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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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UTAK LABORATORIES, INC.
VLGR 2 S F MAYO
In Commercial Distribution

  • B80002509000060 ()
  • B80002509000061 ()
  • B80002509000062 ()
  • B80002509000063 ()
  • B80002509000066 ()
  • B80002509000067 ()
  • B80002509000068 ()
  • B80002509000069 ()


  • Multiple-therapy 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
BUSULFAN LEVEL 2
UTAK LABORATORIES, INC.
BUS 2 P F UK
In Commercial Distribution

  • B80001696000081 ()
  • B80001696000080 ()
  • B80001696000082 ()
  • B80001696000083 ()
  • B80001696000086 ()
  • B80001696000087 ()
  • B80001696000088 ()


  • Busulfan therapeutic drug monitoring IVD, control
METALS LEVEL 2
UTAK LABORATORIES, INC.
MET T 2 DP UK
In Commercial Distribution

  • B80001696000041 ()
  • B80001696000040 ()
  • B80001696000042 ()
  • B80001696000043 ()
  • B80001696000046 ()
  • B80001696000047 ()
  • B80001696000048 ()


  • Multiple heavy metal IVD, control
METALS LEVEL 2
UTAK LABORATORIES, INC.
MET T 2 WB UK
In Commercial Distribution

  • B80001696000021 ()
  • B80001696000020 ()
  • B80001696000022 ()
  • B80001696000023 ()
  • B80001696000026 ()
  • B80001696000027 ()
  • B80001696000028 ()


  • Multiple heavy metal IVD, control
DEXAMETHASONE LEVEL 2
UTAK LABORATORIES, INC.
DEXA 2 S F PM
In Commercial Distribution

  • B800DEXA2SFPM5 ()
  • B800DEXA2SFPM0 ()

  • Total Volume: 5 Milliliter
DEXA 2 S F PM

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU CALIBRATOR 2
UTAK LABORATORIES, INC.
DAU CAL 2 F IUH
In Commercial Distribution

  • B800DAUCAL2FIUH5 ()
  • B800DAUCAL2FIUH0 ()

  • Total Volume: 0.5 Milliliter
DAU CAL 2 F IUH

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU LEVEL 2
UTAK LABORATORIES, INC.
DAU 2 DTPM
In Commercial Distribution

  • B800DAU2DTPM0 ()

  • Total Volume: 10 Milliliter
DAU 2 DTPM

  • Multiple drugs of abuse IVD, control
DAU LEVEL 2
UTAK LABORATORIES, INC.
DAU 2 ABS
In Commercial Distribution

  • B800DAU2ABS0 ()

  • Total Volume: 10 Milliliter
DAU 2 ABS

  • Multiple drugs of abuse IVD, control
CREATININE LEVEL 2
UTAK LABORATORIES, INC.
CREAT 2 WB F LCG
In Commercial Distribution

  • B800CREAT2WBFLCG5 ()
  • B800CREAT2WBFLCG0 ()

  • Total Volume: 50 Milliliter
CREAT 2 WB F LCG

  • Multiple-type clinical chemistry analyte profile IVD, control
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