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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VOLATILES 0.1 G/DL
UTAK LABORATORIES, INC.
VOL WB V2 F FCL
In Commercial Distribution

  • B800VOLWBV2FFCL5 ()
  • B800VOLWBV2FFCL0 ()

  • Total Volume: 0.5 Milliliter
VOL WB V2 F FCL

  • Multiple drugs of abuse IVD, control
THC PLUS LEVEL 2
UTAK LABORATORIES, INC.
THC+ 2 V2 WB NJSP
In Commercial Distribution

  • B800THC2V2WBNJSP5 ()
  • B800THC2V2WBNJSP0 ()

  • Total Volume: 5 Milliliter
THC+ 2 V2 WB NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control
THC PLUS LEVEL 2
UTAK LABORATORIES, INC.
THC+ 2 V2 U NJSP
In Commercial Distribution

  • B800THC2V2UNJSP5 ()
  • B800THC2V2UNJSP0 ()

  • Total Volume: 5 Milliliter
THC+ 2 V2 U NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control
THC PLUS LEVEL 1
UTAK LABORATORIES, INC.
THC+ 1 V2 WB NJSP
In Commercial Distribution

  • B800THC1V2WBNJSP5 ()
  • B800THC1V2WBNJSP0 ()

  • Total Volume: 5 Milliliter
THC+ 1 V2 WB NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control
THC PLUS LEVEL 1
UTAK LABORATORIES, INC.
THC+ 1 V2 U NJSP
In Commercial Distribution

  • B800THC1V2UNJSP5 ()
  • B800THC1V2UNJSP0 ()

  • Total Volume: 5 Milliliter
THC+ 1 V2 U NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control
VOLATILES LEVEL 2
UTAK LABORATORIES, INC.
VOL 2 V2 S MAYO
In Commercial Distribution

  • B800VOL2V2SMAYO5 ()
  • B800VOL2V2SMAYO0 ()

  • Total Volume: 5 Milliliter
VOL 2 V2 S MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
VOLATILES LEVEL 1
UTAK LABORATORIES, INC.
VOL 1 V2 S MAYO
In Commercial Distribution

  • B800VOL1V2SMAYO5 ()
  • B800VOL1V2SMAYO0 ()

  • Total Volume: 5 Milliliter
VOL 1 V2 S MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
PENTOBARBITAL LEVEL 2
UTAK LABORATORIES, INC.
PENTO 2 V2 S BH
In Commercial Distribution

  • B800PENTO2V2SBH5 ()
  • B800PENTO2V2SBH0 ()

  • Total Volume: 5 Milliliter
PENTO 2 V2 S BH

  • Multiple-type clinical chemistry analyte profile IVD, control
PENTOBARBITAL LEVEL 1
UTAK LABORATORIES, INC.
PENTO 1 V2 S BH
In Commercial Distribution

  • B800PENTO1V2SBH5 ()
  • B800PENTO1V2SBH0 ()

  • Total Volume: 5 Milliliter
PENTO 1 V2 S BH

  • 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
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
MD LABS 43 DRUGS LOW
UTAK LABORATORIES, INC.
MD LABS 43 V2 LOW
In Commercial Distribution

  • B800MDLABS43V2LOW5 ()
  • B800MDLABS43V2LOW0 ()

  • Total Volume: 1 Milliliter
MD LABS 43 V2 LOW

  • Multiple-type clinical chemistry analyte profile IVD, control
MD LABS 43 DRUGS HIGH
UTAK LABORATORIES, INC.
MD LABS 43 V2 HIGH
In Commercial Distribution

  • B800MDLABS43V2HIGH0 ()

  • Total Volume: 1 Milliliter
MD LABS 43 V2 HIGH

  • Multiple-type clinical chemistry analyte profile IVD, control
FENTANYL PLUS LEVEL 4
UTAK LABORATORIES, INC.
FENT+ 4 V2 U NJSP
In Commercial Distribution

  • B800FENT4V2UNJSP5 ()
  • B800FENT4V2UNJSP0 ()

  • Total Volume: 5 Microliter
FENT+ 4 V2 U NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control
FENTANYL PLUS LEVEL 3
UTAK LABORATORIES, INC.
FENT+ 3 V2 U NJSP
In Commercial Distribution

  • B800FENT3V2UNJSP5 ()
  • B800FENT3V2UNJSP0 ()

  • Total Volume: 5 Microliter
FENT+ 3 V2 U NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control
FENTANYL PLUS LEVEL 2
UTAK LABORATORIES, INC.
FENT+ 2 V2 U NJSP
In Commercial Distribution

  • B800FENT2V2UNJSP5 ()
  • B800FENT2V2UNJSP0 ()

  • Total Volume: 5 Milliliter
FENT+ 2 V2 U NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control
FENTANYL PLUS LEVEL 1
UTAK LABORATORIES, INC.
FENT+ 1 V2 U NJSP
In Commercial Distribution

  • B800FENT1V2UNJSP5 ()
  • B800FENT1V2UNJSP0 ()

  • Total Volume: 5 Milliliter
FENT+ 1 V2 U NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control
ETHANOL 50 MG/DL
UTAK LABORATORIES, INC.
ETH 50 V2 U UMMC
In Commercial Distribution

  • B800ETH50V2UUMMC5 ()
  • B800ETH50V2UUMMC0 ()

  • Total Volume: 5 Milliliter
ETH 50 V2 U UMMC

  • Multiple-type clinical chemistry analyte profile IVD, control
AXIS VOL QC #4
UTAK LABORATORIES, INC.
ETH 350 V2 W AIT
In Commercial Distribution

  • B800ETH350V2WAIT5 ()
  • B800ETH350V2WAIT0 ()

  • Total Volume: 5 Milliliter
ETH 350 V2 W AIT

  • Multiple-type clinical chemistry analyte profile IVD, control
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