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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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Pilon Fusion, Drill Guide, Monster
Paragon 28, Inc.
P51-926-2001
In Commercial Distribution

  • 00889795146113 ()
P51-926-2001

  • Surgical drill guide, reusable
Pilon Fusion, Proximal Drill Guide
Paragon 28, Inc.
P51-926-1003
In Commercial Distribution

  • 00889795146090 ()
P51-926-1003

  • Surgical drill guide, reusable
Pilon Fusion, Trocar
Paragon 28, Inc.
P51-926-1001
In Commercial Distribution

  • 00889795146076 ()
P51-926-1001

  • Orthopaedic implantation sleeve, reusable
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.
Aesku.Diagnostics GmbH & Co. KG
51.181.US.BULK5
In Commercial Distribution

  • 04250289513562 ()
51.181.US.BULK5

  • Multiple antinuclear antibody (ANA) screening 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.
Aesku.Diagnostics GmbH & Co. KG
51.181.US
In Commercial Distribution

  • 04250289513487 ()
51.181.US

  • Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay
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
54.050.US
In Commercial Distribution

  • 04250289510370 ()


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

  • 04250289513401 ()
53.120.US

  • Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay
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.
Aesku.Diagnostics GmbH & Co. KG
53.100.US
In Commercial Distribution

  • 04250289510394 ()


  • Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay
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