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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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
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
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 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 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
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
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 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 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 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 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 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 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 ADX
In Commercial Distribution

  • B800NIC1UFADX5 ()
  • B800NIC1UFADX0 ()

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

  • 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
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
MYCOPHENOLIC ACID LEVEL 5
UTAK LABORATORIES, INC.
MPA 5 S MAYO
In Commercial Distribution

  • B800MPA5SMAYO5 ()
  • B800MPA5SMAYO0 ()

  • Total Volume: .25 Milliliter
MPA 5 S MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
MYCOPHENOLIC ACID LEVEL 3
UTAK LABORATORIES, INC.
MPA 3 S MAYO
In Commercial Distribution

  • B800MPA3SMAYO5 ()
  • B800MPA3SMAYO0 ()

  • Total Volume: .25 Milliliter
MPA 3 S MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
MPA PLUS LEVEL 2
UTAK LABORATORIES, INC.
MPA+ 2 P V1 F UM
In Commercial Distribution

  • B800MPA2PV1FUM5 ()
  • B800MPA2PV1FUM0 ()

  • Total Volume: 0.5 Milliliter
MPA+ 2 P V1 F UM

  • Multiple drugs of abuse IVD, control
MPA LEVEL 2
UTAK LABORATORIES, INC.
MPA 2 DP F FUMC
In Commercial Distribution

  • B800MPA2DPFFUMC5 ()
  • B800MPA2DPFFUMC0 ()

  • Total Volume: .5 Microliter
MPA 2 DP F FUMC

  • Multiple-therapy therapeutic drug monitoring IVD, control
MYCOPHENOLIC ACID LEVEL 1
UTAK LABORATORIES, INC.
MPA 1 S MAYO
In Commercial Distribution

  • B800MPA1SMAYO5 ()
  • B800MPA1SMAYO0 ()

  • Total Volume: .25 Milliliter
MPA 1 S MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
MPA PLUS LEVEL 1
UTAK LABORATORIES, INC.
MPA+ 1 P V1 F UM
In Commercial Distribution

  • B800MPA1PV1FUM5 ()
  • B800MPA1PV1FUM0 ()

  • Total Volume: 0.5 Milliliter
MPA+ 1 P V1 F UM

  • Multiple drugs of abuse IVD, control
MPA LEVEL 1
UTAK LABORATORIES, INC.
MPA 1 DP F FUMC
In Commercial Distribution

  • B800MPA1DPFFUMC5 ()
  • B800MPA1DPFFUMC0 ()

  • Total Volume: .5 Microliter
MPA 1 DP F FUMC

  • Multiple-therapy therapeutic drug monitoring IVD, control
MORPHINE PLUS
UTAK LABORATORIES, INC.
MOR+ U F VTS
In Commercial Distribution

  • B800MORUFVTS5 ()
  • B800MORUFVTS0 ()

  • Total Volume: 2 Milliliter
MOR+ U F VTS

  • Multiple-type clinical chemistry analyte profile IVD, control
MORPHINE GLUCURONIDE PLUS V4
UTAK LABORATORIES, INC.
MOR GLUC+ V4 U F USDTL
In Commercial Distribution

  • B800MORGLUCV4UFUSDTL5 ()
  • B800MORGLUCV4UFUSDTL0 ()

  • Total Volume: 2.5 Milliliter
MOR GLUC+ V4 U F USDTL

  • Multiple-type clinical chemistry analyte profile IVD, control
MORPHINE GLUCURONIDE
UTAK LABORATORIES, INC.
MOR GLUC U HCMC
In Commercial Distribution

  • B800MORGLUCUHCMC5 ()
  • B800MORGLUCUHCMC0 ()

  • Total Volume: 5 Milliliter
MOR GLUC U HCMC

  • Multiple-type clinical chemistry analyte profile IVD, control
MORPHINE GLUCURONIDE PLUS
UTAK LABORATORIES, INC.
MOR GLUC+ U F USDTL
In Commercial Distribution

