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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 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 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 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 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 G B-Amyloid 1-40 Immunoreaction Cartridges - 04987270231753

No Description
FUJIREBIO INC.
231753
In Commercial Distribution

  • 04987270231753 ()

  • Number of tests per kit: 42


  • Amyloid B component IVD, kit, chemiluminescent immunoassay

Lumipulse G Specimen Diluent 1 - 04987270231203

No Description
FUJIREBIO INC.
231203
In Commercial Distribution

  • 04987270231203 ()

  • Total Volume: 1200 Milliliter


  • Buffered sample diluent 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 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

PRG Barrier Coat - E23517950

PRG BARRIER COAT
SHOFU DENTAL CORPORATION
1795
In Commercial Distribution

  • E23517950 ()
1795

  • Dental coating, tooth-desensitizing, professional

PRG Barrier Coat - E23517860

PRG BARRIER COAT MINI KIT
SHOFU DENTAL CORPORATION
1786
In Commercial Distribution

  • E23517860 ()
1786

  • Dental coating, tooth-desensitizing, professional
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