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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 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
PETH LEVEL 1
UTAK LABORATORIES, INC.
PETH 1 K2WB F UM
In Commercial Distribution

  • B800PETH1K2WBFUM5 ()
  • B800PETH1K2WBFUM0 ()

  • Total Volume: 1 Milliliter
PETH 1 K2WB F UM

  • Multiple drugs of abuse IVD, control
OPIATES PLUS
UTAK LABORATORIES, INC.
OPIA+ WB WC
In Commercial Distribution

  • B800OPIAWBWC5 ()
  • B800OPIAWBWC0 ()

  • Total Volume: 5 Milliliter
OPIA+ WB WC

  • 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 LEVEL 2 V2
UTAK LABORATORIES, INC.
OPIA 2 V2 U F CRL
In Commercial Distribution

  • B800OPIA2V2UFCRL5 ()
  • B800OPIA2V2UFCRL0 ()

  • Total Volume: 100 Milliliter
OPIA 2 V2 U F CRL

  • Multiple-type clinical chemistry analyte profile IVD, control
OPIATES LEVEL 2
UTAK LABORATORIES, INC.
OPIA 2 U F UCD
In Commercial Distribution

  • B800OPIA2UFUCD5 ()
  • B800OPIA2UFUCD0 ()

  • Total Volume: 2.5 Milliliter
OPIA 2 U F UCD

  • Multiple-type clinical chemistry analyte profile IVD, control
OPIATES URINE QC
UTAK LABORATORIES, INC.
OPIA 1 V2 U WHM
In Commercial Distribution

  • B800OPIA1V2UWHM5 ()
  • B800OPIA1V2UWHM0 ()

  • Total Volume: 5 Milliliter
OPIA 1 V2 U WHM

  • Multiple-type clinical chemistry analyte profile IVD, control
OPIATES LEVEL 1
UTAK LABORATORIES, INC.
OPI 1 U F VAMCI
In Commercial Distribution

  • B800OPI1UFVAMCI5 ()
  • B800OPI1UFVAMCI0 ()

  • Total Volume: 1 Milliliter
OPI 1 U F VAMCI

  • Multiple therapeutic drugs/drugs of abuse IVD, control
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