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 QC A LEVEL 2
UTAK LABORATORIES, INC.
QC A2 OF F WHPM
In Commercial Distribution

  • B800QCA2OFFWHPM5 ()
  • B800QCA2OFFWHPM0 ()

  • Total Volume: 3 Milliliter
QC A2 OF F WHPM

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE QC A LEVEL 1
UTAK LABORATORIES, INC.
QC A1 OF F WHPM
In Commercial Distribution

  • B800QCA1OFFWHPM5 ()
  • B800QCA1OFFWHPM0 ()

  • Total Volume: 3 Milliliter
QC A1 OF F WHPM

  • Multiple-type clinical chemistry analyte profile IVD, control
QUALITY CONTROL 3
UTAK LABORATORIES, INC.
QC 3 U F OSUMC
In Commercial Distribution

  • B800QC3UFOSUMC5 ()
  • B800QC3UFOSUMC0 ()

  • Total Volume: 10 Milliliter
QC 3 U F OSUMC

  • Multiple drugs of abuse IVD, control
QUALITY CONTROL 2
UTAK LABORATORIES, INC.
QC 2 U F OSUMC
In Commercial Distribution

  • B800QC2UFOSUMC5 ()
  • B800QC2UFOSUMC0 ()

  • Total Volume: 10 Milliliter
QC 2 U F OSUMC

  • Multiple drugs of abuse IVD, control
QUALITY CONTROL 1
UTAK LABORATORIES, INC.
QC 1 U F OSUMC
In Commercial Distribution

  • B800QC1UFOSUMC5 ()
  • B800QC1UFOSUMC0 ()

  • Total Volume: 10 Milliliter
QC 1 U F OSUMC

  • Multiple drugs of abuse IVD, control
P/Z QC V12 LOW
UTAK LABORATORIES, INC.
P/Z QC V12 L U F ML
In Commercial Distribution

  • B800PZQCV12LUFML5 ()
  • B800PZQCV12LUFML0 ()

  • Total Volume: 17 Milliliter
P/Z QC V12 L U F ML

  • Multiple therapeutic drugs/drugs of abuse IVD, control
P/Z QC V12 HIGH
UTAK LABORATORIES, INC.
P/Z QC V12 H U F ML
In Commercial Distribution

  • B800PZQCV12HUFML5 ()
  • B800PZQCV12HUFML0 ()

  • Total Volume: 17 Milliliter
P/Z QC V12 H U F ML

  • Multiple therapeutic drugs/drugs of abuse IVD, control
P/Z CALIBRATOR V12
UTAK LABORATORIES, INC.
P/Z CAL V12 U F ML
In Commercial Distribution

  • B800PZCALV12UFML5 ()
  • B800PZCALV12UFML0 ()

  • Total Volume: 26 Milliliter
P/Z CAL V12 U F ML

  • Multiple therapeutic drugs/drugs of abuse IVD, control
PTZH C3
UTAK LABORATORIES, INC.
PTZH L3 MAYO
In Commercial Distribution

  • B800PTZHL3MAYO5 ()
  • B800PTZHL3MAYO0 ()

  • Total Volume: 0.75 Milliliter
PTZH L3 MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
PTZH C2
UTAK LABORATORIES, INC.
PTZH L2 MAYO
In Commercial Distribution

  • B800PTZHL2MAYO5 ()
  • B800PTZHL2MAYO0 ()

  • Total Volume: 0.75 Milliliter
PTZH L2 MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
PTZH C1
UTAK LABORATORIES, INC.
PTZH L1 MAYO
In Commercial Distribution

  • B800PTZHL1MAYO5 ()
  • B800PTZHL1MAYO0 ()

  • Total Volume: 0.75 Milliliter
PTZH L1 MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
PT SAMPLE 2019 V2
UTAK LABORATORIES, INC.
PT 2019 UTAK V2
In Commercial Distribution

  • B800PT2019UTAKV25 ()
  • B800PT2019UTAKV20 ()

  • Total Volume: 25 Milliliter
PT 2019 UTAK V2

  • Multiple-type clinical chemistry analyte profile IVD, control
PSYCH URINE V5 CALIBRATOR
UTAK LABORATORIES, INC.
PSY UR V5 CAL
In Commercial Distribution

