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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ETG PLUS QC LEVEL 3 V2
UTAK LABORATORIES, INC.
ETG+ QC 3 V2 U F UCSF
In Commercial Distribution

  • B800ETGQC3V2UFUCSF5 ()
  • B800ETGQC3V2UFUCSF0 ()

  • Total Volume: 1 Milliliter
ETG+ QC 3 V2 U F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS QC LEVEL 2 V2
UTAK LABORATORIES, INC.
ETG+ QC 2 V2 U F UCSF
In Commercial Distribution

  • B800ETGQC2V2UFUCSF5 ()
  • B800ETGQC2V2UFUCSF0 ()

  • Total Volume: 1 Milliliter
ETG+ QC 2 V2 U F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS QC LEVEL 1 V2
UTAK LABORATORIES, INC.
ETG+ QC 1 V2 U F UCSF
In Commercial Distribution

  • B800ETGQC1V2UFUCSF5 ()
  • B800ETGQC1V2UFUCSF0 ()

  • Total Volume: 1 Milliliter
ETG+ QC 1 V2 U F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS MID
UTAK LABORATORIES, INC.
ETG+ M MAYO
In Commercial Distribution

  • B800ETGMMAYO5 ()
  • B800ETGMMAYO0 ()

  • Total Volume: 0.3 Milliliter
ETG+ M MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS LOW
UTAK LABORATORIES, INC.
ETG+ LOW F SMXU NWMH
In Commercial Distribution

  • B800ETGLOWFSMXUNWMH5 ()
  • B800ETGLOWFSMXUNWMH0 ()

  • Total Volume: 1 Milliliter
ETG+ LOW F SMXU NWMH

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS HIGH
UTAK LABORATORIES, INC.
ETG+ HIGH F SMXU NWMH
In Commercial Distribution

  • B800ETGHIGHFSMXUNWMH5 ()
  • B800ETGHIGHFSMXUNWMH0 ()

  • Total Volume: 1 Milliliter
ETG+ HIGH F SMXU NWMH

  • Multiple-type clinical chemistry analyte profile IVD, control
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
ETG PLUS CALIBRATOR LEVEL 6
UTAK LABORATORIES, INC.
ETG+ CAL 6 V2 U F UCSF
In Commercial Distribution

  • B800ETGCAL6V2UFUCSF5 ()
  • B800ETGCAL6V2UFUCSF0 ()

  • Total Volume: 1 Milliliter
ETG+ CAL 6 V2 U F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS CALIBRATOR 6
UTAK LABORATORIES, INC.
ETG+ CAL 6 U F NPIL
In Commercial Distribution

  • B800ETGCAL6UFNPIL5 ()
  • B800ETGCAL6UFNPIL0 ()

  • Total Volume: 2 Milliliter
ETG+ CAL 6 U F NPIL

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS CALIBRATOR LEVEL 5
UTAK LABORATORIES, INC.
ETG+ CAL 5 V2 U F UCSF
In Commercial Distribution

  • B800ETGCAL5V2UFUCSF5 ()
  • B800ETGCAL5V2UFUCSF0 ()

  • Total Volume: 1 Milliliter
ETG+ CAL 5 V2 U F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS CALIBRATOR 5
UTAK LABORATORIES, INC.
ETG+ CAL 5 U F NPIL
In Commercial Distribution

  • B800ETGCAL5UFNPIL5 ()
  • B800ETGCAL5UFNPIL0 ()

  • Total Volume: 2 Milliliter
ETG+ CAL 5 U F NPIL

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS CALIBRATOR LEVEL 4
UTAK LABORATORIES, INC.
ETG+ CAL 4 V2 U F UCSF
In Commercial Distribution

  • B800ETGCAL4V2UFUCSF5 ()
  • B800ETGCAL4V2UFUCSF0 ()

  • Total Volume: 1 Milliliter
ETG+ CAL 4 V2 U F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS CALIBRATOR 4
UTAK LABORATORIES, INC.
ETG+ CAL 4 U F NPIL
In Commercial Distribution

  • B800ETGCAL4UFNPIL5 ()
  • B800ETGCAL4UFNPIL0 ()

