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 SCREEN NEGATIVE
UTAK LABORATORIES, INC.
DAU NEG F QC VU
In Commercial Distribution

  • B800DAUNEGFQCVU5 ()
  • B800DAUNEGFQCVU0 ()

  • Total Volume: 7.5 Milliliter
DAU NEG F QC VU

  • Multiple therapeutic drugs/drugs of abuse IVD, control
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
DAU MID QC
UTAK LABORATORIES, INC.
DAU M QC V3 F UHCMC
In Commercial Distribution

  • B800DAUMQCV3FUHCMC5 ()
  • B800DAUMQCV3FUHCMC0 ()

  • Total Volume: 0.8 Milliliter
DAU M QC V3 F UHCMC

  • Multiple-type clinical chemistry analyte profile IVD, control
DAUMIDV4F2PTTL
UTAK LABORATORIES, INC.
DAU MID V4 F 2PT TL
In Commercial Distribution

  • B800DAUMIDV4F2PTTL5 ()
  • B800DAUMIDV4F2PTTL0 ()

  • Total Volume: 0.45 Milliliter
DAU MID V4 F 2PT TL

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

  • B800DAUMIDV2FPG5 ()
  • B800DAUMIDV2FPG0 ()

  • Total Volume: 2 Milliliter
DAU MID V2 F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE MID
UTAK LABORATORIES, INC.
DAU MID F PG
In Commercial Distribution

  • B800DAUMIDFPG5 ()
  • B800DAUMIDFPG0 ()

  • Total Volume: 2 Milliliter
DAU MID F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU MID
UTAK LABORATORIES, INC.
DAU MID ABS
In Commercial Distribution

  • B800DAUMIDABS0 ()

  • Total Volume: 2 Milliliter
DAU MID ABS

  • Multiple therapeutic drugs/drugs of abuse IVD, control
DRUGS OF ABUSE LOW
UTAK LABORATORIES, INC.
DAU L V2 F UPHS
In Commercial Distribution

  • B800DAULV2FUPHS5 ()
  • B800DAULV2FUPHS0 ()

  • Total Volume: 2 Milliliter
DAU L V2 F UPHS

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

  • B800DAULV2FMAYO5 ()
  • B800DAULV2FMAYO0 ()

  • Total Volume: 25 Milliliter
DAU L V2 F MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU LOW QC
UTAK LABORATORIES, INC.
DAU L QC V3 F UHCMC
In Commercial Distribution

  • B800DAULQCV3FUHCMC5 ()
  • B800DAULQCV3FUHCMC0 ()

  • Total Volume: 0.8 Milliliter
DAU L QC V3 F UHCMC

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU LOW QC
UTAK LABORATORIES, INC.
DAU L QC F SH
In Commercial Distribution

  • B800DAULQCFSH5 ()
  • B800DAULQCFSH0 ()

  • Total Volume: 3 Milliliter
DAU L QC F SH

  • Multiple-type clinical chemistry analyte profile IVD, control
DAULOWV4F2PTTL
UTAK LABORATORIES, INC.
DAU LOW V4 F 2PT TL
In Commercial Distribution

  • B800DAULOWV4F2PTTL5 ()
  • B800DAULOWV4F2PTTL0 ()

  • Total Volume: 0.45 Milliliter
DAU LOW V4 F 2PT TL

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

  • B800DAULOWV2FPG5 ()
  • B800DAULOWV2FPG0 ()

  • Total Volume: 2 Milliliter
DAU LOW V2 F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LOW
UTAK LABORATORIES, INC.
DAU LOW F PG
In Commercial Distribution

  • B800DAULOWFPG5 ()
  • B800DAULOWFPG0 ()

  • Total Volume: 2 Milliliter
DAU LOW F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU LOW
UTAK LABORATORIES, INC.
DAU LOW ABS
In Commercial Distribution

  • B800DAULOWABS0 ()

  • Total Volume: 2 Milliliter
DAU LOW ABS

  • Multiple therapeutic drugs/drugs of abuse IVD, control
DRUGS OF ABUSE CAL LEVEL 2
UTAK LABORATORIES, INC.
DAU+ L LEVEL 2 V3 URMC
In Commercial Distribution

  • B800DAULLEVEL2V3URMC5 ()
  • B800DAULLEVEL2V3URMC0 ()

  • Total Volume: 5 Milliliter
DAU+ L LEVEL 2 V3 URMC

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE CAL LEVEL 1
UTAK LABORATORIES, INC.
DAU+ L LEVEL 1 V3 URMC
In Commercial Distribution

  • B800DAULLEVEL1V3URMC5 ()
  • B800DAULLEVEL1V3URMC0 ()

  • Total Volume: 5 Milliliter
DAU+ L LEVEL 1 V3 URMC

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU LOW
UTAK LABORATORIES, INC.
DAU L F YNHH
In Commercial Distribution

