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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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OXYCODONE PLUS LEVEL 1
UTAK LABORATORIES, INC.
OXY+ 1 U F OL
In Commercial Distribution

  • B800OXY1UFOL5 ()
  • B800OXY1UFOL0 ()

  • Total Volume: 25 Milliliter
OXY+ 1 U F OL

  • Multiple-type clinical chemistry analyte profile IVD, control
OXAZEPAM 500 NG/ML
UTAK LABORATORIES, INC.
OXAZ 500 U F PM
In Commercial Distribution

  • B800OXAZ500UFPM5 ()
  • B800OXAZ500UFPM0 ()

  • Total Volume: 5 Milliliter
OXAZ 500 U F PM

  • Multiple-therapy therapeutic drug monitoring IVD, control
OPIATES CALIBRATOR LEVEL 7
UTAK LABORATORIES, INC.
OPI U CAL 7 UNC
In Commercial Distribution

  • B800OPIUCAL7UNC5 ()
  • B800OPIUCAL7UNC0 ()

  • Total Volume: 2 Milliliter
OPI U CAL 7 UNC

  • Multiple therapeutic drugs/drugs of abuse IVD, control
OPIATES CALIBRATOR LEVEL 5
UTAK LABORATORIES, INC.
OPI U CAL 5 UNC
In Commercial Distribution

  • B800OPIUCAL5UNC5 ()
  • B800OPIUCAL5UNC0 ()

  • Total Volume: 2 Milliliter
OPI U CAL 5 UNC

  • Multiple therapeutic drugs/drugs of abuse IVD, control
OPIATES CALIBRATOR LEVEL 3
UTAK LABORATORIES, INC.
OPI U CAL 3 UNC
In Commercial Distribution

  • B800OPIUCAL3UNC5 ()
  • B800OPIUCAL3UNC0 ()

  • Total Volume: 2 Milliliter
OPI U CAL 3 UNC

  • Multiple therapeutic drugs/drugs of abuse IVD, control
OPIATES PLUS MIX
UTAK LABORATORIES, INC.
OPI+ MIX ET
In Commercial Distribution

  • B800OPIMIXET5 ()
  • B800OPIMIXET0 ()

  • Total Volume: 20 Milliliter
OPI+ MIX ET

  • Multiple drugs of abuse IVD, control
OPIATES MID
UTAK LABORATORIES, INC.
OPIA MID U UNC
In Commercial Distribution

  • B800OPIAMIDUUNC5 ()
  • B800OPIAMIDUUNC0 ()

  • Total Volume: 2 Milliliter
OPIA MID U UNC

  • Multiple-type clinical chemistry analyte profile IVD, control
OPIATES LOW
UTAK LABORATORIES, INC.
OPIA LOW U UNC
In Commercial Distribution

  • B800OPIALOWUUNC5 ()
  • B800OPIALOWUUNC0 ()

  • Total Volume: 2 Milliliter
OPIA LOW U UNC

  • Multiple-type clinical chemistry analyte profile IVD, control
OPIATES HIGH
UTAK LABORATORIES, INC.
OPIA HIGH U UNC
In Commercial Distribution

  • B800OPIAHIGHUUNC5 ()
  • B800OPIAHIGHUUNC0 ()

  • Total Volume: 2 Milliliter
OPIA HIGH U UNC

  • Multiple-type clinical chemistry analyte profile IVD, control
TCME OPIATES PLUS BENZO
UTAK LABORATORIES, INC.
OPIA+ BENZO M V3
In Commercial Distribution

  • B800OPIABENZOMV35 ()
  • B800OPIABENZOMV30 ()

  • Total Volume: 50 Milliliter
OPIA+ BENZO M V3

  • Multiple-type clinical chemistry analyte profile IVD, control
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