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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SPIRITS LEVEL 3
UTAK LABORATORIES, INC.
SPIRITS 3 U F OCMEO
In Commercial Distribution

  • B800SPIRITS3UFOCMEO5 ()
  • B800SPIRITS3UFOCMEO0 ()

  • Total Volume: 5 Milliliter
SPIRITS 3 U F OCMEO

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

  • B800SPIRITS3SFOCMEO5 ()
  • B800SPIRITS3SFOCMEO0 ()

  • Total Volume: 5 Milliliter
SPIRITS 3 S F OCMEO

  • Multiple-type clinical chemistry analyte profile IVD, control
SPIRITS LEVEL 2
UTAK LABORATORIES, INC.
SPIRITS 2 U F OCMEO
In Commercial Distribution

  • B800SPIRITS2UFOCMEO5 ()
  • B800SPIRITS2UFOCMEO0 ()

  • Total Volume: 5 Milliliter
SPIRITS 2 U F OCMEO

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

  • B800SPIRITS2SFOCMEO5 ()
  • B800SPIRITS2SFOCMEO0 ()

  • Total Volume: 5 Milliliter
SPIRITS 2 S F OCMEO

  • Multiple-type clinical chemistry analyte profile IVD, control
SPIRITS LEVEL 1
UTAK LABORATORIES, INC.
SPIRITS 1 SMX-VH F OCMEO
In Commercial Distribution

  • B800SPIRITS1SMXVHFOCME0 ()
  • B800SPIRITS1SMXVHFOCME5 ()

  • Total Volume: 5 Milliliter
SPIRITS 1 SMX-VH F OCMEO

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

  • B800SPIRITS1SFOCMEO5 ()
  • B800SPIRITS1SFOCMEO0 ()

  • Total Volume: 5 Milliliter
SPIRITS 1 S F OCMEO

  • Multiple-type clinical chemistry analyte profile IVD, control
SMX WHOLE BLOOD
UTAK LABORATORIES, INC.
SMX-WB 100 F SP
In Commercial Distribution

  • B800SMXWB100FSP0 ()

  • Total Volume: 100 Milliliter
SMX-WB 100 F SP

  • Multiple-type clinical chemistry analyte profile IVD, control
SMX URINE 20 ML
UTAK LABORATORIES, INC.
SMXU 20 ML F BL
In Commercial Distribution

  • B800SMXU20MLFBL5 ()
  • B800SMXU20MLFBL0 ()

  • Total Volume: 20 Milliliter
SMXU 20 ML F BL

  • Multiple-type clinical chemistry analyte profile IVD, control
SMx URINE
UTAK LABORATORIES, INC.
SMXU 10 F UMPC
In Commercial Distribution

  • B800SMXU10FUMPC5 ()
  • B800SMXU10FUMPC0 ()

  • Total Volume: 10 Milliliter
SMXU 10 F UMPC

  • Multiple-type clinical chemistry analyte profile IVD, control
SMX SERUM
UTAK LABORATORIES, INC.
SMX-S LTR F CDC
In Commercial Distribution

  • B800SMXSLTRFCDC5 ()
  • B800SMXSLTRFCDC0 ()

  • Total Volume: 1 Liter
SMX-S LTR F CDC

  • Multiple-type clinical chemistry analyte profile IVD, control
SMX CEREBRAL SPINAL FLUID 1ML
UTAK LABORATORIES, INC.
SMX CSF F CP
In Commercial Distribution

  • B800SMXCSFFCP5 ()
  • B800SMXCSFFCP0 ()

  • Total Volume: 1 Milliliter
SMX CSF F CP

  • Multiple-type clinical chemistry analyte profile IVD, control
SMA QC
UTAK LABORATORIES, INC.
SMA QC
In Commercial Distribution

  • B800SMAQC05 ()
  • B800SMAQC0 ()

  • Total Volume: 25 Milliliter
SMA QC

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

  • B800QCUFLW5 ()
  • B800QCUFLW0 ()

  • Total Volume: 2 Milliliter
QC U F LW

  • Multiple therapeutic drugs/drugs of abuse 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
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 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 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
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 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 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 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 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 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 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
PHENCYCLIDINE 1 UG/ML
UTAK LABORATORIES, INC.
PCP 1 U KPRICH
In Commercial Distribution

  • B800PCP1UKPRICH5 ()
  • B800PCP1UKPRICH0 ()

  • Total Volume: 15 Milliliter
PCP 1 U KPRICH

  • Multiple drugs of abuse IVD, control
NORDIAZEPAM 100 NG/ML
UTAK LABORATORIES, INC.
NORDIAZ 100 U F MED
In Commercial Distribution

  • B800NORDIAZ100UFMED5 ()
  • B800NORDIAZ100UFMED0 ()

  • Total Volume: 6 Milliliter
NORDIAZ 100 U F MED

  • Multiple-type clinical chemistry analyte profile IVD, control
NICOTINE PLUS 1200 NG/ML V2
UTAK LABORATORIES, INC.
NICO+ 1200 V2 U F UWHC
In Commercial Distribution

  • B800NICO1200V2UFUWHC5 ()
  • B800NICO1200V2UFUWHC0 ()

  • Total Volume: 5 Milliliter
NICO+ 1200 V2 U F UWHC

  • Multiple-type clinical chemistry analyte profile IVD, control
NICOTINE PLUS 100 NG/ML V3
UTAK LABORATORIES, INC.
NICO+ 100 V3 U F UWHC
In Commercial Distribution

  • B800NICO100V3UFUWHC5 ()
  • B800NICO100V3UFUWHC0 ()

  • Total Volume: 5 Milliliter
NICO+ 100 V3 U F UWHC

  • Multiple-type clinical chemistry analyte profile IVD, control
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