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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 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 CA 19-9-N Calibrators - 04987270230664

No Description
FUJIREBIO INC.
230664
Not in Commercial Distribution

  • 04987270230664 ()

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


  • Cancer antigen 19-9 (CA19-9) IVD, calibrator

Lumipulse G CA 15-3 Calibrators - 04987270230640

No Description
FUJIREBIO INC.
230640
In Commercial Distribution

  • 04987270230640 ()

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


  • Cancer antigen 15-3 (CA15-3) IVD, calibrator

Lumipulse PTH Controls - 04987270230213

No Description
FUJIREBIO INC.
230213
Not in Commercial Distribution

  • 04987270230213 ()

  • Size Type = Units per Kit; Units = 4; Unit of Measure = 12mLs


  • Parathyroid hormone (PTH) IVD, control

Lumipulse G Whole PTH Calibrators - 04987270230206

No Description
FUJIREBIO INC.
230206
Not in Commercial Distribution

  • 04987270230206 ()

  • Size Type =Units per Kit; Units = 2; Unit of Measure = 4.5mLs


  • Parathyroid hormone (PTH) IVD, calibrator

Lumipulse G whole PTH Immunoreaction Cartridges - 04987270230190

No Description
FUJIREBIO INC.
230190
Not in Commercial Distribution

  • 04987270230190 ()

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


  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay

Lumipulse G Wash Solution - 00850212007096

Lumipulse G Wash Solution
FUJIREBIO DIAGNOSTICS, INC.
4008248
In Commercial Distribution

  • 00850212007096 ()

  • Size Type = Units Per Kit; Units = 1; Unit of Measure = 1000mLs


  • Buffered wash solution IVD

PRG Barrier Coat - E235Y29100

PRG BARRIER COAT SET BOTTLE TYPE
SHOFU DENTAL CORPORATION
Y2910
In Commercial Distribution

  • E235Y29100 ()
Y2910

  • Dental coating, tooth-desensitizing, professional

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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