AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin
Aesku.Diagnostics GmbH & Co. KG
AESKU.INC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004139006 | 3004139006 | AESKU.INC | 1 | Y | 2026-01-01 | 455 State Street Suite 100 Des Plaines IL US 60016 |
| 3007510296 | 3007510296 | AESKU.SYSTEMS GMBH&CO.KG. | 1 | N | 2020-04-25 | AESKU.SYSTEMS GmbH&Co.KG. Mikroforum Ring 3 Wendelsheim Rheinland-Pfalz DE 55234 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 171939 | 1304677826 | K153117 | AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM | DHN | 2016-07-28 |
| 171939 | 1327589884 | ||||
| 171939 | 1956223600 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DHN | 1 | 2016-07-28 |
PMN#
AESKUSLIDES NDNA (Crithidia Luciliae), AESKUSLIDES NDNA (Crithidia Luciliae) Demo Kit, AESKUSLIDES NDNA (Crithidia Luciliae) Bulk Kit X5, AESKUSLIDES NDNA (Crithidia Luciliae) Bulk Kit X10
Aesku Diagnostics GmbH & Co. KG
AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM
AESKU. SYSTEMS GMBH & CO. KG
AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK
AESKU.DIAGNOSTICS
AESKUSLIDES ANA HEP-2
AESKU DIAGNOSTICS
AESKU PR3
AESKU.DIAGNOSTICS
AESKULISA MPO, MODEL 30-7303US
AESKU.DIAGNOSTICS
MODIFICATION TO AESKULISA DS DNA G
AESKU.DIAGNOSTICS
AESKULISA ANA HEP-2, REF 30-7115US
AESKU.DIAGNOSTICS
AESKULSKA BETA2-GLYCO-A
AESKU, INC
AESKULISA GLIA A AND AESKULISA GLIA G
AESKU.DIAGNOSTICS
AESKULISA ASCA A
AESKU.INC
AESKULISA TTG A AND AESKULISA TTG G
AESKU, INC
AESKULISA DS DNA G
AESKU.DIAGNOSTICS
AESKULISA ENA 6 S
AESKU.DIAGNOSTICS
AESKULISA ANA HEP-2
AESKU, INC
AESKULISA CARDIOLIPIN AGM
AESKU, INC
AESKULISA ANA 8PRO
AESKU, INC
GUDID#
HERA - REF.HER-1000
2023-07-20
AESKULISA® ANA HEp-2 - 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 and specific antigens. 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, Jo-1 and centromeric antigens along with sera positive for HEp2 immunofluorescence test (IFT). The assay is a tool in the diagnosis of certain systemic rheumatic diseases and should be used in conjunction with other serological tests and clinical findings.
2017-02-28
AESKULISA® dsDNA G - 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. The assay is a tool in the diagnosis of systemic lupus erythematosus (SLE) and should be used in conjunction with other serological tests and clinical findings.
2017-02-28
AESKUSLIDES® ANA-HEp-2 gamma - AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum.
2017-02-28
AESKUSLIDES® ANA-HEp-2 - AESKUSLIDES ANA HEp-2 is an indirect fluorescent antibody assay utilizing HEp-2 tissue culture cells as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum. AESKUSLIDES ANA HEp-2 Test System is intended for use as aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings.
2017-02-28
AESKULISA® ANA-HEp-2 - 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.
2017-03-02
AESKULISA® ENA-6Pro - 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.
2017-02-28
AESKULISA® ENA-6S - 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.
2017-02-28
AESKULISA® ANA-8Pro - 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.
2017-02-28
AESKULISA® ANA-HEp-2 - 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.
2016-09-27
AESKULISA® ENA-6Pro - 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.
2016-09-27
AESKULISA® ENA-6S - 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.
2016-09-27
AESKULISA® ANA-8Pro - 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.
2016-09-27
AESKUSLIDES® ANA-HEp-2 - AESKUSLIDES ANA-HEp-2 is an indirect immunofluorescence assay to detect nuclear and / or cytoplasmic autoantibodies in human serum. The assay is a tool in the differential diagnosis of systemic rheumatic diseases like systemic lupus erythematosus (SLE), mixed connective tissue diseases (MCTD), scleroderma, Sjögren’s syndrome (SS), polymyositis and dermatomyositis.
