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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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
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
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)
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
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
No Description
FUJIREBIO INC.
234945
In Commercial Distribution

  • 04987270234945 ()

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


  • Procalcitonin (PCT) IVD, control
No Description
FUJIREBIO INC.
234938
In Commercial Distribution

  • 04987270234938 ()

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


  • Procalcitonin (PCT) IVD, calibrator
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
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
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
No Description
FUJIREBIO INC.
234693
In Commercial Distribution

  • 04987270234693 ()

  • Total Volume: 20 Milliliter


  • Buffered sample diluent IVD
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
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
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
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
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
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
No Description
FUJIREBIO INC.
231876
In Commercial Distribution

  • 04987270231876 ()

  • Number of bottles per kit: 1
  • Total mLs per bottle: 10mL


  • SARS-CoV-2 antigen IVD, control
No Description
FUJIREBIO INC.
231869
In Commercial Distribution

  • 04987270231869 ()

  • Number of bottles per kit: 1
  • Total mLs per bottle: 10mL


  • SARS-CoV-2 antigen IVD, calibrator
No Description
FUJIREBIO INC.
231753
In Commercial Distribution

  • 04987270231753 ()

  • Number of tests per kit: 42


  • Amyloid B component IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
231432
In Commercial Distribution

  • 04987270231432 ()

  • Number of tests per kit: 42


  • Amyloid B component IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
231203
In Commercial Distribution

  • 04987270231203 ()

  • Total Volume: 1200 Milliliter


  • Buffered sample diluent IVD
No Description
FUJIREBIO INC.
231197
In Commercial Distribution

  • 04987270231197 ()

  • Total Volume: 600 Milliliter


  • Chemiluminescent substrate reagent IVD
No Description
FUJIREBIO INC.
231173
In Commercial Distribution

  • 04987270231173 ()

  • Total Volume: 1000 Milliliter


  • Buffered wash solution IVD
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
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
No Description
FUJIREBIO INC.
230985
In Commercial Distribution

  • 04987270230985 ()

  • Total Volume: 20 Milliliter


  • Buffered sample diluent IVD
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
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
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
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
No Description
FUJIREBIO INC.
230879
In Commercial Distribution

  • 04987270230879 ()

  • Total Volume: 20 Milliliter


  • Buffered sample diluent IVD
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
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
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
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
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
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
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
No Description
FUJIREBIO INC.
235584
In Commercial Distribution

  • 04987270235584 ()

  • Number of bottles per kit = 8
  • Total mLs per bottle = 3/3/2.5


  • Multiple blood-borne virus antigen/antibody IVD, control
Gelweave Gelatin Impregnated Woven Vascular Prosthesis 4 BRANCH PLEXUS
VASCUTEK LTD
73241288/10S
In Commercial Distribution

  • 05037881999968 ()

  • Length: 50 Centimeter
  • Branch diameter 12/8/8/10 mm
  • Branch length 20/20/20/25 cm
  • Lumen/Inner Diameter: 24 Millimeter
73241288/10S

  • Synthetic vascular graft
Gelweave Gelatin Impregnated Woven Vascular Prosthesis 4 BRANCH PLEXUS
VASCUTEK LTD
73261288/10S
In Commercial Distribution

  • 05037881999951 ()

  • Branch diameter 12/8/8/10 mm
  • Branch length 20/20/20/25 cm
  • Length: 50 Centimeter
  • Lumen/Inner Diameter: 26 Millimeter
73261288/10S

  • Synthetic vascular graft
Gelweave Gelatin Impregnated Woven Vascular Prosthesis ANGLED 4 BRANCH PLEXUS
VASCUTEK LTD
73241088/10SK
In Commercial Distribution

  • 05037881999906 ()

  • Branch diameter 10/8/8/10 mm
  • Branch length 30/30/30/30 cm
  • Length: 50 Centimeter
  • Lumen/Inner Diameter: 24 Millimeter
73241088/10SK

  • Synthetic vascular graft
Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis EXTRA LENGTH BIFURCATE BIFURCATE
VASCUTEK LTD
631809PCOL2
In Commercial Distribution

  • 05037881999647 ()

  • Branch diameter 9 mm
  • Length: 50 Centimeter
  • Lumen/Inner Diameter: 18 Millimeter
631809PCOL2

  • Synthetic vascular graft
Gelweave Gelatin Impregnated Woven Vascular Prosthesis 4 BRANCH PLEXUS
VASCUTEK LTD
73221288/10S
In Commercial Distribution

  • 05037881999579 ()

  • Branch length 20/20/20/25 cm
  • Branch diameter 12/8/8/10 mm
  • Length: 50 Centimeter
  • Lumen/Inner Diameter: 22 Millimeter
73221288/10S

  • Synthetic vascular graft
Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis VS040 BIFURCATE WITH SINGLE SIDE BRANCH
VASCUTEK LTD
631608/6RB
In Commercial Distribution

  • 05037881999463 ()

  • Branch length 10 cm
  • Lumen/Inner Diameter: 18 Millimeter
  • Length: 45 Centimeter
  • Branch diameter 6/6 mm
631608/6RB

  • Synthetic vascular graft
Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis VS040 BIFURCATE WITH DOUBLE SIDE BRANCHES
VASCUTEK LTD
631407/6/6RB
In Commercial Distribution

  • 05037881999456 ()

  • Lumen/Inner Diameter: 14 Millimeter
  • Branch length 10/10 cm
  • Length: 45 Centimeter
  • Branch diameter 7/6/6 mm
631407/6/6RB

  • Synthetic vascular graft
Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
VASCUTEK LTD
631608/6/6RB
In Commercial Distribution

  • 05037881999449 ()

  • Length: 45 Centimeter
  • Lumen/Inner Diameter: 16 Millimeter
  • Branch diameter 8/6/6 mm
631608/6/6RB

  • Synthetic vascular graft
Gelweave Gelatin Impregnated Woven Vascular Prosthesis VALSALVA
VASCUTEK LTD
730016ADP
In Commercial Distribution

  • 05037881999432 ()

  • Length: 15 Centimeter
  • Lumen/Inner Diameter: 16 Millimeter
730016ADP

  • Synthetic vascular graft
Gelweave Gelatin Impregnated Woven Vascular Prosthesis VALSALVA
VASCUTEK LTD
730018ADP
In Commercial Distribution

  • 05037881999425 ()

  • Length: 15 Centimeter
  • Lumen/Inner Diameter: 18 Millimeter
730018ADP

  • Synthetic vascular graft
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