  • Total Volume: 2 Milliliter
ETG+ CAL 4 U F NPIL

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS CALIBRATOR LEVEL 3
UTAK LABORATORIES, INC.
ETG+ CAL 3 V2 U F UCSF
In Commercial Distribution

  • B800ETGCAL3V2UFUCSF5 ()
  • B800ETGCAL3V2UFUCSF0 ()

  • Total Volume: 1 Milliliter
ETG+ CAL 3 V2 U F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS CALIBRATOR 3
UTAK LABORATORIES, INC.
ETG+ CAL 3 U F NPIL
In Commercial Distribution

  • B800ETGCAL3UFNPIL5 ()
  • B800ETGCAL3UFNPIL0 ()

  • Total Volume: 2 Milliliter
ETG+ CAL 3 U F NPIL

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS CALIBRATOR LEVEL 2
UTAK LABORATORIES, INC.
ETG+ CAL 2 V2 U F UCSF
In Commercial Distribution

  • B800ETGCAL2V2UFUCSF5 ()
  • B800ETGCAL2V2UFUCSF0 ()

  • Total Volume: 1 Milliliter
ETG+ CAL 2 V2 U F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS CALIBRATOR 2
UTAK LABORATORIES, INC.
ETG+ CAL 2 U F NPIL
In Commercial Distribution

  • B800ETGCAL2UFNPIL5 ()
  • B800ETGCAL2UFNPIL0 ()

  • Total Volume: 2 Milliliter
ETG+ CAL 2 U F NPIL

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS CALIBRATOR LEVEL 1
UTAK LABORATORIES, INC.
ETG+ CAL 1 V2 U F UCSF
In Commercial Distribution

  • B800ETGCAL1V2UFUCSF5 ()
  • B800ETGCAL1V2UFUCSF0 ()

  • Total Volume: 1 Milliliter
ETG+ CAL 1 V2 U F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS CALIBRATOR 1
UTAK LABORATORIES, INC.
ETG+ CAL 1 U F NPIL
In Commercial Distribution

  • B800ETGCAL1UFNPIL5 ()
  • B800ETGCAL1UFNPIL0 ()

  • Total Volume: 2 Milliliter
ETG+ CAL 1 U F NPIL

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS LEVEL 3
UTAK LABORATORIES, INC.
ETG+ 3 V2 U F CCL
In Commercial Distribution

  • B800ETG3V2UFCCL5 ()
  • B800ETG3V2UFCCL0 ()

  • Total Volume: 2 Milliliter
ETG+ 3 V2 U F CCL

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS LEVEL 2
UTAK LABORATORIES, INC.
ETG+ 2 V2 U F CCL
In Commercial Distribution

  • B800ETG2V2UFCCL5 ()
  • B800ETG2V2UFCCL0 ()

  • Total Volume: 2 Milliliter
ETG+ 2 V2 U F CCL

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

  • B800ETG2UFKNH5 ()
  • B800ETG2UFKNH0 ()

  • Total Volume: 2 Milliliter
ETG 2 U F KNH

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS LEVEL 1
UTAK LABORATORIES, INC.
ETG+ 1 V2 U F CCL
In Commercial Distribution

  • B800ETG1V2UFCCL5 ()
  • B800ETG1V2UFCCL0 ()

  • Total Volume: 2 Milliliter
ETG+ 1 V2 U F CCL

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS LEVEL 1
UTAK LABORATORIES, INC.
ETG 1 U F KNH
In Commercial Distribution

  • B800ETG1UFKNH5 ()
  • B800ETG1UFKNH0 ()

  • Total Volume: 2 Milliliter
ETG 1 U F KNH

  • Multiple-type clinical chemistry analyte profile IVD, control
ESTRONE PLUS 400 PG/ML
UTAK LABORATORIES, INC.
ESTRO+ 400 S F BRL
In Commercial Distribution

  • B800ESTRO400SFBRL5 ()
  • B800ESTRO400SFBRL0 ()

  • Total Volume: 1 Milliliter
ESTRO+ 400 S F BRL

  • Multiple-type clinical chemistry analyte profile IVD, control
ESTRONE PLUS 25 PG/ML
UTAK LABORATORIES, INC.
ESTRO+ 25 S F BRL
In Commercial Distribution

