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
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
NIDA CUTOFF
UTAK LABORATORIES, INC.
NIDA CUT V2 F CRL
In Commercial Distribution

  • B800NIDACUTV2FCRL5 ()
  • B800NIDACUTV2FCRL0 ()

  • Total Volume: 120 Milliliter
NIDA CUT V2 F CRL

  • Multiple drugs of abuse IVD, control
NICOTINE PLUS
UTAK LABORATORIES, INC.
NIC+ U F UCSF
In Commercial Distribution

  • B800NICUFUCSF5 ()
  • B800NICUFUCSF0 ()

  • Total Volume: 5 Milliliter
NIC+ U F UCSF

  • Multiple urine analyte IVD, control
NICOTINE URINE LEVEL 3
UTAK LABORATORIES, INC.
NICOU L3 V2 MAYO
In Commercial Distribution

  • B800NICOUL3V2MAYO5 ()
  • B800NICOUL3V2MAYO0 ()

  • Total Volume: 0.5 Milliliter
NICOU L3 V2 MAYO

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

  • B800NICOUL2V2MAYO5 ()
  • B800NICOUL2V2MAYO0 ()

  • Total Volume: 0.5 Milliliter
NICOU L2 V2 MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
NICOTINE URINE LEVEL 1
UTAK LABORATORIES, INC.
NICOU L1 V2 MAYO
In Commercial Distribution

  • B800NICOUL1V2MAYO5 ()
  • B800NICOUL1V2MAYO0 ()

  • Total Volume: 0.5 Milliliter
NICOU L1 V2 MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
NICOTINE PLUS LEVEL 2
UTAK LABORATORIES, INC.
NICO+ 2 F QC LC
In Commercial Distribution

  • B800NICO2FQCLC5 ()
  • B800NICO2FQCLC0 ()

  • Total Volume: 5 Milliliter
NICO+ 2 F QC LC

  • Multiple-type clinical chemistry analyte profile IVD, control
NICOTINE PLUS LEVEL 1
UTAK LABORATORIES, INC.
NICO+ 1 V2 F QC LC
In Commercial Distribution

  • B800NICO1V2FQCLC5 ()
  • B800NICO1V2FQCLC0 ()

  • Total Volume: 5 Milliliter
NICO+ 1 V2 F QC LC

  • Multiple-type clinical chemistry analyte profile IVD, control
NICOTINE PLUS LEVEL 1
UTAK LABORATORIES, INC.
NICO+ 1 F QC LC
In Commercial Distribution

  • B800NICO1FQCLC5 ()
  • B800NICO1FQCLC0 ()

  • Total Volume: 5 Milliliter
NICO+ 1 F QC LC

  • Multiple-type clinical chemistry analyte profile IVD, control
NICOTINE PLUS 1200 NG/ML V3
UTAK LABORATORIES, INC.
NICO+ 1200 V3 U F UWHC
In Commercial Distribution

  • B800NICO1200V3UFUWHC5 ()
  • B800NICO1200V3UFUWHC0 ()

  • Total Volume: 5 Milliliter
NICO+ 1200 V3 U F UWHC

  • Multiple-type clinical chemistry analyte profile IVD, control
NICOTINE PLUS 1200 NG/ML V2
UTAK LABORATORIES, INC.
NICO+ 1200 V2 U F UWHC
In Commercial Distribution

  • B800NICO1200V2UFUWHC5 ()
  • B800NICO1200V2UFUWHC0 ()

  • Total Volume: 5 Milliliter
NICO+ 1200 V2 U F UWHC

  • Multiple-type clinical chemistry analyte profile IVD, control
NICOTINE PLUS 100 NG/ML V3
UTAK LABORATORIES, INC.
NICO+ 100 V3 U F UWHC
In Commercial Distribution

  • B800NICO100V3UFUWHC5 ()
  • B800NICO100V3UFUWHC0 ()

  • Total Volume: 5 Milliliter
NICO+ 100 V3 U F UWHC

  • Multiple-type clinical chemistry analyte profile IVD, control
NICOTINE PLUS 100 NG/ML V2
UTAK LABORATORIES, INC.
NICO+ 100 V2 U F UWHC
In Commercial Distribution

  • B800NICO100V2UFUWHC0 ()
  • B800NICO100V2UFUWHC5 ()

