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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The Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed) test system is an indirect immunofluorescence assay (IFA) for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of the IgG isotype in human serum by manual fluorescence microscopy or with dIFineĀ®. The presence of ANCA in conjunction with other clinical and laboratory findings can be used to aid in the diagnosis of ANCA associated vasculitis (AAV). All suggested results obtained with dIFineĀ® must be confirmed by a trained operator.
ZEUS SCIENTIFIC, INC.
FA9601-1010
In Commercial Distribution

  • 00845533001960 ()
FA9601-1010

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
Anti-MPO is an ELISA test system for the quantitative measurement of IgG class autoantibodies against myeloperoxidase (MPO) in human serum or plasma. This product is intended for professional in vitro diagnostic use only.
ORGENTEC Diagnostika GmbH
ORG519
Not in Commercial Distribution

  • 04260157080188 ()
ORG519

  • Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, multiplex
Anti-PR3 is an ELISA test system for the quantitative measurement of IgG class autoantibodies against proteinase 3 (PR3) in human serum or plasma. This product is intended for professional in vitro diagnostic use only.
ORGENTEC Diagnostika GmbH
ORG518
Not in Commercial Distribution

  • 04260157080171 ()
ORG518

  • Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, multiplex
Anti-Cardiolipin Screen is an ELISA test system for the quantitative measurement of IgG, IgM and IgA class autoantibodies against cardiolipin in human serum or plasma. This product is intended for professional in vitro diagnostic use only.
ORGENTEC Diagnostika GmbH
ORG515S
Not in Commercial Distribution

  • 04260157080140 ()
ORG515S

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
Anti-Cardiolipin Screen is an ELISA test system for the quantitative measurement of IgA class autoantibodies against cardiolipin in human serum or plasma. This product is intended for professional in vitro diagnostic use only.
ORGENTEC Diagnostika GmbH
ORG515A
Not in Commercial Distribution

  • 04260157080133 ()
ORG515A

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
Anti-Cardiolipin IgG/IgM is an ELISA test system for the quantitative measurement of IgG and IgM class autoantibodies against cardiolipin in human serum or plasma. This product is intended for professional in vitro diagnostic use only.
ORGENTEC Diagnostika GmbH
ORG515
Not in Commercial Distribution

  • 04260157080126 ()
ORG515

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
Amato Probes Set 16.5cm 6-20mm set of 10 (without case)
Geister Medizintechnik GmbH
21-8250
In Commercial Distribution

  • 04057034052129 ()
21-8250

  • Vascular dilator, reusable
No Description
Siemens Healthcare GmbH
11665780
In Commercial Distribution

  • 04056869996172 ()


  • CT system application software
No Description
Siemens Healthcare GmbH
11665409
Not in Commercial Distribution

  • 04056869964331 ()


  • CT system application software
No Description
Siemens Healthcare GmbH
11583325
In Commercial Distribution

  • 04056869297293 ()


  • CT system application software
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