  • B800ESTRO25SFBRL5 ()
  • B800ESTRO25SFBRL0 ()

  • Total Volume: 1 Milliliter
ESTRO+ 25 S F BRL

  • Multiple-type clinical chemistry analyte profile IVD, control
ESTRONE PLUS 150 PG/ML
UTAK LABORATORIES, INC.
ESTRO+ 150 S F BRL
In Commercial Distribution

  • B800ESTRO150SFBRL5 ()
  • B800ESTRO150SFBRL0 ()

  • Total Volume: 1 Milliliter
ESTRO+ 150 S F BRL

  • Multiple-type clinical chemistry analyte profile IVD, control
EIA STANDARD V3
UTAK LABORATORIES, INC.
EIA STD V3 WB DOJ
In Commercial Distribution

  • B800EIASTDV3WBDOJ5 ()
  • B800EIASTDV3WBDOJ0 ()

  • Total Volume: 2 Milliliter
EIA STD V3 WB DOJ

  • Multiple-type clinical chemistry analyte profile IVD, control
EIA NEGATIVE CALIBRATOR
UTAK LABORATORIES, INC.
EIA NEG U F RX
In Commercial Distribution

  • B800EIANEGUFRX5 ()
  • B800EIANEGUFRX0 ()

  • Total Volume: 5 Milliliter
EIA NEG U F RX

  • Multiple-type clinical chemistry analyte profile IVD, control
EIA CALIBRATOR LEVEL 2
UTAK LABORATORIES, INC.
EIA CAL 2 U F RX
In Commercial Distribution

  • B800EIACAL2UFRX5 ()
  • B800EIACAL2UFRX0 ()

  • Total Volume: 5 Milliliter
EIA CAL 2 U F RX

  • Multiple-type clinical chemistry analyte profile IVD, control
EIA CALIBRATOR LEVEL 1
UTAK LABORATORIES, INC.
EIA CAL 1 U F RX
In Commercial Distribution

  • B800EIACAL1UFRX5 ()
  • B800EIACAL1UFRX0 ()

  • Total Volume: 5 Milliliter
EIA CAL 1 U F RX

  • Multiple-type clinical chemistry analyte profile IVD, control
EIA C2 V3
UTAK LABORATORIES, INC.
EIA C2 V3 U F DOJ
In Commercial Distribution

  • B800EIAC2V3UFDOJ5 ()
  • B800EIAC2V3UFDOJ0 ()

  • Total Volume: 2 Milliliter
EIA C2 V3 U F DOJ

  • Multiple-type clinical chemistry analyte profile IVD, control
EIA C1 V3
UTAK LABORATORIES, INC.
EIA C1 V3 WB DOJ
In Commercial Distribution

  • B800EIAC1V3WBDOJ5 ()
  • B800EIAC1V3WBDOJ0 ()

  • Total Volume: 2 Milliliter
EIA C1 V3 WB DOJ

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

  • B800EDTASMXWBFMC5 ()
  • B800EDTASMXWBFMC0 ()

  • Total Volume: 250 Milliliter
EDTA SMX-WB F MC

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUG SCREEN
UTAK LABORATORIES, INC.
DRUG SCR M SCIEX
In Commercial Distribution

  • B800DRUGSCRMSCIEX5 ()
  • B800DRUGSCRMSCIEX0 ()

  • Total Volume: 1 Milliliter
DRUG SCR M SCIEX

  • Multiple-type clinical chemistry analyte profile IVD, control
DEFIBRINATED PLASMA
UTAK LABORATORIES, INC.
DP 5 V2 OVMC
In Commercial Distribution

  • B800DP5V2OVMC5 ()
  • B800DP5V2OVMC0 ()

  • Total Volume: 5 Milliliter
DP 5 V2 OVMC

  • Multiple-type clinical chemistry analyte profile IVD, control
DEFIBRINATED PLASMA
UTAK LABORATORIES, INC.
DP 5 OVMC
In Commercial Distribution

  • B800DP5OVMC5 ()
  • B800DP5OVMC0 ()

  • Total Volume: 5 Milliliter
DP 5 OVMC

  • Multiple-type clinical chemistry analyte profile IVD, control
DEFIBRINATED PLASMA
UTAK LABORATORIES, INC.
DP 10 F LAC/USC
In Commercial Distribution

