Address:MIKROFORUM RING 2,WENDELSHEIM Rhineland-Palatinate,DE
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). 30'-30'-30' incubation time
Device Class : 2
Duns Number: 341714388
Premarket Exempt : No
Prescription Use : No
Device Description : The AESKULISA tTg-A New generation is a solid phase enzyme immunoassay for the q The AESKULISA tTg-A New generation is a solid phase enzyme immunoassay for the quantitative and qualitative detection of IgA antibodies against neo-epitopes of tissue transglutaminase (tTG) in human serum. 30'+30'+30' automation incubation.
Device Class : 2
Duns Number: 341714388
Premarket Exempt : No
Prescription Use : No
Device Description : The AESKULISA tTg-G New Generation is a solid phase enzyme immunoassay for the q The AESKULISA tTg-G New Generation is a solid phase enzyme immunoassay for the quantitative and qualitative detection of IgG antibodies against neo-epitopes of tissue transglutaminase (tTG) in human serum.30'+30'+30' automation incubation.
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. 30'+30'+30' automation incubation.
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. 30'+30'+30' automation incubation.
Device Class : 2
Duns Number: 341714388
Premarket Exempt : No
Prescription Use : No
Device Description : 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.
Device Class : 2
Duns Number: 341714388
Premarket Exempt : No
Prescription Use : No
Device Description : AESKULISA ENA-6S is a solid phase enzyme immunoassay for the combined qualitativ AESKULISA ENA-6S is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. Each well is 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.
Device Class : 2
Duns Number: 341714388
Premarket Exempt : No
Prescription Use : No
Device Description : 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.
Device Class : 2
Duns Number: 341714388
Premarket Exempt : No
Prescription Use : No
Device Description : 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).
Device Class : 2
Duns Number: 341714388
Premarket Exempt : No
Prescription Use : No
Device Description : 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)
Device Class : 2
Duns Number: 341714388
Premarket Exempt : No
Prescription Use : No