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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POSITIVE
UTAK LABORATORIES, INC.
POS S F BD
In Commercial Distribution

  • B800POSSFBD5 ()
  • B800POSSFBD0 ()

  • Total Volume: 1 Milliliter
POS S F BD

  • Multiple-type clinical chemistry analyte profile IVD, control
POSITIVE PLASMA
UTAK LABORATORIES, INC.
POS P F MSKCC
In Commercial Distribution

  • B800POSPFMSKCC5 ()
  • B800POSPFMSKCC0 ()

  • Total Volume: 500 Milliliter
POS P F MSKCC

  • Multiple-type clinical chemistry analyte profile IVD, control
POSITIVE DEFIBRINATED PLASMA
UTAK LABORATORIES, INC.
POS P F LSA
In Commercial Distribution

  • B800POSPFLSA5 ()
  • B800POSPFLSA0 ()

  • Total Volume: 500 Milliliter
POS P F LSA

  • Multiple-type clinical chemistry analyte profile IVD, control
PMV7UFMC
UTAK LABORATORIES, INC.
PM+ V7 U F MC
In Commercial Distribution

  • B800PMV7UFMC5 ()
  • B800PMV7UFMC0 ()

  • Total Volume: 25 Milliliter
PM+ V7 U F MC

  • Multiple-type clinical chemistry analyte profile IVD, control
PAIN MANAGEMENT PLUS
UTAK LABORATORIES, INC.
PM+ U F CCL
In Commercial Distribution

  • B800PMUFCCL5 ()
  • B800PMUFCCL0 ()

  • Total Volume: 5 Milliliter
PM+ U F CCL

  • Multiple drugs of abuse IVD, control
PM 25 V3 U F KP
UTAK LABORATORIES, INC.
PM 25 V3 U F KP
In Commercial Distribution

  • B800PM25V3UFKP5 ()
  • B800PM25V3UFKP0 ()

  • Total Volume: 2 Milliliter
PM 25 V3 U F KP

  • Multiple-type clinical chemistry analyte profile IVD, control
PAIN MANAGEMENT 100 NG/ML
UTAK LABORATORIES, INC.
PM 100 V3 U F KP
In Commercial Distribution

  • B800PM100V3UFKP5 ()
  • B800PM100V3UFKP0 ()

  • Total Volume: 2 Milliliter
PM 100 V3 U F KP

  • Multiple-type clinical chemistry analyte profile IVD, control
PETH LEVEL 7 V2
UTAK LABORATORIES, INC.
PETH 7 V2 WB F HFHS
In Commercial Distribution

  • B800PETH7V2WBFHFHS5 ()
  • B800PETH7V2WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 7 V2 WB F HFHS

  • Multiple drugs of abuse IVD, control
PETH LEVEL 6 V2
UTAK LABORATORIES, INC.
PETH 6 V2 WB F HFHS
In Commercial Distribution

  • B800PETH6V2WBFHFHS5 ()
  • B800PETH6V2WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 6 V2 WB F HFHS

  • Multiple drugs of abuse IVD, control
PETH LEVEL 5 V2
UTAK LABORATORIES, INC.
PETH 5 V2 WB F HFHS
In Commercial Distribution

  • B800PETH5V2WBFHFHS5 ()
  • B800PETH5V2WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 5 V2 WB F HFHS

  • Multiple drugs of abuse IVD, control
PETH LEVEL 4 V2
UTAK LABORATORIES, INC.
PETH 4 V2 WB F HFHS
In Commercial Distribution

  • B800PETH4V2WBFHFHS5 ()
  • B800PETH4V2WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 4 V2 WB F HFHS

  • Multiple drugs of abuse IVD, control
PETH LEVEL 3
UTAK LABORATORIES, INC.
PETH 3 WB F HFHS
In Commercial Distribution

  • B800PETH3WBFHFHS5 ()
  • B800PETH3WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 3 WB F HFHS

  • Multiple drugs of abuse IVD, control
PETH LEVEL 3
UTAK LABORATORIES, INC.
PETH 3 V3 WB F MAYO
In Commercial Distribution

  • B800PETH3V3WBFMAYO5 ()
  • B800PETH3V3WBFMAYO0 ()

  • Total Volume: 1 Milliliter
PETH 3 V3 WB F MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
PETH LEVEL 3
UTAK LABORATORIES, INC.
PETH 3 V2 WB F MAYO
In Commercial Distribution

  • B800PETH3V2WBFMAYO5 ()
  • B800PETH3V2WBFMAYO0 ()

  • Total Volume: 1 Milliliter
PETH 3 V2 WB F MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
PETH LEVEL 3 V2
UTAK LABORATORIES, INC.
PETH 3 V2 WB F HFHS
In Commercial Distribution

  • B800PETH3V2WBFHFHS5 ()
  • B800PETH3V2WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 3 V2 WB F HFHS

  • Multiple drugs of abuse IVD, control
PETH LEVEL 3
UTAK LABORATORIES, INC.
PETH 3 K2WB F UM
In Commercial Distribution

  • B800PETH3K2WBFUM5 ()
  • B800PETH3K2WBFUM0 ()

  • Total Volume: 1 Milliliter
PETH 3 K2WB F UM

  • Multiple drugs of abuse IVD, control
PETH LEVEL 2
UTAK LABORATORIES, INC.
PETH 2 WB F UCSD
In Commercial Distribution

  • B800PETH2WBFUCSD0 ()
  • B800PETH2WBFUCSD5 ()