  • B800PSYURV5CAL5 ()
  • B800PSYURV5CAL0 ()

  • Total Volume: 6 Milliliter
PSY UR V5 CAL

  • Multiple therapeutic drugs/drugs of abuse IVD, control
PSYCH URINE V3 CALIBRATOR
UTAK LABORATORIES, INC.
PSY UR V3 CAL
In Commercial Distribution

  • B800PSYURV3CAL5 ()
  • B800PSYURV3CAL0 ()

  • Total Volume: 8 Milliliter
PSY UR V3 CAL

  • Multiple-type clinical chemistry analyte profile IVD, control
PSYCH QC 4 V4
UTAK LABORATORIES, INC.
PSYCH QC 4 V4 U F
In Commercial Distribution

  • B800PSYCHQC4V4UF5 ()
  • B800PSYCHQC4V4UF0 ()

  • Total Volume: 3 Milliliter
PSYCH QC 4 V4 U F

  • Multiple therapeutic drugs/drugs of abuse IVD, control
PSYCH QC 4 V3
UTAK LABORATORIES, INC.
PSYCH QC 4 V3 U F
In Commercial Distribution

  • B800PSYCHQC4V3UF5 ()
  • B800PSYCHQC4V3UF0 ()

  • Total Volume: 5 Milliliter
PSYCH QC 4 V3 U F

  • Multiple therapeutic drugs/drugs of abuse IVD, control
PSYCH QC 3 V4
UTAK LABORATORIES, INC.
PSYCH QC 3 V4 U F
In Commercial Distribution

  • B800PSYCHQC3V4UF5 ()
  • B800PSYCHQC3V4UF0 ()

  • Total Volume: 3 Milliliter
PSYCH QC 3 V4 U F

  • Multiple therapeutic drugs/drugs of abuse IVD, control
PSYCH QC 3 V3
UTAK LABORATORIES, INC.
PSYCH QC 3 V3 U F
In Commercial Distribution

  • B800PSYCHQC3V3UF5 ()
  • B800PSYCHQC3V3UF0 ()

  • Total Volume: 5 Milliliter
PSYCH QC 3 V3 U F

  • Multiple therapeutic drugs/drugs of abuse IVD, control
PSYCH PANEL LEVEL 2
UTAK LABORATORIES, INC.
PSYCH 2 F M ACL
In Commercial Distribution

  • B800PSYCH2FMACL5 ()
  • B800PSYCH2FMACL0 ()

  • Total Volume: 3 Milliliter
PSYCH 2 F M ACL

  • Multiple-type clinical chemistry analyte profile IVD, control
PSYCH PANEL LEVEL 1
UTAK LABORATORIES, INC.
PSYCH 1 F M ACL
In Commercial Distribution

  • B800PSYCH1FMACL5 ()
  • B800PSYCH1FMACL0 ()

  • Total Volume: 3 Milliliter
PSYCH 1 F M ACL

  • Multiple-type clinical chemistry analyte profile IVD, control
TOTAL PSA 400 NG/ML
UTAK LABORATORIES, INC.
PSA 400 S F BD
In Commercial Distribution

  • B800PSA400SFBD5 ()
  • B800PSA400SFBD0 ()

  • Total Volume: 10 Milliliter
PSA 400 S F BD

  • Multiple-type clinical chemistry analyte profile IVD, control
PREGNENOLONE PLUS
UTAK LABORATORIES, INC.
REGN+ SMX S F PC
In Commercial Distribution

  • B800PREGNSMXSFPC5 ()
  • B800PREGNSMXSFPC0 ()

  • Total Volume: 5 Milliliter
REGN+ SMX S F PC

  • Multiple-type clinical chemistry analyte profile IVD, control
PREGNENOLONE LEVEL 3
UTAK LABORATORIES, INC.
PREGN 3 S F BRL
In Commercial Distribution

  • B800PREGN3SFBRL5 ()
  • B800PREGN3SFBRL0 ()

  • Total Volume: 5 Milliliter
PREGN 3 S F BRL

  • Multiple-type clinical chemistry analyte profile IVD, control
PREGNENOLONE LEVEL 2
UTAK LABORATORIES, INC.
PREGN 2 S F BRL
In Commercial Distribution

  • B800PREGN2SFBRL5 ()
  • B800PREGN2SFBRL0 ()

