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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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The Axis-Shield Homocysteine Control Kit is intended to be used as an assayed quality control serum when used for the quantitative measurement of total L-homocysteine in human serum or plasma.
AXIS-SHIELD DIAGNOSTICS LIMITED
FHCY200
In Commercial Distribution

  • 05055845400022 ()
FHCY200

  • Homocysteine IVD, control
The Axis® Homocysteine Enzyme Immunoassay (EIA) is intended for the quantitative determination of total L-homocysteine in human serum or plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
AXIS-SHIELD DIAGNOSTICS LIMITED
FHCY100
Not in Commercial Distribution

  • 05055845400015 ()
FHCY100

  • Homocysteine IVD, reagent
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)
MPP23092 1q41 in FITC Spectrum (ASR)
CYTOCELL LIMITED
MPP23092
In Commercial Distribution

  • 05055844934849 ()


  • Assay development analyte-specific reagent IVD
MPP23091 1q32.1 in Orange Spectrum (ASR)
CYTOCELL LIMITED
MPP23091
In Commercial Distribution

  • 05055844934832 ()


  • Assay development analyte-specific reagent IVD
MPP23083 1p36.21 in Aqua Spectrum (ASR)
CYTOCELL LIMITED
MPP23083
In Commercial Distribution

  • 05055844934825 ()


  • Assay development analyte-specific reagent IVD
MPH48242 CCND3 Distal in FITC Spectrum (ASR)
CYTOCELL LIMITED
MPH48242
In Commercial Distribution

  • 05055844934788 ()


  • Assay development analyte-specific reagent IVD
MPH48241 CCND3 Proximal in Texas Red Spectrum (ASR)
CYTOCELL LIMITED
MPH48241
In Commercial Distribution

  • 05055844934771 ()


  • Assay development analyte-specific reagent IVD
MPP16302 YAP1 Distal in FITC Spectrum (ASR)
CYTOCELL LIMITED
MPP16302
In Commercial Distribution

  • 05055844934764 ()


  • Assay development analyte-specific reagent IVD
MPP16301 YAP1 Proximal in Texas Red Spectrum (ASR)
CYTOCELL LIMITED
MPP16301
In Commercial Distribution

  • 05055844934757 ()


  • Assay development analyte-specific reagent IVD
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