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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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.
Aesku.Diagnostics GmbH & Co. KG
54.100.US
In Commercial Distribution

  • 04250289510356 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
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.
Aesku.Diagnostics GmbH & Co. KG
51.101.US.Bulk5
In Commercial Distribution

  • 04250289504942 ()
51.101.US.Bulk5

  • Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay
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.
Aesku.Diagnostics GmbH & Co. KG
51.100.US
In Commercial Distribution

  • 04250289504461 ()
51.100.US

  • Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay
No Description
BIOGENEX LABORATORIES
AR125-5R
In Commercial Distribution

  • 00810119672964 ()

  • Total Volume: 6 Milliliter
AR125-5R

  • Toxoplasma gondii total antibody IVD, control
No Description
BIOGENEX LABORATORIES
AN449-5M
In Commercial Distribution

  • 00810119672957 ()

  • Total Volume: 6 Milliliter
AN449-5M

  • p504s protein IVD, antibody
No Description
BIOGENEX LABORATORIES
AM054-5M
In Commercial Distribution

  • 00810119672933 ()

  • Total Volume: 6 Milliliter
AM054-5M

  • Tumour-associated glycoprotein-72 (TAG72) IVD, antibody
No Description
BIOGENEX LABORATORIES
AM947-5M
In Commercial Distribution

  • 00810119672919 ()

  • Total Volume: 6 Milliliter
AM947-5M

  • CD20 cell marker IVD, antibody
No Description
BIOGENEX LABORATORIES
AM109-5M
In Commercial Distribution

  • 00810119672896 ()

  • Total Volume: 6 Milliliter
AM109-5M

  • Smooth muscle myosin IVD, antibody
No Description
BIOGENEX LABORATORIES
AM534-5M
In Commercial Distribution

  • 00810119672889 ()

  • Total Volume: 6 Milliliter
AM534-5M

  • Mucin IVD, antibody
No Description
BIOGENEX LABORATORIES
AMA77-5M
In Commercial Distribution

  • 00810119672438 ()

  • Total Volume: 6 Milliliter
AMA77-5M

  • Desmoglein 3 (DSG3) IVD, antibody
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