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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DRUGS OF ABUSE LEVEL 3
UTAK LABORATORIES, INC.
DAU 3 V2 F U VMG
In Commercial Distribution

  • B800DAU3V2FUVMG0 ()
  • B800DAU3V2FUVMG05 ()
  • B800DAU3V2FUVMG5 ()

  • Total Volume: 10 Milliliter
DAU 3 V2 F U VMG

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE LEVEL 2
UTAK LABORATORIES, INC.
DAU 2 V2 F U VMG
In Commercial Distribution

  • B800DAU2V2FUVMG5 ()
  • B800DAU2V2FUVMG0 ()

  • Total Volume: 10 Milliliter
DAU 2 V2 F U VMG

  • Multiple therapeutic drugs/drugs of abuse IVD, control
DRUGS OF ABUSE LEVEL 1
UTAK LABORATORIES, INC.
DAU 1 V2 F U VMG
In Commercial Distribution

  • B800DAU1V2FUVMG5 ()
  • B800DAU1V2FUVMG0 ()

  • Total Volume: 10 Milliliter
DAU 1 V2 F U VMG

  • Multiple drugs of abuse IVD, control
VORICONAZOLE PLUS 3
UTAK LABORATORIES, INC.
VOR+ 3 V2 S F UNC
In Commercial Distribution

  • B800VOR3V2SFUNC5 ()
  • B800VOR3V2SFUNC0 ()

  • Total Volume: 2 Milliliter
VOR+ 3 V2 S F UNC

  • Multiple-therapy therapeutic drug monitoring IVD, control
VORICONAZOLE PLUS 2
UTAK LABORATORIES, INC.
VOR+ 2 V2 S F UNC
In Commercial Distribution

  • B800VOR2V2SFUNC5 ()
  • B800VOR2V2SFUNC0 ()

  • Total Volume: 2 Milliliter
VOR+ 2 V2 S F UNC

  • Multiple-therapy therapeutic drug monitoring IVD, control
VORICONAZOLE PLUS 1
UTAK LABORATORIES, INC.
VOR+ 1 V2 S F UNC
In Commercial Distribution

  • B800VOR1V2SFUNC5 ()
  • B800VOR1V2SFUNC0 ()

  • Total Volume: 2 Milliliter
VOR+ 1 V2 S F UNC

  • Multiple-therapy therapeutic drug monitoring IVD, control
TESTOSTERONE 7.5 NG/DL
UTAK LABORATORIES, INC.
TESTO 7.5 V2 S F LCMS
In Commercial Distribution

  • B800TESTO75V2SFLCMS5 ()
  • B800TESTO75V2SFLCMS0 ()

  • Total Volume: 1.1 Milliliter
TESTO 7.5 V2 S F LCMS

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

  • B800VOL2V2SFRIH5 ()
  • B800VOL2V2SFRIH0 ()

  • Total Volume: 5 Milliliter
VOL 2 V2 S F RIH

  • Multiple drugs of abuse IVD, control
VOLATILES LEVEL 1
UTAK LABORATORIES, INC.
VOL 1 V2 S F RIH
In Commercial Distribution

  • B800VOL1V2SFRIH5 ()
  • B800VOL1V2SFRIH0 ()

  • Total Volume: 5 Milliliter
VOL 1 V2 S F RIH

  • Multiple drugs of abuse 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
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
LEAD LEVEL 1
UTAK LABORATORIES, INC.
LEAD 1 V2 WB V WDL
In Commercial Distribution

  • B800LEAD1V2WBVWDL5 ()
  • B800LEAD1V2WBVWDL0 ()

  • Total Volume: 15 Milliliter
LEAD 1 V2 WB V WDL

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 1
UTAK LABORATORIES, INC.
LEAD 1 V2 WB F CH
In Commercial Distribution

  • B800LEAD1V2WBFCH5 ()
  • B800LEAD1V2WBFCH0 ()

  • Total Volume: 0.5 Milliliter
LEAD 1 V2 WB F CH

  • Multiple-type clinical chemistry analyte profile IVD, control
ETHYLENE GLYCOL LEVEL 2
UTAK LABORATORIES, INC.
ETHGLY 2 V2 S F RIH
In Commercial Distribution

  • B800ETHGLY2V2SFRIH0 ()
  • B800ETHGLY2V2SFRIH5 ()

  • Total Volume: 5 Milliliter
ETHGLY 2 V2 S F RIH

  • Ethylene glycol IVD, control
DRUGS OF ABUSE QC 3
UTAK LABORATORIES, INC.
DAU QC 3 V2 F BILH
In Commercial Distribution

  • B800DAUQC3V2FBILH5 ()
  • B800DAUQC3V2FBILH0 ()

  • Total Volume: 2 Milliliter
DAU QC 3 V2 F BILH

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE QC 1
UTAK LABORATORIES, INC.
DAU QC 1 V2 F BILH
In Commercial Distribution

  • B800DAUQC1V2FBILH5 ()
  • B800DAUQC1V2FBILH0 ()

  • Total Volume: 2 Milliliter
DAU QC 1 V2 F BILH

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE POSITIVE
UTAK LABORATORIES, INC.
DAU POS V2 U F PHHC
In Commercial Distribution

  • B800DAUPOSV2UFPHHC5 ()
  • B800DAUPOSV2UFPHHC0 ()

  • Total Volume: 3 Milliliter
DAU POS V2 U F PHHC

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LOW
UTAK LABORATORIES, INC.
DA LOW V2 WB F BTL
In Commercial Distribution

  • B800DALOWV2WBFBTL5 ()
  • B800DALOWV2WBFBTL0 ()

  • Total Volume: 1 Milliliter
DA LOW V2 WB F BTL

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE HIGH
UTAK LABORATORIES, INC.
DA HIGH V2 WB F BTL
In Commercial Distribution

  • B800DAHIGHV2WBFBTL5 ()
  • B800DAHIGHV2WBFBTL0 ()

  • Total Volume: 1 Milliliter
DA HIGH V2 WB F BTL

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE CUTOFF
UTAK LABORATORIES, INC.
DA CUT V2 S F PL
In Commercial Distribution

  • B800DACUTV2SFPL5 ()
  • B800DACUTV2SFPL0 ()

  • Total Volume: 5 Milliliter
DA CUT V2 S F PL

  • Multiple-type clinical chemistry analyte profile IVD, control
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