  • B800MORGLUCUFUSDTL5 ()
  • B800MORGLUCUFUSDTL0 ()

  • Total Volume: 50 Milliliter
MOR GLUC+ U F USDTL

  • Multiple drugs of abuse IVD, control
MMA 500 NMOL/L
UTAK LABORATORIES, INC.
MMA 500 F QD
In Commercial Distribution

  • B800MMA500FQD5 ()
  • B800MMA500FQD0 ()

  • Total Volume: 1 Milliliter
MMA 500 F QD

  • Multiple-type clinical chemistry analyte profile IVD, control
METHYLMALONIC ACID PLUS LEVEL 2
UTAK LABORATORIES, INC.
MMA+ 2 S F UCSD
In Commercial Distribution

  • B800MMA2SFUCSD5 ()
  • B800MMA2SFUCSD0 ()

  • Total Volume: 1 Milliliter
MMA+ 2 S F UCSD

  • Multiple-type clinical chemistry analyte profile IVD, control
MMA 200 NMOL/L
UTAK LABORATORIES, INC.
MMA 200 F QD
In Commercial Distribution

  • B800MMA200FQD5 ()
  • B800MMA200FQD0 ()

  • Total Volume: 1 Milliliter
MMA 200 F QD

  • Multiple-type clinical chemistry analyte profile IVD, control
METHYLMALONIC ACID PLUS LEVEL 1
UTAK LABORATORIES, INC.
MMA+ 1 S F UCSD
In Commercial Distribution

  • B800MMA1SFUCSD5 ()
  • B800MMA1SFUCSD0 ()

  • Total Volume: 1 Milliliter
MMA+ 1 S F UCSD

  • Multiple-type clinical chemistry analyte profile IVD, control
METHYLMALONIC ACID 10 UMOL/L
UTAK LABORATORIES, INC.
MMA 10 S F KPRICH
In Commercial Distribution

  • B800MMA10SFKPRICH5 ()
  • B800MMA10SFKPRICH0 ()

  • Total Volume: 5 Milliliter
MMA 10 S F KPRICH

  • Multiple-type clinical chemistry analyte profile IVD, control
MMA 10500 NMOL/L
UTAK LABORATORIES, INC.
MMA 10500 SJCLW
In Commercial Distribution

  • B800MMA10500SJCLW0 ()
  • B800MMA10500SJCLW5 ()

  • Total Volume: 25 Milliliter
MMA 10500 SJCLW

  • Multiple-type clinical chemistry analyte profile IVD, control
MITRAGYNINE PLUS
UTAK LABORATORIES, INC.
MIT+ U F OT
In Commercial Distribution

  • B800MITUFOT5 ()
  • B800MITUFOT0 ()

  • Total Volume: 1 Milliliter
MIT+ U F OT

  • Multiple-type clinical chemistry analyte profile IVD, control
TCME MISCELLANEOUS
UTAK LABORATORIES, INC.
MISC M TCME
In Commercial Distribution

  • B800MISCMTCME5 ()
  • B800MISCMTCME0 ()

  • Total Volume: 50 Milliliter
MISC M TCME

  • Multiple-type clinical chemistry analyte profile IVD, control
MIRTAZEPINE 15 NG/ML
UTAK LABORATORIES, INC.
MIRT 15 F WB NMS
In Commercial Distribution

  • B800MIRT15FWBNMS5 ()
  • B800MIRT15FWBNMS0 ()

  • Total Volume: 5 Milliliter
MIRT 15 F WB NMS

  • Multiple-type clinical chemistry analyte profile IVD, control
METALS QC LEVEL 2
UTAK LABORATORIES, INC.
MET QC 2 WB PAML
In Commercial Distribution

  • B800METQC2WBPAML5 ()
  • B800METQC2WBPAML0 ()

  • Total Volume: 5 Milliliter
MET QC 2 WB PAML

  • Multiple-type clinical chemistry analyte profile IVD, control
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