  • Total Volume: 5 Milliliter
PREGN 2 S F BRL

  • Multiple-type clinical chemistry analyte profile IVD, control
PREGNENOLONE LEVEL 1
UTAK LABORATORIES, INC.
PREGN 1 S F BRL
In Commercial Distribution

  • B800PREGN1SFBRL5 ()
  • B800PREGN1SFBRL0 ()

  • Total Volume: 5 Milliliter
PREGN 1 S F BRL

  • Multiple-type clinical chemistry analyte profile IVD, control
POSITIVE WHOLE BLOOD
UTAK LABORATORIES, INC.
POS WB F TDPS
In Commercial Distribution

  • B800POSWBFTDPS0 ()

  • Total Volume: 250 Milliliter
POS WB F TDPS

  • Multiple drugs of abuse IVD, control
Positive Whole Blood
UTAK LABORATORIES, INC.
POS WB F SP
In Commercial Distribution

  • B800POSWBFSP5 ()
  • B800POSWBFSP0 ()

  • Total Volume: 250 Milliliter
POS WB F SP

  • Multiple-type clinical chemistry analyte profile IVD, control
POSITIVE WHOLE BLOOD
UTAK LABORATORIES, INC.
POS WB F JH
In Commercial Distribution

  • B800POSWBFJH5 ()
  • B800POSWBFJH0 ()

  • Total Volume: 250 Milliliter
POS WB F JH

  • Multiple-type clinical chemistry analyte profile IVD, control
POSITIVE WHOLE BLOOD
UTAK LABORATORIES, INC.
POS WB 250 OT
In Commercial Distribution

  • B800POSWB250OT5 ()
  • B800POSWB250OT0 ()

  • Total Volume: 250 Milliliter
POS WB 250 OT

  • Multiple-type clinical chemistry analyte profile IVD, control
POSITIVE
UTAK LABORATORIES, INC.
POS S F BD
In Commercial Distribution

  • B800POSSFBD5 ()
  • B800POSSFBD0 ()

  • Total Volume: 1 Milliliter
POS S F BD

  • Multiple-type clinical chemistry analyte profile IVD, control
POSITIVE PLASMA
UTAK LABORATORIES, INC.
POS P F MSKCC
In Commercial Distribution

  • B800POSPFMSKCC5 ()
  • B800POSPFMSKCC0 ()

  • Total Volume: 500 Milliliter
POS P F MSKCC

  • Multiple-type clinical chemistry analyte profile IVD, control
POSITIVE DEFIBRINATED PLASMA
UTAK LABORATORIES, INC.
POS P F LSA
In Commercial Distribution

  • B800POSPFLSA5 ()
  • B800POSPFLSA0 ()

  • Total Volume: 500 Milliliter
POS P F LSA

  • Multiple-type clinical chemistry analyte profile IVD, control
POSITIVE CONTROL
UTAK LABORATORIES, INC.
POS CON 50 WB F EBS
In Commercial Distribution

  • B800POSCON50WBFEBS5 ()
  • B800POSCON50WBFEBS0 ()

  • Total Volume: 3 Milliliter
POS CON 50 WB F EBS

  • Multiple-type clinical chemistry analyte profile IVD, control
PETH LEVEL 7 V2
UTAK LABORATORIES, INC.
PETH 7 V2 WB F HFHS
In Commercial Distribution

  • B800PETH7V2WBFHFHS5 ()
  • B800PETH7V2WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 7 V2 WB F HFHS

  • Multiple drugs of abuse IVD, control
PETH LEVEL 5 V2
UTAK LABORATORIES, INC.
PETH 5 V2 WB F HFHS
In Commercial Distribution

  • B800PETH5V2WBFHFHS5 ()
  • B800PETH5V2WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 5 V2 WB F HFHS

  • Multiple drugs of abuse IVD, control
PETH LEVEL 3
UTAK LABORATORIES, INC.
PETH 3 WB F HFHS
In Commercial Distribution

  • B800PETH3WBFHFHS5 ()
  • B800PETH3WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 3 WB F HFHS

  • Multiple drugs of abuse IVD, control
PETH LEVEL 3
UTAK LABORATORIES, INC.
PETH 3 V3 WB F MAYO
In Commercial Distribution

