes for the quantitative and qualitative detection of antibodies against proteinase 3 in human serum. Anti-PR3 antibodies recognize specificially conformational epitopes only accessible on native PR3. The assay is an aid in the differential diagnosis of autoimmune vasculitis
Device Class : 2
Duns Number: 341714388
Premarket Exempt : No
Prescription Use : No
Device Description : AESKULISA MPO is a solid phase enzyme immunoassay employing highly purified nati AESKULISA MPO is a solid phase enzyme immunoassay employing highly purified native myeloperoxidase (MPO) from human peripheral blood polymorphnuclear cells for the quantitative and qualitative detection of antibodies against MPO in human serum. Anti-MPO antibodies recognize specific conformational epitopes only accessible on native MPO. The assay is a tool in the differential diagnosis of autoimmune systemic vasculitis.
Device Class : 2
Duns Number: 341714388
Premarket Exempt : No
Prescription Use : No
Device Description : AESKULISA Glia-A is a solid phase enzyme immunoassay employing highly purified a AESKULISA Glia-A is a solid phase enzyme immunoassay employing highly purified alphaGliadin for the quantitative and qualitative detection of IgA antibodies against gliadin in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy).
Device Class : 2
Duns Number: 341714388
Premarket Exempt : No
Prescription Use : No
Device Description : AESKULISA Glia-G is a solid phase enzyme immunoassay employing highly purified a AESKULISA Glia-G is a solid phase enzyme immunoassay employing highly purified alphaGliadin for the quantitative and qualitative detection of IgG antibodies against Gliadin in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy).
Device Class : 2
Duns Number: 341714388
Premarket Exempt : No
Prescription Use : No
Device Description : AESKULISA ASCA-A is a solid phase enzyme immunoassay (ELISA) employing highly pu AESKULISA ASCA-A is a solid phase enzyme immunoassay (ELISA) employing highly purified mannan for the quantitative and qualitative detection of IgA anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specifically mannan, a component of the outer cell wall of yeast. The assay is highly specific and sensitive for Crohn`s disease.
Device Class : 2
Duns Number: 341714388
Premarket Exempt : No
Prescription Use : No
Device Description : AESKULISA ASCA-G is a solid phase enzyme immunoassay (ELISA) employing highly pu AESKULISA ASCA-G is a solid phase enzyme immunoassay (ELISA) employing highly purified mannan for the quantitative and qualitative detection of IgG anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specific mannan, a component of the outer cell wall of yeast. The assay is highly specific and sensitive for Crohn`s disease.
Device Class : 2
Duns Number: 341714388
Premarket Exempt : No
Prescription Use : No
Device Description : AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 gly AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 glycoprotein I highly purified from human plasma for the quantitative and qualitative detection of IgA antibodies against β2 glycoprotein I in human serum. Anti-β2 glycoprotein I antibodies recognize specific epitopes on human β2 glycoprotein I which are expressed only when β2 glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome. 30'+30'+30' automation incubation.
Device Class : 2
Duns Number: 341714388
Premarket Exempt : No
Prescription Use : No
Device Description : AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2gly AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the separate quantitative and qualitative detection of IgG and / or IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS).30'+30'+30' automation incubation.
Device Class : 2
Duns Number: 341714388
Premarket Exempt : No
Prescription Use : No
Device Description : AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2 AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS).30'+30'+30' automation incubation.
Device Class : 2
Duns Number: 341714388
Premarket Exempt : No
Prescription Use : No
Device Description : AESKULISA Glia-A is a solid phase enzyme immunoassay employing highly purified a AESKULISA Glia-A is a solid phase enzyme immunoassay employing highly purified alphaGliadin for the quantitative and qualitative detection of IgA antibodies against gliadin in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy). 30'+30'+30' automation incubation.
Device Class : 2
Duns Number: 341714388
Premarket Exempt : No
Prescription Use : No