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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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DRUGS OF ABUSE -50%
UTAK LABORATORIES, INC.
DAU SCR -50 SAFE
In Commercial Distribution

  • B80004644000021 ()
  • B80004644000020 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
IMMUNOSUPPRESSANTS QC 3
UTAK LABORATORIES, INC.
025090-0003
In Commercial Distribution

  • B80002509000033 ()
  • B80002509000030 ()

  • Total Volume: 10 Milliliter
IMMU 3 MAYO V2

  • Multiple immunosuppressant therapeutic drug monitoring IVD, control
IMMUNOSUPPRESSANTS QC 2
UTAK LABORATORIES, INC.
025090-0002
In Commercial Distribution

  • B80002509000020 ()
  • B80002509000023 ()

  • Total Volume: 10 Milliliter
IMMU 2 MAYO V2

  • Multiple immunosuppressant therapeutic drug monitoring IVD, control
IMMUNOSUPPRESSANTS QC 1
UTAK LABORATORIES, INC.
025090-0001
In Commercial Distribution

  • B80002509000013 ()
  • B80002509000010 ()

  • Total Volume: 10 Milliliter
IMMU 1 MAYO V2

  • Multiple immunosuppressant therapeutic drug monitoring IVD, control
Non-sterile, non-implantable wound dressing
Keranetics, Inc.
00
In Commercial Distribution

  • B789P00211 ()
  • B789P00210 ()

  • Total Volume: 5 Milliliter


  • Skin semi-occlusive dressing, non-antimicrobial
Non-sterile, non-implantable wound dressing
Keranetics, Inc.
00
In Commercial Distribution

  • B789P00201 ()
  • B789P00200 ()

  • Total Volume: 1 Fluid Ounce


  • Skin semi-occlusive dressing, non-antimicrobial
Sterile, non-implantable, water-based gelatinous (hydrogel) wound dressing
Keranetics, Inc.
00
In Commercial Distribution

  • B789P00100 ()
  • B789P00101 ()

  • Total Volume: 5 Milliliter


  • Wound hydrogel dressing, non-antimicrobial
ZINC PLUS LEVEL 2
UTAK LABORATORIES, INC.
ZINC+ 2 RBC F QDVA
In Commercial Distribution

  • B800ZINC2RBCFQDVA5 ()
  • B800ZINC2RBCFQDVA0 ()

  • Total Volume: 2 Milliliter
ZINC+ 2 RBC F QDVA

  • Multiple-type clinical chemistry analyte profile IVD, control
B800ZINC1RBCFQDVA0
UTAK LABORATORIES, INC.
ZINC+ 1 RBC F QDVA
In Commercial Distribution

  • B800ZINC1RBCFQDVA5 ()
  • B800ZINC1RBCFQDVA0 ()

  • Total Volume: 2 Milliliter
ZINC+ 1 RBC F QDVA

  • Multiple-type clinical chemistry analyte profile IVD, control
XYLAZINE LEVEL 3
UTAK LABORATORIES, INC.
XYL 3 U F YNHH
In Commercial Distribution

  • B800XYL3UFYNHH5 ()
  • B800XYL3UFYNHH0 ()

  • Total Volume: 2.5 Milliliter
XYL 3 U F YNHH

  • Multiple-type clinical chemistry analyte profile IVD, control
XYLAZINE LEVEL 2
UTAK LABORATORIES, INC.
XYL 2 U F YNHH
In Commercial Distribution

  • B800XYL2UFYNHH5 ()
  • B800XYL2UFYNHH0 ()

  • Total Volume: 2.5 Milliliter
XYL 2 U F YNHH

  • Multiple-type clinical chemistry analyte profile IVD, control
XYLAZINE LEVEL 1
UTAK LABORATORIES, INC.
XYL 1 U F YNHH
In Commercial Distribution

  • B800XYL1UFYNHH5 ()
  • B800XYL1UFYNHH0 ()

  • Total Volume: 2.5 Milliliter
XYL 1 U F YNHH

  • Multiple-type clinical chemistry analyte profile IVD, control
HUMAN WHOLE BLOOD POOL B
UTAK LABORATORIES, INC.
WB+ B F CTS 250
In Commercial Distribution

  • B800WBBFCTS2505 ()
  • B800WBBFCTS2500 ()

  • Total Volume: 250 Milliliter
WB+ B F CTS 250

  • Multiple-type clinical chemistry analyte profile IVD, control
HUMAN WHOLE BLOOD POOL A
UTAK LABORATORIES, INC.
WB+ A F CTS 250
In Commercial Distribution

  • B800WBAFCTS2505 ()
  • B800WBAFCTS2500 ()

  • Total Volume: 250 Milliliter
WB+ A F CTS 250

  • Multiple-type clinical chemistry analyte profile IVD, control
VORICONAZOLE LEVEL 3
UTAK LABORATORIES, INC.
VORI 3 DP QC DUMC
In Commercial Distribution

  • B800VORI3DPQCDUMC5 ()
  • B800VORI3DPQCDUMC0 ()

  • Total Volume: 3 Milliliter
VORI 3 DP QC DUMC

  • Multiple-type clinical chemistry analyte profile IVD, control
VORICONAZOLE LEVEL 2
UTAK LABORATORIES, INC.
VORI 2 DP QC DUMC
In Commercial Distribution

  • B800VORI2DPQCDUMC5 ()
  • B800VORI2DPQCDUMC0 ()

  • Total Volume: 3 Milliliter
VORI 2 DP QC DUMC

  • Multiple-type clinical chemistry analyte profile IVD, control
VORICONAZOLE LEVEL 1
UTAK LABORATORIES, INC.
VORI 1 DP QC DUM
In Commercial Distribution

  • B800VORI1DPQCDUMC5 ()
  • B800VORI1DPQCDUMC0 ()

  • Total Volume: 3 Milliliter
VORI 1 DP QC DUM

  • Multiple-type clinical chemistry analyte profile IVD, control
VORICONAZOLE PLUS 3
UTAK LABORATORIES, INC.
VOR+ 3 V2 S F UNC
In Commercial Distribution

  • B800VOR3V2SFUNC5 ()
  • B800VOR3V2SFUNC0 ()

  • Total Volume: 2 Milliliter
VOR+ 3 V2 S F UNC

  • Multiple-therapy therapeutic drug monitoring IVD, control
VORICONAZOLE PLUS 2
UTAK LABORATORIES, INC.
VOR+ 2 V2 S F UNC
In Commercial Distribution

  • B800VOR2V2SFUNC5 ()
  • B800VOR2V2SFUNC0 ()

  • Total Volume: 2 Milliliter
VOR+ 2 V2 S F UNC

  • Multiple-therapy therapeutic drug monitoring IVD, control
VORICONAZOLE PLUS 1
UTAK LABORATORIES, INC.
VOR+ 1 V2 S F UNC
In Commercial Distribution

  • B800VOR1V2SFUNC5 ()
  • B800VOR1V2SFUNC0 ()

  • Total Volume: 2 Milliliter
VOR+ 1 V2 S F UNC

  • Multiple-therapy therapeutic drug monitoring IVD, control
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