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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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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 SERUM
UTAK LABORATORIES, INC.
SMX-S 1 F NW
In Commercial Distribution

  • B800SMXS1FNW5 ()
  • B800SMXS1FNW0 ()

  • Total Volume: 1 Milliliter
SMX-S 1 F NW

  • Multiple-type clinical chemistry analyte profile IVD, control
SMx HAIR
UTAK LABORATORIES, INC.
SMX HAIR F 1L PC
In Commercial Distribution

  • B800SMXHAIRF1LPC0 ()

  • Total Volume: 1000 Milliliter
SMX HAIR F 1L PC

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LEVEL 3
UTAK LABORATORIES, INC.
SMX-DAU 3 V2 F PG
In Commercial Distribution

  • B800SMXDAU3V2FPG5 ()
  • B800SMXDAU3V2FPG0 ()

  • Total Volume: 2 Milliliter
SMX-DAU 3 V2 F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LEVEL 2
UTAK LABORATORIES, INC.
SMX-DAU 2 V2 F PG
In Commercial Distribution

  • B800SMXDAU2V2FPG5 ()
  • B800SMXDAU2V2FPG0 ()

  • Total Volume: 2 Milliliter
SMX-DAU 2 V2 F PG

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

  • B800SMXDAU1V2FPG5 ()
  • B800SMXDAU1V2FPG0 ()

  • Total Volume: 2 Milliliter
SMX-DAU 1 V2 F PG

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

  • B800SMXCSFFMAYO5 ()
  • B800SMXCSFFMAYO0 ()

  • Total Volume: 100 Milliliter
SMX-CSF F MAYO

  • 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
SMX CEREBRAL SPINAL FLUID
UTAK LABORATORIES, INC.
SMX CSF 50 NWMH
In Commercial Distribution

  • B800SMXCSF50NWMH5 ()
  • B800SMXCSF50NWMH0 ()

  • Total Volume: 2 Milliliter
SMX CSF 50 NWMH

  • 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
SELENIUM QC HIGH
UTAK LABORATORIES, INC.
SELEN QC H S F UCSD
In Commercial Distribution

  • B800SELENQCHSFUCSD5 ()
  • B800SELENQCHSFUCSD0 ()

  • Total Volume: 3 Milliliter
SELEN QC H S F UCSD

  • Multiple-type clinical chemistry analyte profile IVD, control
SECO2FWBAHT
UTAK LABORATORIES, INC.
SECO+ 2 F WB AHT
In Commercial Distribution

  • B800SECO2FWBAHT5 ()
  • B800SECO2FWBAHT0 ()

  • Total Volume: 5 Milliliter
SECO+ 2 F WB AHT

  • Multiple-type clinical chemistry analyte profile IVD, control
SECO1FWBAHT
UTAK LABORATORIES, INC.
SECO+ 1 F WB AHT
In Commercial Distribution

  • B800SECO1FWBAHT5 ()
  • B800SECO1FWBAHT0 ()

  • Total Volume: 5 Milliliter
SECO+ 1 F WB AHT

  • Multiple-type clinical chemistry analyte profile IVD, control
ISAVUCONAZOLE PLUS CALIBRATOR 2
UTAK LABORATORIES, INC.
ISA+ CAL 2 S F UCSF
In Commercial Distribution

  • B800SACAL2SFUCSF5 ()
  • B800SACAL2SFUCSF0 ()

  • Total Volume: 0.5 Milliliter
ISA+ CAL 2 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
RT3 LEVEL 3
UTAK LABORATORIES, INC.
RT3 3 S F PG
In Commercial Distribution

  • B800RT33SFPG5 ()
  • B800RT33SFPG0 ()

  • Total Volume: 2.5 Milliliter
RT3 3 S F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
RT3 LEVEL 2
UTAK LABORATORIES, INC.
RT3 2 S F PG
In Commercial Distribution

  • B800RT32SFPG5 ()
  • B800RT32SFPG0 ()

  • Total Volume: 2.5 Milliliter
RT3 2 S F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
RT3 LEVEL 1
UTAK LABORATORIES, INC.
RT3 1 S F PG
In Commercial Distribution

  • B800RT31SFPG5 ()
  • B800RT31SFPG0 ()

  • Total Volume: 2.5 Milliliter
RT3 1 S F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
QC LEVEL 3 V3
UTAK LABORATORIES, INC.
QC V3 C-3 U F AP
In Commercial Distribution

  • B800QCV3C3UFAP5 ()
  • B800QCV3C3UFAP0 ()

  • Total Volume: 5 Milliliter
QC V3 C-3 U F AP

  • Multiple-type clinical chemistry analyte profile IVD, control
QC LEVEL 2 V3
UTAK LABORATORIES, INC.
QC V3 C-2 U F AP
In Commercial Distribution

  • B800QCV3C2UFAP5 ()
  • B800QCV3C2UFAP0 ()

  • Total Volume: 5 Milliliter
QC V3 C-2 U F AP

  • Multiple-type clinical chemistry analyte profile IVD, control
QC LEVEL 1 V3
UTAK LABORATORIES, INC.
QC V3 C-1 U F AP
In Commercial Distribution

  • B800QCV3C1UFAP5 ()
  • B800QCV3C1UFAP0 ()

  • Total Volume: 5 Milliliter
QC V3 C-1 U F AP

  • 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
DRUGS OF ABUSE QC A LEVEL 3
UTAK LABORATORIES, INC.
QC A3 OF F WHPM
In Commercial Distribution

  • B800QCA3OFFWHPM5 ()
  • B800QCA3OFFWHPM0 ()

  • Total Volume: 3 Milliliter
QC A3 OF F WHPM

  • Multiple-type clinical chemistry analyte profile IVD, control
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
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