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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 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 G Substrate Solution - 04987270231197

No Description
FUJIREBIO INC.
231197
In Commercial Distribution

  • 04987270231197 ()

  • Total Volume: 600 Milliliter


  • Chemiluminescent substrate reagent IVD

Lumipulse G Wash Solution - 04987270231173

No Description
FUJIREBIO INC.
231173
In Commercial Distribution

  • 04987270231173 ()

  • Total Volume: 1000 Milliliter


  • Buffered wash solution IVD

Lumipulse G TSH-III Calibrators - 04987270231135

No Description
FUJIREBIO INC.
231135
Not in Commercial Distribution

  • 04987270231135 ()

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


  • Thyroid stimulating hormone (TSH) IVD, calibrator

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 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 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
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