  • B800DP10FLACUSC5 ()
  • B800DP10FLACUSC0 ()

  • Total Volume: 10 Milliliter
DP 10 F LAC/USC

  • Multiple-type clinical chemistry analyte profile IVD, control
DOXYLAMINE SUCCINATE 800 NG/ML
UTAK LABORATORIES, INC.
DOXYL WB F NMS
In Commercial Distribution

  • B800DOXYLWBFNMS5 ()
  • B800DOXYLWBFNMS0 ()

  • Total Volume: 5 Milliliter
DOXYL WB F NMS

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE CALIBRATOR
UTAK LABORATORIES, INC.
DOA CAL M F ACL
In Commercial Distribution

  • B800DOACALMFACL0 ()
  • B800DOACALMFACL5 ()

  • Total Volume: 3 Milliliter
DOA CAL M F ACL

  • Multiple therapeutic drugs/drugs of abuse IVD, control
DRUGS OF ABUSE LEVEL 3
UTAK LABORATORIES, INC.
DOA 3 SMX-OF MMC
In Commercial Distribution

  • B800DOA3SMXOFMMC5 ()
  • B800DOA3SMXOFMMC0 ()

  • Total Volume: 5 Milliliter
DOA 3 SMX-OF MMC

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LEVEL 3
UTAK LABORATORIES, INC.
DOA 3 i2he OF F MMC
In Commercial Distribution

  • B800DOA3I2HEOFFMMC5 ()
  • B800DOA3I2HEOFFMMC0 ()

  • Total Volume: 3 Milliliter
DOA 3 i2he OF F MMC

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LEVEL 3
UTAK LABORATORIES, INC.
DOA 3 EXTBUF OF F MMC
In Commercial Distribution

  • B800DOA3EXTBUFOFFMMC5 ()
  • B800DOA3EXTBUFOFFMMC0 ()

  • Total Volume: 3 Milliliter
DOA 3 EXTBUF OF F MMC

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

  • B800DOA2SMXOFMMC5 ()
  • B800DOA2SMXOFMMC0 ()

  • Total Volume: 5 Milliliter
DOA 2 SMX-OF MMC

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LEVEL 2
UTAK LABORATORIES, INC.
DOA 2 M F ACL
In Commercial Distribution

  • B800DOA2MFACL5 ()
  • B800DOA2MFACL0 ()

  • Total Volume: 3 Milliliter
DOA 2 M F ACL

  • Multiple therapeutic drugs/drugs of abuse IVD, control
DRUGS OF ABUSE LEVEL 2
UTAK LABORATORIES, INC.
DOA 2 i2he OF F MMC
In Commercial Distribution

  • B800DOA2I2HEOFFMMC5 ()
  • B800DOA2I2HEOFFMMC0 ()

  • Total Volume: 3 Milliliter
DOA 2 i2he OF F MMC

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LEVEL 2
UTAK LABORATORIES, INC.
DOA 2 EXTBUF OF F MMC
In Commercial Distribution

  • B800DOA2EXTBUFOFFMMC5 ()
  • B800DOA2EXTBUFOFFMMC0 ()

  • Total Volume: 3 Milliliter
DOA 2 EXTBUF OF F MMC

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

  • B800DOA1SMXOFMMC5 ()
  • B800DOA1SMXOFMMC0 ()

  • Total Volume: 5 Milliliter
DOA 1 SMX-OF MMC

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LEVEL 1
UTAK LABORATORIES, INC.
DOA 1 M F ACL
In Commercial Distribution

  • B800DOA1MFACL5 ()
  • B800DOA1MFACL0 ()

  • Total Volume: 3 Milliliter
DOA 1 M F ACL

  • Multiple therapeutic drugs/drugs of abuse IVD, control
DRUGS OF ABUSE LEVEL 1
UTAK LABORATORIES, INC.
DOA 1 i2he OF F MMC
In Commercial Distribution

  • B800DOA1I2HEOFFMMC5 ()
  • B800DOA1I2HEOFFMMC0 ()

  • Total Volume: 3 Milliliter
DOA 1 i2he OF F MMC

  • Multiple-type clinical chemistry analyte profile IVD, control
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