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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 BHCG Calibrators - 04987270231111

No Description
FUJIREBIO INC.
231111
In Commercial Distribution

  • 04987270231111 ()

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


  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, calibrator

Lumipulse G Specimen Diluent 2 - 04987270230985

No Description
FUJIREBIO INC.
230985
In Commercial Distribution

  • 04987270230985 ()

  • Total Volume: 20 Milliliter


  • Buffered sample diluent IVD

Lumipulse G Prolactin Calibrators - 04987270230954

No Description
FUJIREBIO INC.
230954
Not in Commercial Distribution

  • 04987270230954 ()

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


  • Prolactin IVD, calibrator

Lumipulse G FSH-N Calibrators - 04987270230930

No Description
FUJIREBIO INC.
230930
Not in Commercial Distribution

  • 04987270230930 ()

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


  • Follicle stimulating hormone (FSH) IVD, calibrator

Lumipulse G LH Calibrators - 04987270230916

No Description
FUJIREBIO INC.
230916
Not in Commercial Distribution

  • 04987270230916 ()

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


  • Luteinizing hormone (LH) IVD, calibrator

Lumipulse G Progesterone-N Calibrators - 04987270230893

No Description
FUJIREBIO INC.
230893
Not in Commercial Distribution

  • 04987270230893 ()

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


  • Progesterone IVD, calibrator

Lumipulse G Specimen Diluent 3 - 04987270230879

No Description
FUJIREBIO INC.
230879
In Commercial Distribution

  • 04987270230879 ()

  • Total Volume: 20 Milliliter


  • Buffered sample diluent IVD

Lumipulse G Testosterone Calibrators - 04987270230862

No Description
FUJIREBIO INC.
230862
In Commercial Distribution

  • 04987270230862 ()

  • Size Type = Units per kit; Units = 6; Unit of Measure = 9.0mLs


  • Total testosterone IVD, calibrator

Lumipulse G CA125II Calibrators - 04987270230688

No Description
FUJIREBIO INC.
230688
In Commercial Distribution

  • 04987270230688 ()

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


  • Cancer antigen 125 (CA125) IVD, calibrator

Lumipulse G SARS-CoV-2 Ag Immunoreaction Cartridges - 04987270260340

No Description
FUJIREBIO INC.
260340
In Commercial Distribution

  • 04987270260340 ()

  • Number of tests per kit: 42


  • SARS-CoV-2 antigen IVD, kit, chemiluminescent immunoassay
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