2016-09-27
AESKUSLIDES® ANA-HEp-2 gamma - AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum.
2025-04-06
AESKUSLIDES® ANA-HEp-2 gamma - AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum.
2025-04-06
AESKUSLIDES® ANA HEp-2-Gamma - AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum by manual microscopy or with the HELIOS® Automated IFA System.This in vitro diagnostic assay is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings.
2025-05-27
AESKUSLIDES nDNA (Crithidia luciliae) - AESKUSLIDES® nDNA (Crithidia luciliae) is an indirect immunofluorescence assay utilizing Crithidia luciliae coated slides as a substrate for the qualitative and/or semi-quantitative determination of antibodies to native double stranded DNA (dsDNA) in human serum. This in vitro diagnostic assay is used as an aid for the diagnosis of Systemic Lupus Erythematosus (SLE) in conjunction with other clinical and laboratory findings. The assay can be processed manually and analyzed at the microscope or processed and analyzed with HELIOS® Automated IFA System. All suggested results obtained with the HELIOS® Automated IFA System must be confirmed by trained personnel.
2018-05-14
AESKUSLIDES ANCA Formalin - AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM.This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings.All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel.
2018-05-25
HELIOS® Automated IFA System - REF.IOS-1000.US
2025-01-03
HELMED® Automated IFA Processor - REF.HEL-1000.US
2025-01-03
HELMED® AUTOMATED IFA PROCESSOR - REF.HEL-1000
2023-06-25
HELIOS® AUTOMATED IFA SYSTEM - REF.IOS-1000
2023-06-25
AESKUSLIDES® nDNA (Crithidia luciliae) - AESKUSLIDES® nDNA (Crithidia luciliae) is an indirect immunofluorescence assay utilizing Crithidia luciliae coated slides as a substrate for the qualitative and/or semi-quantitative determination of antibodies to native double stranded DNA (dsDNA) in human serum.
2024-11-15
AESKUSLIDES ANCA Ethanol - AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM.This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings.All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel.
2018-05-25
AESKUSLIDES ANCA Formalin - AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM.This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings.All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel.
2018-05-25
AESKUSLIDES ANCA Ethanol - AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM.This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings.All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel.
2018-05-25
AESKULISA® DGP-Check - AESKULISA DGP-Check is an in-vitro diagnostic device. This solid phase enzyme immunoassay employs synthetic, deamidated gliadin-derived peptides for the combined semiquantitative and qualitative detection of IgA and IgG antibodies against deamidated Gliadin-specific peptides (DGP) in human serum.30'+30'+30' automation incubation.
2017-03-01
AESKULISA® DGP-G - AESKULISA DGP-G is a solid phase enzyme immunoassay employing synthetic, deamidated gliadin-derived peptides for the quantitative and qualitative detection of IgG antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy). 30'+30'+30' automation incubation.
2017-02-28
AESKULISA® DGP-A - AESKULISA DGP-A is a solid phase enzyme immunoassay employing synthetic, deamidated gliadin-derived peptides for the quantitative and qualitative detection of IgA antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy). 30'+30'+30' automation incubation.
2017-02-28
AESKULISA® DGP-Check - AESKULISA DGP-Check is a solid phase enzyme immunoassay employing synthetic, deamidated gliadin-derived peptides for the combined quantitative and qualitative detection of IgA and IgG antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy).
2016-09-27
AESKULISA® DGP-G - AESKULISA DGP-G is a solid phase enzyme immunoassay employing synthetic, deamidated gliadin-derived peptides for the quantitative and qualitative detection of IgG antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy).
2016-09-27
AESKULISA® DGP-A - AESKULISA DGP-A is a solid phase enzyme immunoassay employing synthetic, deamidated gliadin-derived peptides for the quantitative and qualitative detection of IgA antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy).
2016-09-27
AESKULISA® MPO - 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. 30'+30'+30' automation incubation.
2017-02-28
AESKULISA® PR3 sensitive - 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.30'+30'+30' automation incubation.
2017-02-28
AESKULISA® ASCA-G - 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.
2017-03-17
AESKULISA® ASCA-A - 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.
2017-03-17
AESKULISA tTg-G New Generation - 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.
2017-03-17
AESKULISA tTg-A New Generation - 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.
2017-03-17
AESKULISA® Glia-G - 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).
2017-03-17