  • B800PETH3V3WBFMAYO5 ()
  • B800PETH3V3WBFMAYO0 ()

  • Total Volume: 1 Milliliter
PETH 3 V3 WB F MAYO

  • Multiple-type clinical chemistry analyte profile 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
PETH LEVEL 3 V2
UTAK LABORATORIES, INC.
PETH 3 V2 WB F HFHS
In Commercial Distribution

  • B800PETH3V2WBFHFHS5 ()
  • B800PETH3V2WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 3 V2 WB F HFHS

  • Multiple drugs of abuse IVD, control
PETH LEVEL 3
UTAK LABORATORIES, INC.
PETH 3 K2WB F UM
In Commercial Distribution

  • B800PETH3K2WBFUM5 ()
  • B800PETH3K2WBFUM0 ()

  • Total Volume: 1 Milliliter
PETH 3 K2WB F UM

  • Multiple drugs of abuse IVD, control
PETH LEVEL 2
UTAK LABORATORIES, INC.
PETH 2 WB F UCSD
In Commercial Distribution

  • B800PETH2WBFUCSD0 ()
  • B800PETH2WBFUCSD5 ()

  • Total Volume: 1 Milliliter
PETH 2 WB F UCSD

  • Multiple-type clinical chemistry analyte profile IVD, control
PETH LEVEL 2
UTAK LABORATORIES, INC.
PETH 2 WB F HFHS
In Commercial Distribution

  • B800PETH2WBFHFHS5 ()
  • B800PETH2WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 2 WB F HFHS

  • Multiple drugs of abuse IVD, control
PETH LEVEL 2 V2
UTAK LABORATORIES, INC.
PETH 2 V2 WB F HFHS
In Commercial Distribution

  • B800PETH2V2WBFHFHS5 ()
  • B800PETH2V2WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 2 V2 WB F HFHS

  • Multiple drugs of abuse IVD, control
PETH LEVEL 2
UTAK LABORATORIES, INC.
PETH 2 K2WB F UM
In Commercial Distribution

  • B800PETH2K2WBFUM5 ()
  • B800PETH2K2WBFUM0 ()

  • Total Volume: 1 Milliliter
PETH 2 K2WB F UM

  • Multiple drugs of abuse IVD, control
PETH LEVEL 1
UTAK LABORATORIES, INC.
PETH 1 WB F HFHS
In Commercial Distribution

  • B800PETH1WBFHFHS5 ()
  • B800PETH1WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 1 WB F HFHS

  • Multiple drugs of abuse IVD, control
PETH LEVEL 1 V2
UTAK LABORATORIES, INC.
PETH 1 V2 WB F HFHS
In Commercial Distribution

  • B800PETH1V2WBFHFHS5 ()
  • B800PETH1V2WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 1 V2 WB F HFHS

  • Multiple drugs of abuse IVD, control
PETH LEVEL 1
UTAK LABORATORIES, INC.
PETH 1 K2WB F UM
In Commercial Distribution

  • B800PETH1K2WBFUM5 ()
  • B800PETH1K2WBFUM0 ()

  • Total Volume: 1 Milliliter
PETH 1 K2WB F UM

  • Multiple drugs of abuse IVD, control
OPIATES PLUS
UTAK LABORATORIES, INC.
OPIA+ WB WC
In Commercial Distribution

  • B800OPIAWBWC5 ()
  • B800OPIAWBWC0 ()

  • Total Volume: 5 Milliliter
OPIA+ WB WC

  • Multiple therapeutic drugs/drugs of abuse IVD, control
OPIATES MID
UTAK LABORATORIES, INC.
OPIA MID U UNC
In Commercial Distribution

  • B800OPIAMIDUUNC5 ()
  • B800OPIAMIDUUNC0 ()

  • Total Volume: 2 Milliliter
OPIA MID U UNC

  • Multiple-type clinical chemistry analyte profile IVD, control
OPIATES LOW
UTAK LABORATORIES, INC.
OPIA LOW U UNC
In Commercial Distribution

  • B800OPIALOWUUNC5 ()
  • B800OPIALOWUUNC0 ()

  • Total Volume: 2 Milliliter
OPIA LOW U UNC

  • Multiple-type clinical chemistry analyte profile IVD, control
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