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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QC LEVEL 1 V3
UTAK LABORATORIES, INC.
QC V3 C-1 U F AP
In Commercial Distribution

  • B800QCV3C1UFAP5 ()
  • B800QCV3C1UFAP0 ()

  • Total Volume: 5 Milliliter
QC V3 C-1 U F AP

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE QC A LEVEL 3
UTAK LABORATORIES, INC.
QC A3 OF F WHPM
In Commercial Distribution

  • B800QCA3OFFWHPM5 ()
  • B800QCA3OFFWHPM0 ()

  • Total Volume: 3 Milliliter
QC A3 OF F WHPM

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE QC A LEVEL 2
UTAK LABORATORIES, INC.
QC A2 OF F WHPM
In Commercial Distribution

  • B800QCA2OFFWHPM5 ()
  • B800QCA2OFFWHPM0 ()

  • Total Volume: 3 Milliliter
QC A2 OF F WHPM

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE QC A LEVEL 1
UTAK LABORATORIES, INC.
QC A1 OF F WHPM
In Commercial Distribution

  • B800QCA1OFFWHPM5 ()
  • B800QCA1OFFWHPM0 ()

  • Total Volume: 3 Milliliter
QC A1 OF F WHPM

  • Multiple-type clinical chemistry analyte profile IVD, control
QUALITY CONTROL 1
UTAK LABORATORIES, INC.
QC 1 U F OSUMC
In Commercial Distribution

  • B800QC1UFOSUMC5 ()
  • B800QC1UFOSUMC0 ()

  • Total Volume: 10 Milliliter
QC 1 U F OSUMC

  • Multiple drugs of abuse IVD, control
P/Z QC V12 HIGH
UTAK LABORATORIES, INC.
P/Z QC V12 H U F ML
In Commercial Distribution

  • B800PZQCV12HUFML5 ()
  • B800PZQCV12HUFML0 ()

  • Total Volume: 17 Milliliter
P/Z QC V12 H U F ML

  • Multiple therapeutic drugs/drugs of abuse IVD, control
PTZH C3
UTAK LABORATORIES, INC.
PTZH L3 MAYO
In Commercial Distribution

  • B800PTZHL3MAYO5 ()
  • B800PTZHL3MAYO0 ()

  • Total Volume: 0.75 Milliliter
PTZH L3 MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
PTZH C1
UTAK LABORATORIES, INC.
PTZH L1 MAYO
In Commercial Distribution

  • B800PTZHL1MAYO5 ()
  • B800PTZHL1MAYO0 ()

  • Total Volume: 0.75 Milliliter
PTZH L1 MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
PSYCH PANEL LEVEL 2
UTAK LABORATORIES, INC.
PSYCH 2 F M ACL
In Commercial Distribution

  • B800PSYCH2FMACL5 ()
  • B800PSYCH2FMACL0 ()

  • Total Volume: 3 Milliliter
PSYCH 2 F M ACL

  • Multiple-type clinical chemistry analyte profile IVD, control
PREGNENOLONE PLUS
UTAK LABORATORIES, INC.
REGN+ SMX S F PC
In Commercial Distribution

  • B800PREGNSMXSFPC5 ()
  • B800PREGNSMXSFPC0 ()

  • Total Volume: 5 Milliliter
REGN+ SMX S F PC

  • Multiple-type clinical chemistry analyte profile IVD, control
POSITIVE WHOLE BLOOD
UTAK LABORATORIES, INC.
POS WB F TDPS
In Commercial Distribution

  • B800POSWBFTDPS0 ()

  • Total Volume: 250 Milliliter
POS WB F TDPS

  • Multiple drugs of abuse IVD, control
POSITIVE WHOLE BLOOD
UTAK LABORATORIES, INC.
POS WB F JH
In Commercial Distribution

  • B800POSWBFJH5 ()
  • B800POSWBFJH0 ()

  • Total Volume: 250 Milliliter
POS WB F JH

  • 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
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
OXY THC LEVEL 2
UTAK LABORATORIES, INC.
OXY THC 2 F OL
In Commercial Distribution

  • B800OXYTHC2FOL5 ()
  • B800OXYTHC2FOL0 ()

  • Total Volume: 25 Milliliter
OXY THC 2 F OL

  • Multiple-type clinical chemistry analyte profile IVD, control
OXY THC LEVEL 1
UTAK LABORATORIES, INC.
OXY THC 1 F OL
In Commercial Distribution

  • B800OXYTHC1FOL5 ()
  • B800OXYTHC1FOL0 ()

  • Total Volume: 25 Milliliter
OXY THC 1 F OL

  • Multiple-type clinical chemistry analyte profile 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 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 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 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 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
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 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
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 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 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
OPIATE QC MIX
UTAK LABORATORIES, INC.
OPIA QC L FCCO
In Commercial Distribution

  • B800OPIAQCLFCCO5 ()
  • B800OPIAQCLFCCO0 ()

  • Total Volume: 25 Milliliter
OPIA QC L FCCO

  • Multiple-therapy therapeutic drug monitoring 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
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