  • Total Volume: 5 Milliliter
NICO+ 100 V2 U F UWHC

  • Multiple-type clinical chemistry analyte profile IVD, control
NICOTINE PLUS LEVEL 2
UTAK LABORATORIES, INC.
NIC+ L2 U F PM
In Commercial Distribution

  • B800NICL2UFPM5 ()
  • B800NICL2UFPM0 ()

  • Total Volume: 3 Milliliter
NIC+ L2 U F PM

  • Multiple-type clinical chemistry analyte profile IVD, control
NICOTINE PLUS LEVEL 1
UTAK LABORATORIES, INC.
NIC+ L1 U F PM
In Commercial Distribution

  • B800NICL1UFPM5 ()
  • B800NICL1UFPM0 ()

  • Total Volume: 3 Milliliter
NIC+ L1 U F PM

  • Multiple-type clinical chemistry analyte profile IVD, control
NICOTINE PLUS LEVEL 3
UTAK LABORATORIES, INC.
NIC+ 3 U F UHCMC
In Commercial Distribution

  • B800NIC3UFUHCMC5 ()
  • B800NIC3UFUHCMC0 ()

  • Total Volume: 0.5 Milliliter
NIC+ 3 U F UHCMC

  • Multiple-type clinical chemistry analyte profile IVD, control
NICOTINE PLUS LEVEL 2
UTAK LABORATORIES, INC.
NIC+ 2 U F UHCMC
In Commercial Distribution

  • B800NIC2UFUHCMC0 ()

  • Total Volume: 0.5 Milliliter
NIC+ 2 U F UHCMC

  • Multiple-type clinical chemistry analyte profile IVD, control
NICOTINE PLUS LEVEL 2
UTAK LABORATORIES, INC.
NIC+ 2 U F ADX
In Commercial Distribution

  • B800NIC2UFADX5 ()
  • B800NIC2UFADX0 ()

  • Total Volume: 3 Milliliter
NIC+ 2 U F ADX

  • Multiple-type clinical chemistry analyte profile IVD, control
NICOTINE PLUS LEVEL 1
UTAK LABORATORIES, INC.
NIC+ 1 U F UHCMC
In Commercial Distribution

  • B800NIC1UFUHCMC5 ()
  • B800NIC1UFUHCMC0 ()

  • Total Volume: 0.5 Milliliter
NIC+ 1 U F UHCMC

  • Multiple-type clinical chemistry analyte profile IVD, control
NICOTINE PLUS LEVEL 1
UTAK LABORATORIES, INC.
NIC+ 1 U F ADX
In Commercial Distribution

  • B800NIC1UFADX5 ()
  • B800NIC1UFADX0 ()

  • Total Volume: 3 Milliliter
NIC+ 1 U F ADX

  • Multiple-type clinical chemistry analyte profile IVD, control
NEGATIVE CONTROL
UTAK LABORATORIES, INC.
NEG CON 150 WB F EBS
In Commercial Distribution

  • B800NEGCON150WBFEBS5 ()
  • B800NEGCON150WBFEBS0 ()

  • Total Volume: 3 Milliliter
NEG CON 150 WB F EBS

  • Multiple-type clinical chemistry analyte profile IVD, control
MISCELLANEOUS PANEL
UTAK LABORATORIES, INC.
MP U F SCL
In Commercial Distribution

  • B800MPUFSCL5 ()
  • B800MPUFSCL0 ()

  • Total Volume: 5 Milliliter
MP U F SCL

  • Multiple therapeutic drugs/drugs of abuse IVD, control
MISCELLANEOUS PANEL
UTAK LABORATORIES, INC.
MP U F LSA
In Commercial Distribution

  • B800MPUFLSA5 ()
  • B800MPUFLSA0 ()

  • Total Volume: 10 Milliliter
MP U F LSA

  • Multiple therapeutic drugs/drugs of abuse IVD, control
MYCOPHENOLIC ACID GLUCURONIDE LEVEL 4
UTAK LABORATORIES, INC.
MPAG 4 S MAYO
In Commercial Distribution

  • B800MPAG4SMAYO0 ()

  • Total Volume: .25 Milliliter
MPAG 4 S MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
MYCOPHENOLIC ACID GLUCURONIDE LEVEL 2
UTAK LABORATORIES, INC.
MPAG 2 S MAYO
In Commercial Distribution

  • B800MPAG2SMAYO5 ()
  • B800MPAG2SMAYO0 ()

  • Total Volume: .25 Milliliter
MPAG 2 S MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
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