  • Total Volume: 1 Milliliter
PETH 2 WB F UCSD

  • Multiple-type clinical chemistry analyte profile IVD, control
PETH LEVEL 2
UTAK LABORATORIES, INC.
PETH 2 WB F HFHS
In Commercial Distribution

  • B800PETH2WBFHFHS5 ()
  • B800PETH2WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 2 WB F HFHS

  • Multiple drugs of abuse IVD, control
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 2
UTAK LABORATORIES, INC.
PETH 2 K2WB F UM
In Commercial Distribution

  • B800PETH2K2WBFUM5 ()
  • B800PETH2K2WBFUM0 ()

  • Total Volume: 1 Milliliter
PETH 2 K2WB F UM

  • 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
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
OXYCODONE PLUS POSITIVE
UTAK LABORATORIES, INC.
OXY+BUP POS F CH
In Commercial Distribution

  • B800OXYBUPPOSFCH5 ()
  • B800OXYBUPPOSFCH0 ()

  • Total Volume: 10 Milliliter
OXY+BUP POS F CH

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

  • B800OXY2UFOL5 ()
  • B800OXY2UFOL0 ()

  • Total Volume: 25 Milliliter
OXY+ 2 U F OL

  • Multiple-type clinical chemistry analyte profile IVD, control
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
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 V2
UTAK LABORATORIES, INC.
OPIA 1 V2 U F CRL
In Commercial Distribution

  • B800OPIA1V2UFCRL5 ()
  • B800OPIA1V2UFCRL0 ()

  • Total Volume: 100 Milliliter
OPIATES LEVEL 1 V2

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

  • B800OPIA1UFUCD5 ()
  • B800OPIA1UFUCD0 ()

  • Total Volume: 2.5 Milliliter
OPIA 1 U F UCD

  • Multiple-type clinical chemistry analyte profile IVD, control
OPIATES LEVEL 3
UTAK LABORATORIES, INC.
OPI 3 U F VAMCI
In Commercial Distribution

  • B800OPI3UFVAMCI5 ()
  • B800OPI3UFVAMCI0 ()

  • Total Volume: 1 Milliliter
OPI 3 U F VAMCI

  • Multiple therapeutic drugs/drugs of abuse IVD, control
OPIATES LEVEL 2
UTAK LABORATORIES, INC.
OPI 2 U F VAMCI
In Commercial Distribution

  • B800OPI2UFVAMCI5 ()
  • B800OPI2UFVAMCI0 ()

  • Total Volume: 1 Milliliter
OPI 2 U F VAMCI

  • Multiple therapeutic drugs/drugs of abuse 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
OPIATES LEVEL 3 V2
UTAK LABORATORIES, INC.
OPAT L3 V2 MAYO
In Commercial Distribution

  • B800OPATL3V2MAYO5 ()
  • B800OPATL3V2MAYO0 ()

  • Total Volume: 1 Milliliter
OPAT L3 V2 MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
OPIATES LEVEL 2 V2
UTAK LABORATORIES, INC.
OPAT L2 V2 MAYO
In Commercial Distribution

  • B800OPATL2V2MAYO5 ()
  • B800OPATL2V2MAYO0 ()

  • Total Volume: 1 Milliliter
OPAT L2 V2 MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
ORAL TOXICOLOGY QC LEVEL 2
UTAK LABORATORIES, INC.
ORAL TOX QC2 5ML OF F GLML
In Commercial Distribution

  • B800OLTOXQC25MLOFFGLML5 ()
  • B800OLTOXQC25MLOFFGLML0 ()

  • Total Volume: 5 Milliliter


  • Multiple-type clinical chemistry analyte profile IVD, control
ORAL TOXICOLOGY QC LEVEL 1
UTAK LABORATORIES, INC.
ORAL TOX QC1 5ML OF F GLML
In Commercial Distribution

  • B800OLTOXQC15MLOFFGLML5 ()
  • B800OLTOXQC15MLOFFGLML0 ()

  • Total Volume: 5 Milliliter


  • Multiple-type clinical chemistry analyte profile IVD, control
NORDIAZEPAM 250 NG/ML
UTAK LABORATORIES, INC.
NORDIAZ 250 U F MED
In Commercial Distribution

  • B800NORDIAZ250UFMED5 ()
  • B800NORDIAZ250UFMED0 ()

  • Total Volume: 6 Milliliter
NORDIAZ 250 U F MED

  • Multiple-type clinical chemistry analyte profile IVD, control
NORDIAZEPAM 100 NG/ML
UTAK LABORATORIES, INC.
NORDIAZ 100 U F MED
In Commercial Distribution

  • B800NORDIAZ100UFMED5 ()
  • B800NORDIAZ100UFMED0 ()

  • Total Volume: 6 Milliliter
NORDIAZ 100 U F MED

  • Multiple-type clinical chemistry analyte profile IVD, control
NIFEDIPINE PLUS
UTAK LABORATORIES, INC.
NIF+ S F EBS
In Commercial Distribution

  • B800NIFSFEBS5 ()
  • B800NIFSFEBS0 ()

  • Total Volume: 1 Milliliter
NIF+ S F EBS

  • Multiple drugs of abuse IVD, control
NIDA LOW
UTAK LABORATORIES, INC.
NIDA LOW V2 F CRL
In Commercial Distribution

  • B800NIDALOWV2FCRL5 ()
  • B800NIDALOWV2FCRL0 ()

  • Total Volume: 120 Milliliter
NIDA LOW V2 F CRL

  • Multiple drugs of abuse IVD, control
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