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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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Automated Hematology Analyzer XN-L series XN-350
SYSMEX CORPORATION
AW618382
In Commercial Distribution

  • 04987562434534 ()


  • Haematological cell analyser IVD
Automated Hematology Analyzer XN-L series XN-330
SYSMEX CORPORATION
CX851950
In Commercial Distribution

  • 04987562434527 ()


  • Haematological cell analyser IVD
UF-Fluorocell CR is used to mark white blood cells, epithelial cells and bacteria, etc. in urine or in body fluids for determination of their counts with Sysmex fully automated urine particle analyzers. UF-Fluorocell CR is intended for use only in conjunction with Sysmex diluent UF-CELLPACK CR.
SYSMEX CORPORATION
AG792864
In Commercial Distribution

  • 84987562433960 ()
  • 04987562433964 ()

  • Total Volume: 29 Milliliter


  • Buffered sample diluent IVD
UF-Fluorocell SF is used to mark formed elements in urine or in body fluids for determination of red blood cells, casts, etc. counts with the Sysmex fully automated urine particle analyzers. UF-Fluorocell SF is intended for use only in conjunction with Sysmex diluent UF-CELLPACK SF.
SYSMEX CORPORATION
CE919553
In Commercial Distribution

  • 84987562433953 ()
  • 04987562433957 ()

  • Total Volume: 29 Milliliter


  • Buffered sample diluent IVD
UF-CELLPACK CR is a diluent for Sysmex Fully Automated Urine Particle Analyzers and is intended for use only in conjunction with UF-Fluorocell CR. UF-CELLPACK CR is used to mark formed elements in urine (or in body fluid (cerebrospinal fluid, etc.)) for determination of nucleated specimens (white blood cells, epithelial cells and bacteria, etc.).
SYSMEX CORPORATION
CB505392
In Commercial Distribution

  • 84987562433946 ()
  • 04987562433940 ()

  • Total Volume: 2.1 Liter


  • Buffered sample diluent IVD
UF-CELLPACK SF is a diluent for Sysmex Fully Automated Urine Particle Analyzers and is intended for use only in conjunction with UF-Fluorocell SF. UF-CELLPACK SF is used to mark formed elements in urine (or in body fluid (cerebrospinal fluid, etc.)) for determination of non-nucleated specimens (red blood cells, casts, etc.).
SYSMEX CORPORATION
CE604532
In Commercial Distribution

  • 84987562433939 ()
  • 04987562433933 ()

  • Total Volume: 2.1 Liter


  • Buffered sample diluent IVD
UF-CELLSHEATH is a sheath fluid for Sysmex Fully Automated Urine Particle Analyzers. This reagent is used in combination with other reagents to obtain a count of the target substance by means of the flow cytometry method. UF-CELLSHEATH is used as a system fluid for sample aspiration and as a washing fluid with Sysmex Fully Automated Urine Particle Digital Imaging Devices.
SYSMEX CORPORATION
BY074501
In Commercial Distribution

  • 04987562433926 ()

  • Total Volume: 20 Liter


  • Buffered sample diluent IVD
CS-2500 COMPLETE
SYSMEX CORPORATION
BV981798
In Commercial Distribution

  • 04987562433735 ()


  • Coagulation analyser IVD, laboratory
UF-CALIBRATOR
SYSMEX CORPORATION
CN383000
In Commercial Distribution

  • 04987562433698 ()
  • 84987562433694 ()

  • Total Volume: 30 Milliliter


  • Urine sediment IVD, calibrator
UF-CONTROL contains control particles for use in quality control measurement procedure of the Sysmex Fully Automated Urine Particle Analyzers and the Sysmex Fully Automated Urine Particle Digital Imaging Device.
SYSMEX CORPORATION
BE740265
In Commercial Distribution

  • 04987562433681 ()

  • Total Volume: 30 Milliliter


  • Buffered sample diluent IVD
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