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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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PETH LEVEL 2 V2
UTAK LABORATORIES, INC.
PETH 2 V2 WB F HFHS
In Commercial Distribution

  • B800PETH2V2WBFHFHS5 ()
  • B800PETH2V2WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 2 V2 WB F HFHS

  • Multiple drugs of abuse IVD, control
PETH LEVEL 1
UTAK LABORATORIES, INC.
PETH 1 WB F HFHS
In Commercial Distribution

  • B800PETH1WBFHFHS5 ()
  • B800PETH1WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 1 WB F HFHS

  • Multiple drugs of abuse IVD, control
PETH LEVEL 1 V2
UTAK LABORATORIES, INC.
PETH 1 V2 WB F HFHS
In Commercial Distribution

  • B800PETH1V2WBFHFHS5 ()
  • B800PETH1V2WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 1 V2 WB F HFHS

  • Multiple drugs of abuse IVD, control
OXYCODONE PLUS LEVEL 2
UTAK LABORATORIES, INC.
OXY+ 2 WB F QDCHANT
In Commercial Distribution

  • B800OXY2WBFQDCHANT5 ()
  • B800OXY2WBFQDCHANT0 ()

  • Total Volume: 2 Microliter
OXY+ 2 WB F QDCHANT

  • Multiple therapeutic drugs/drugs of abuse IVD, control
OXYCODONE PLUS LEVEL 2
UTAK LABORATORIES, INC.
OXY+ 2 S F QDCHANT
In Commercial Distribution

  • B800OXY2SFQDCHANT5 ()
  • B800OXY2SFQDCHANT0 ()

  • Total Volume: 2 Milliliter
OXY+ 2 S F QDCHANT

  • Multiple therapeutic drugs/drugs of abuse IVD, control
OXYCODONE PLUS LEVEL 1
UTAK LABORATORIES, INC.
OXY+ 1 WB F QDCHANT
In Commercial Distribution

  • B800OXY1WBFQDCHANT5 ()
  • B800OXY1WBFQDCHANT0 ()

  • Total Volume: 2 Milliliter
OXY+ 1 WB F QDCHANT

  • Multiple therapeutic drugs/drugs of abuse IVD, control
OXYCODONE PLUS LEVEL 1
UTAK LABORATORIES, INC.
OXY+ 1 S F QDCHANT
In Commercial Distribution

  • B800OXY1SFQDCHANT5 ()
  • B800OXY1SFQDCHANT0 ()

  • Total Volume: 2 Milliliter
OXY+ 1 S F QDCHANT

  • Multiple therapeutic drugs/drugs of abuse IVD, control
OXAZEPAM GLUCURONIDE
UTAK LABORATORIES, INC.
OXA GLUC V2 U F HCMC
In Commercial Distribution

  • B800OXAGLUCV2UFHCMC5 ()
  • B800OXAGLUCV2UFHCMC0 ()

  • Total Volume: 2 Milliliter
OXA GLUC V2 U F HCMC

  • Multiple drugs of abuse 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 6
UTAK LABORATORIES, INC.
OPI U CAL 6 UNC
In Commercial Distribution

  • B800OPIUCAL6UNC5 ()
  • B800OPIUCAL6UNC0 ()

  • Total Volume: 2 Milliliter
OPI U CAL 6 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 4
UTAK LABORATORIES, INC.
OPI U CAL 4 UNC
In Commercial Distribution

  • B800OPIUCAL4UNC5 ()
  • B800OPIUCAL4UNC0 ()

  • Total Volume: 2 Milliliter
OPI U CAL 4 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 CALIBRATOR LEVEL 2
UTAK LABORATORIES, INC.
OPI U CAL 2 UNC
In Commercial Distribution

  • B800OPIUCAL2UNC5 ()
  • B800OPIUCAL2UNC0 ()

  • Total Volume: 2 Milliliter
OPI U CAL 2 UNC

  • Multiple therapeutic drugs/drugs of abuse IVD, control
OPIATES CALIBRATOR LEVEL 1
UTAK LABORATORIES, INC.
OPI U CAL 1 UNC
In Commercial Distribution

  • B800OPIUCAL1UNC5 ()
  • B800OPIUCAL1UNC0 ()

  • Total Volume: 2 Milliliter
OPI U CAL 1 UNC

  • Multiple therapeutic drugs/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
OPIATES CALIBRATOR 4
UTAK LABORATORIES, INC.
OPIA CAL 4 U IMMU
In Commercial Distribution

  • B800OPIACAL4UIMMU0 ()

  • Total Volume: 2 Milliliter
OPIA CAL 4 U IMMU

  • Multiple-therapy therapeutic drug monitoring IVD, control
OPIATES CALIBRATOR 3
UTAK LABORATORIES, INC.
OPIA CAL 3 U IMMU
In Commercial Distribution

  • B800OPIACAL3UIMMU0 ()

  • Total Volume: 2 Milliliter
OPIA CAL 3 U IMMU

  • Multiple-therapy therapeutic drug monitoring IVD, control
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