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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 FSH-N Immunoreaction Cartridges - 04987270235218

No Description
FUJIREBIO INC.
235218
Not in Commercial Distribution

  • 04987270235218 ()

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


  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay

Lumipulse G Prolactin Immunoreaction Cartridges - 04987270235195

No Description
FUJIREBIO INC.
235195
Not in Commercial Distribution

  • 04987270235195 ()

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


  • Prolactin IVD, kit, chemiluminescent immunoassay

Lumipulse G E2-III Immunoreaction Cartridges - 04987270235171

No Description
FUJIREBIO INC.
235171
In Commercial Distribution

  • 04987270235171 ()

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


  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay

Lumipulse G Mesothelin Immunoreaction Cartridges - 04987270235157

No Description
FUJIREBIO INC.
235157
In Commercial Distribution

  • 04987270235157 ()

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


  • Soluble mesothelin-related peptide (SMRP) IVD, kit, chemiluminescent immunoassay

Lumipulse G CA 19-9-N Immunoreaction Cartridges - 04987270235126

No Description
FUJIREBIO INC.
235126
Not in Commercial Distribution

  • 04987270235126 ()

  • Size Type = Tests per kit; Size Unit = 42; Unit of Measure = Tests


  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

Lumipulse G CA 15-3 Immunoreaction Cartridges - 04987270235102

No Description
FUJIREBIO INC.
235102
In Commercial Distribution

  • 04987270235102 ()

  • Size Test =Tests per kit; Size Unit = 42; Unit of Measure = Tests


  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay

Lumipulse G 25-OH Vitamin D Immunoreaction Cartridges - 04987270235089

No Description
FUJIREBIO INC.
235089
Not in Commercial Distribution

  • 04987270235089 ()

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


  • Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA)

Lumipulse G BRAHMS PCT Immunoreaction Cartridges - 04987270235058

No Description
FUJIREBIO INC.
235058
In Commercial Distribution

  • 04987270235058 ()

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


  • Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay

Lumipulse G TP-N Immunoreaction Cartridges Set - 04987270235041

No Description
FUJIREBIO INC.
235041
In Commercial Distribution

  • 04987270235041 ()

  • Size Type = Units per kit; Units = 2; Unit of Measure = 2mL
  • Size Type =Tests Per Kit; Size Unit = 42; Unit of Measure = Tests


  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay

Lumipulse BRAHMS PCT Controls - 04987270234945

No Description
FUJIREBIO INC.
234945
In Commercial Distribution

  • 04987270234945 ()

  • Size Type =Units per Kit; Units = 14; Unit of Measure = 20mLs


  • Procalcitonin (PCT) IVD, control

Lumipulse G BRAHMS PCT Calibrator Set - 04987270234938

No Description
FUJIREBIO INC.
234938
In Commercial Distribution

  • 04987270234938 ()

  • Size Type = Units per Kit; Units = 5; Unit of Measure = 10mLs


  • Procalcitonin (PCT) IVD, calibrator

Lumipulse B-Amyloid Controls - 04987270234907

No Description
FUJIREBIO INC.
234907
In Commercial Distribution

  • 04987270234907 ()

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


  • Amyloid B component IVD, control

Lumipulse G B-Amyloid 1-40 Calibrator Set - 04987270234891

No Description
FUJIREBIO INC.
234891
In Commercial Distribution

  • 04987270234891 ()

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


  • Amyloid B component IVD, calibrator

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
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