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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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For use in obturating root canals as part of orthograde root canal therapy with gutta percha.
NUSMILE, LTD.
ANSIK
In Commercial Distribution

  • 00850008515125 ()

  • Weight: 2.2 Gram


  • Hygroscopic dental cement
Left and right eye cups for the AdaptDx Pro headset.
MACULOGIX, INC.
10319
In Commercial Distribution

  • 10850006785046 ()
  • 00850006785049 ()


  • Adaptometer
The Alere NT-proBNP for Alinity i assay is a chemiluminescent microparticle immunoassay (CMIA) used for the in vitro quantitative determination of N-terminal pro B-type natriuretic peptide (NT-proBNP) in human serum and plasma on the Alinity i system. In the emergency department, measurements of NT-proBNP are used as an aid in the diagnosis of heart failure (HF) in patients with clinical suspicion of new onset or worsening HF.
AXIS-SHIELD DIAGNOSTICS LIMITED
04S7921
In Commercial Distribution

  • 05055845400596 ()
04S7921

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay
The Axis-Shield Anti-CCP test is a semi-quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum (including Serum Separator Tubes) or plasma (EDTA, lithium heparin, or sodium citrate). Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA), and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-criterion diagnostic process, encompassing both clinical and laboratory-based assessments
AXIS-SHIELD DIAGNOSTICS LIMITED
FCCP600
In Commercial Distribution

  • 05055845400497 ()
FCCP600

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, enzyme immunoassay (EIA)
The Axis-Shield Anti-CCP test is a semi-quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum (including Serum Separator Tubes) or plasma (EDTA, lithium heparin, or sodium citrate). Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA), and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-criterion diagnostic process, encompassing both clinical and laboratory-based assessments.
AXIS-SHIELD DIAGNOSTICS LIMITED
FCCP600
Not in Commercial Distribution

  • 05055845400008 ()
FCCP600

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, enzyme immunoassay (EIA)
No Description
ELLIQUENCE, LLC
N6-D4/1
In Commercial Distribution

  • 00846338001513 ()


  • Endoscopic-access dilator, single-use
The SCIMEDX immunofluorescence assay (IFA) is for the in vitro diagnostic detection of anti-neutrophil cytoplasmic antibodies in human serum using ethanol-fixed human neutrophils as substrate. The test is intended as an aid in the diagnosis of Granulomatosis with Polyangiitis (GPA), idiopathic crescentic glomerulonephritis, microscopic polyarteritis, and pulmonary renal syndrome.
ZEUS SCIENTIFIC, INC.
A060L
In Commercial Distribution

  • 00845533001984 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
The Anti-Neutrophil Cytoplasmic Antibodies (Formalin-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 dIFine®. 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 dIFine® must be confirmed by a trained operator.
ZEUS SCIENTIFIC, INC.
FA9611-0510
In Commercial Distribution

  • 00845533001977 ()
FA9611-0510

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
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 dIFine®. 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 dIFine® 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
The ASA (Monkey Esophagus) kit is designed for the qualitative and semi-quantitative detection of antibodies associated with Pemphigus and Bullous Pemphigoid by the indirect fluorescent antibody (IFA) technique and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
FA6001
In Commercial Distribution

  • 00845533001946 ()
FA6001

  • Skin antibody IVD, kit, fluorescent immunoassay
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