  • B800DAULFYNHH5 ()
  • B800DAULFYNHH0 ()

  • Total Volume: 2.6 Milliliter
DAU L F YNHH

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU LOW
UTAK LABORATORIES, INC.
DAU L F TQHS
In Commercial Distribution

  • B800DAULFTQHS5 ()
  • B800DAULFTQHS0 ()

  • Total Volume: 25 Milliliter
DAU L F TQHS

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LOW
UTAK LABORATORIES, INC.
DAU L F MAYO
In Commercial Distribution

  • B800DAULFMAYO5 ()
  • B800DAULFMAYO0 ()

  • Total Volume: 50 Milliliter
DAU L F MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LEVEL 2
UTAK LABORATORIES, INC.
DAU L2 U F VMCI
In Commercial Distribution

  • B800DAUL2UFVMCI5 ()
  • B800DAUL2UFVMCI0 ()

  • Total Volume: 1 Milliliter
DAU L2 U F VMCI

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE LEVEL 2
UTAK LABORATORIES, INC.
DAU L2 F KA
In Commercial Distribution

  • B800DAUL2FKA5 ()
  • B800DAUL2FKA0 ()

  • Total Volume: 5 Milliliter
DAU L2 F KA

  • Multiple therapeutic drugs/drugs of abuse IVD, control
DRUGS OF ABUSE LEVEL 1
UTAK LABORATORIES, INC.
DAU L1 U F VMCI
In Commercial Distribution

  • B800DAUL1UFVMCI5 ()
  • B800DAUL1UFVMCI0 ()

  • Total Volume: 1 Milliliter
DAU L1 U F VMCI

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE LEVEL 1
UTAK LABORATORIES, INC.
DAU L1 F KA
In Commercial Distribution

  • B800DAUL1FKA5 ()
  • B800DAUL1FKA0 ()

  • Total Volume: 5 Milliliter
DAU L1 F KA

  • Multiple therapeutic drugs/drugs of abuse IVD, control
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
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
DAU HIGH QC
UTAK LABORATORIES, INC.
DAU H QC V3 F UHCMC
In Commercial Distribution

  • B800DAUHQCV3FUHCMC5 ()
  • B800DAUHQCV3FUHCMC0 ()

  • Total Volume: 0.8 Milliliter
DAU H QC V3 F UHCMC

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU HIGH QC
UTAK LABORATORIES, INC.
DAU H QC F SH
In Commercial Distribution

  • B800DAUHQCFSH5 ()
  • B800DAUHQCFSH0 ()

  • Total Volume: 3 Milliliter
DAU H QC F SH

  • Multiple-type clinical chemistry analyte profile IVD, control
DAUHIGHV4F2PTTL
UTAK LABORATORIES, INC.
DAU HIGH V4 F 2PT TL
In Commercial Distribution

  • B800DAUHIGHV4F2PTTL5 ()
  • B800DAUHIGHV4F2PTTL0 ()

  • Total Volume: 0.45 Milliliter
DAU HIGH V4 F 2PT TL

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

  • B800DAUHIGHV2FPG5 ()
  • B800DAUHIGHV2FPG0 ()

  • Total Volume: 2 Milliliter
DAU HIGH V2 F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE HIGH
UTAK LABORATORIES, INC.
DAU HIGH F PG
In Commercial Distribution

  • B800DAUHIGHFPG5 ()
  • B800DAUHIGHFPG0 ()

  • Total Volume: 2 Milliliter
DAU HIGH F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU HIGH
UTAK LABORATORIES, INC.
DAU HIGH ABS
In Commercial Distribution

  • B800DAUHIGHABS0 ()

  • Total Volume: 2 Milliliter
DAU HIGH ABS

  • Multiple therapeutic drugs/drugs of abuse IVD, control
DAU HIGH
UTAK LABORATORIES, INC.
DAU H F YNHH
In Commercial Distribution

  • B800DAUHFYNHH5 ()
  • B800DAUHFYNHH0 ()

  • Total Volume: 2.6 Milliliter
DAU H F YNHH

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU HIGH
UTAK LABORATORIES, INC.
DAU H F TQHS
In Commercial Distribution

  • B800DAUHFTQHS5 ()
  • B800DAUHFTQHS0 ()

  • Total Volume: 25 Milliliter
DAU H F TQHS

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE HIGH
UTAK LABORATORIES, INC.
DAU H F MAYO
In Commercial Distribution

  • B800DAUHFMAYO5 ()
  • B800DAUHFMAYO0 ()

  • Total Volume: 50 Milliliter
DAU H F MAYO

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

  • B800DAUFISPP5 ()
  • B800DAUFISPP0 ()

  • Total Volume: 50 Milliliter
DAU F ISPP

  • Multiple-type clinical chemistry analyte profile IVD, control
B800DAUCONT2FRX0
UTAK LABORATORIES, INC.
DAU CONT 2 F RX
In Commercial Distribution

