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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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URINE QC LOW - B80001390500030

No Description
UTAK LABORATORIES, INC.
U QC LOW V2 EL
In Commercial Distribution

  • B80001390500030 ()
  • B80001390500031 ()
  • B80001390500032 ()
  • B80001390500033 ()
  • B80001390500036 ()
  • B80001390500037 ()
  • B80001390500038 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

VORICONAZOLE PLUS LEVEL 3 - B800VORI3V2SCMCD0

VORICONAZOLE PLUS LEVEL 3
UTAK LABORATORIES, INC.
VORI+ 3 V2 S CMCD
In Commercial Distribution

  • B800VORI3V2SCMCD0 ()

  • Total Volume: 3 Milliliter
VORI+ 3 V2 S CMCD

  • Multiple-type clinical chemistry analyte profile IVD, control

VORICONAZOLE PLUS LEVEL 2 - B800VORI2V2SCMCD0

VORICONAZOLE PLUS LEVEL 2
UTAK LABORATORIES, INC.
VORI+ 2 V2 S CMCD
In Commercial Distribution

  • B800VORI2V2SCMCD5 ()
  • B800VORI2V2SCMCD0 ()

  • Total Volume: 3 Milliliter
VORI+ 2 V2 S CMCD

  • Multiple-type clinical chemistry analyte profile IVD, control

VORICONAZOLE PLUS LEVEL 1 - B800VORI1V2SCMCD0

VORICONAZOLE PLUS LEVEL 1
UTAK LABORATORIES, INC.
VORI+ 1 V2 S CMCD
In Commercial Distribution

  • B800VORI1V2SCMCD5 ()
  • B800VORI1V2SCMCD0 ()

  • Total Volume: 3 Milliliter
VORI+ 1 V2 S CMCD

  • Multiple-type clinical chemistry analyte profile IVD, control

VOLATILES 0.1 G/DL - B800VOLWBV2FFCL0

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

VOLATILES LEVEL 2 - B800VOL2V2SMAYO0

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 - B800VOL1V2SMAYO0

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

THC PLUS LEVEL 2 - B800THC2V2WBNJSP0

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 - B800THC2V2UNJSP0

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 - B800THC1V2WBNJSP0

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 - B800THC1V2UNJSP0

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

PENTOBARBITAL LEVEL 2 - B800PENTO2V2SBH0

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 - B800PENTO1V2SBH0

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

MD LABS 43 DRUGS LOW - B800MDLABS43V2LOW0

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 - B800MDLABS43V2HIGH0

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 - B800FENT4V2UNJSP0

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 - B800FENT3V2UNJSP0

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 - B800FENT2V2UNJSP0

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 - B800FENT1V2UNJSP0

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 - B800ETH50V2UUMMC0

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

ETGCALV2MLB - B800ETGCALV2MLB0

ETGCALV2MLB
UTAK LABORATORIES, INC.
ETG CAL V2 M LB
In Commercial Distribution

  • B800ETGCALV2MLB5 ()
  • B800ETGCALV2MLB0 ()

  • Total Volume: 0.5 Milliliter
ETG CAL V2 M LB

  • Multiple-type clinical chemistry analyte profile IVD, control

DRUGS OF ABUSE 3 - B800DAWB3V2OCME0

DRUGS OF ABUSE 3
UTAK LABORATORIES, INC.
DA WB 3 V2 OCME
In Commercial Distribution

  • B800DAWB3V2OCME5 ()
  • B800DAWB3V2OCME0 ()

  • Total Volume: 10 Milliliter
DA WB 3 V2 OCME

  • Multiple-type clinical chemistry analyte profile IVD, control

DRUGS OF ABUSE - B800DAWB2PTV2SDHL0

DRUGS OF ABUSE
UTAK LABORATORIES, INC.
DA WB 2PT V2 SDHL
In Commercial Distribution

  • B800DAWB2PTV2SDHL5 ()
  • B800DAWB2PTV2SDHL0 ()

  • Total Volume: 2 Milliliter
DA WB 2PT V2 SDHL

  • Multiple-type clinical chemistry analyte profile IVD, control

DAU LOW - B800DAUV2LQCSH0

DAU LOW
UTAK LABORATORIES, INC.
DAU V2 L QC SH
In Commercial Distribution

  • B800DAUV2LQCSH5 ()
  • B800DAUV2LQCSH0 ()

  • Total Volume: 3 Milliliter
DAU V2 L QC SH

  • Multiple drugs of abuse IVD, control

DAU NEGATIVE - B800DAUNEGV2FCH0

DAU NEGATIVE
UTAK LABORATORIES, INC.
DAU NEG V2 F CH
In Commercial Distribution

  • B800DAUNEGV2FCH5 ()
  • B800DAUNEGV2FCH0 ()

  • Total Volume: 10 Milliliter
DAU NEG V2 F CH

  • Multiple-type clinical chemistry analyte profile IVD, control

DRUGS OF ABUSE MID - B800DAUMV2FUPHS0

DRUGS OF ABUSE MID
UTAK LABORATORIES, INC.
DAU M V2 F UPHS
In Commercial Distribution

  • B800DAUMV2FUPHS5 ()
  • B800DAUMV2FUPHS0 ()

  • Total Volume: 2 Milliliter
DAU M V2 F UPHS

  • Multiple-type clinical chemistry analyte profile IVD, control

DRUGS OF ABUSE HIGH - B800DAUHV2FUPHS0

DRUGS OF ABUSE HIGH
UTAK LABORATORIES, INC.
DAU H V2 F UPHS
In Commercial Distribution

  • B800DAUHV2FUPHS5 ()
  • B800DAUHV2FUPHS0 ()

  • Total Volume: 2 Milliliter
DAU H V2 F UPHS

  • Multiple-type clinical chemistry analyte profile IVD, control

DRUGS OF ABUSE HIGH - B800DAUHV2FMAYO0

DRUGS OF ABUSE HIGH
UTAK LABORATORIES, INC.
DAU H V2 F MAYO
In Commercial Distribution

  • B800DAUHV2FMAYO5 ()
  • B800DAUHV2FMAYO0 ()

  • Total Volume: 25 Milliliter
DAU H V2 F MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control

DRUGS OF ABUSE SCREENING LEVEL 2 - B800DAU2V2IAQC0

DRUGS OF ABUSE SCREENING LEVEL 2
UTAK LABORATORIES, INC.
DAU 2 V2 IA QC
In Commercial Distribution

  • B800DAU2V2IAQC5 ()
  • B800DAU2V2IAQC0 ()

  • Total Volume: 20 Milliliter
DAU 2 V2 IA QC

  • Multiple-type clinical chemistry analyte profile IVD, control

DRUGS OF ABUSE LEVEL 2 - B800DAU2V2FAPS0

DRUGS OF ABUSE LEVEL 2
UTAK LABORATORIES, INC.
DAU 2 V2 F APS
In Commercial Distribution

  • B800DAU2V2FAPS5 ()
  • B800DAU2V2FAPS0 ()

  • Total Volume: 10 Milliliter
DAU 2 V2 F APS

  • Multiple drugs of abuse IVD, control
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