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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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Lumipulse G B-Amyloid 1-42 Calibrator Set - 04987270234884

No Description
FUJIREBIO INC.
234884
In Commercial Distribution

  • 04987270234884 ()

  • Number of Bottles per kit: 7
  • Total mLs per bottle: 10


  • Amyloid B component IVD, calibrator

Lumipulse G Specimen Diluent 6 - 04987270234693

No Description
FUJIREBIO INC.
234693
In Commercial Distribution

  • 04987270234693 ()

  • Total Volume: 20 Milliliter


  • Buffered sample diluent IVD

Lumipulse G CA125II Immunoreaction Cartridges - 04987270234273

No Description
FUJIREBIO INC.
234273
In Commercial Distribution

  • 04987270234273 ()

  • Size Type = Tests Per Kit; Size Unit = 42; Unit of Measure = Tests


  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

Lumipulse G HE4 Calibrators - 04987270234181

No Description
FUJIREBIO INC.
234181
Not in Commercial Distribution

  • 04987270234181 ()

  • Size Type = Units Per Kit; Units = 2; Unit of Measure = 3.0mLs


  • Human epididymis protein 4 (HE4) IVD, calibrator

Lumipulse G HE4 Immunoreaction Cartridges - 04987270234174

No Description
FUJIREBIO INC.
234174
Not in Commercial Distribution

  • 04987270234174 ()

  • Size Type = Tests Per Kit; Size Unit = 42; Unit of Measure = Tests


  • Human epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassay

Lumipulse G 25-OH Vitamin D Calibrators - 04987270234020

No Description
FUJIREBIO INC.
234020
Not in Commercial Distribution

  • 04987270234020 ()

  • Size Type = Units per Kit; Units = 6; Units of measure = 1.5mL


  • Multiple form 25-hydroxy Vitamin D IVD, calibrator

Lumipulse G E2-III Calibrators - 04987270233849

No Description
FUJIREBIO INC.
233849
In Commercial Distribution

  • 04987270233849 ()

  • Size Type = Units Per Kit; Units = 3; Unit of Measure = 4.5mLs


  • Estradiol (oestradiol) (E2) IVD, calibrator

Lumipulse G Mesothelin Calibrator - 04987270233436

No Description
FUJIREBIO INC.
233436
In Commercial Distribution

  • 04987270233436 ()

  • Size Type = Units per kit; Units = 3; Unit of Measure = 4.5mLs


  • Soluble mesothelin-related peptide (SMRP) IVD, calibrator

Lumipulse SARS-CoV-2 Ag Controls - 04987270231876

No Description
FUJIREBIO INC.
231876
In Commercial Distribution

  • 04987270231876 ()

  • Number of bottles per kit: 1
  • Total mLs per bottle: 10mL


  • SARS-CoV-2 antigen IVD, control

Lumipulse G SARS-CoV-2 Ag Calibrator Set - 04987270231869

No Description
FUJIREBIO INC.
231869
In Commercial Distribution

  • 04987270231869 ()

  • Number of bottles per kit: 1
  • Total mLs per bottle: 10mL


  • SARS-CoV-2 antigen IVD, calibrator
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