  • B800DAUCONT2FRX5 ()
  • B800DAUCONT2FRX0 ()

  • Total Volume: 5 Milliliter
DAU CONT 2 F RX

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU CONTROL LEVEL 1
UTAK LABORATORIES, INC.
DAU CONT 1 F RX
In Commercial Distribution

  • B800DAUCONT1FRX5 ()
  • B800DAUCONT1FRX0 ()

  • Total Volume: 5 Milliliter
DAU CONT 1 F RX

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU CALIBRATOR KIT
UTAK LABORATORIES, INC.
DAU CAL KIT ABS
In Commercial Distribution

  • B800DAUCALKITABS5 ()

  • Total Volume: 2 Milliliter
DAU CAL KIT ABS

  • Multiple therapeutic drugs/drugs of abuse IVD, control
DAU CALIBRATOR 8
UTAK LABORATORIES, INC.
DAU CAL 8 F IUH
In Commercial Distribution

  • B800DAUCAL8FIUH5 ()
  • B800DAUCAL8FIUH0 ()

  • Total Volume: 0.5 Milliliter
DAU CAL 8 F IUH

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU CALIBRATOR 7
UTAK LABORATORIES, INC.
DAU CAL 7 F IUH
In Commercial Distribution

  • B800DAUCAL7FIUH5 ()
  • B800DAUCAL7FIUH0 ()

  • Total Volume: 0.5 Milliliter
DAU CAL 7 F IUH

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU CALIBRATOR LEVEL 7
UTAK LABORATORIES, INC.
DAU CAL 7 F ERSO
In Commercial Distribution

  • B800DAUCAL7FERSO5 ()
  • B800DAUCAL7FERSO0 ()

  • Total Volume: 4 Milliliter
DAU CAL 7 F ERSO

  • Multiple drugs of abuse IVD, control
DAUCAL6V5FSEMCE
UTAK LABORATORIES, INC.
DAU CAL 6 V5 F SEMCE
In Commercial Distribution

  • B800DAUCAL6V5FSEMCE5 ()
  • B800DAUCAL6V5FSEMCE0 ()

  • Total Volume: 2 Milliliter
DAU CAL 6 V5 F SEMCE

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LEVEL 6
UTAK LABORATORIES, INC.
DAU CAL 6 V3 F NHI
In Commercial Distribution

  • B800DAUCAL6V3FNHI5 ()
  • B800DAUCAL6V3FNHI0 ()

  • Total Volume: 1 Milliliter
DAU CAL 6 V3 F NHI

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE CALIBRATOR 6
UTAK LABORATORIES, INC.
DAU CAL 6 U F NPIL
In Commercial Distribution

  • B800DAUCAL6UFNPIL5 ()
  • B800DAUCAL6UFNPIL0 ()

  • Total Volume: 2 Milliliter
DAU CAL 6 U F NPIL

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU CALIBRATOR 6
UTAK LABORATORIES, INC.
DAU CAL 6 F IUH
In Commercial Distribution

  • B800DAUCAL6FIUH5 ()
  • B800DAUCAL6FIUH0 ()

  • Total Volume: 0.5 Milliliter
DAU CAL 6 F IUH

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU CALIBRATOR LEVEL 6
UTAK LABORATORIES, INC.
DAU CAL 6 F ERSO
In Commercial Distribution

  • B800DAUCAL6FERSO5 ()
  • B800DAUCAL6FERSO0 ()

  • Total Volume: 4 Milliliter
DAU CAL 6 F ERSO

  • Multiple drugs of abuse IVD, control
DAUCAL5V5FSEMCE
UTAK LABORATORIES, INC.
DAU CAL 5 V5 F SEMCE
In Commercial Distribution

  • B800DAUCAL5V5FSEMCE5 ()
  • B800DAUCAL5V5FSEMCE0 ()

  • Total Volume: 2 Milliliter
DAU CAL 5 V5 F SEMCE

  • Multiple-type clinical chemistry analyte profile IVD, control
DAUCAL5V4F2PTTL
UTAK LABORATORIES, INC.
DAU CAL 5 V4 F 2PT TL
In Commercial Distribution

  • B800DAUCAL5V4F2PTTL5 ()
  • B800DAUCAL5V4F2PTTL0 ()

  • Total Volume: 0.45 Milliliter
DAU CAL 5 V4 F 2PT TL

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LEVEL 5
UTAK LABORATORIES, INC.
DAU CAL 5 V3 F NHI
In Commercial Distribution

  • B800DAUCAL5V3FNHI5 ()
  • B800DAUCAL5V3FNHI0 ()

  • Total Volume: 1 Milliliter
DAU CAL 5 V3 F NHI

  • Multiple drugs of abuse IVD, control
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