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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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DA SET 1 CUTOFF
UTAK LABORATORIES, INC.
DA 1 CUT WB NC
In Commercial Distribution

  • B800DA1CUTWBNC5 ()
  • B800DA1CUTWBNC0 ()

  • Total Volume: 2 Milliliter
DA 1 CUT WB NC

  • Multiple-type clinical chemistry analyte profile IVD, control
DA SET 1 CUTOFF
UTAK LABORATORIES, INC.
DA 1 CUT S NC
In Commercial Distribution

  • B800DA1CUTSNC5 ()
  • B800DA1CUTSNC0 ()

  • Total Volume: 2 Milliliter
DA 1 CUT S NC

  • Multiple therapeutic drugs/drugs of abuse IVD, control
CREATININE BASELINE
UTAK LABORATORIES, INC.
CREAT BL WB F LCG
In Commercial Distribution

  • B800CREATBLWBFLCG5 ()
  • B800CREATBLWBFLCG0 ()

  • Total Volume: 50 Milliliter
CREAT BL WB F LCG

  • Multiple-type clinical chemistry analyte profile IVD, control
CREATININE LEVEL 3
UTAK LABORATORIES, INC.
CREAT 3 WB F LCG
In Commercial Distribution

  • B800CREAT3WBFLCG0 ()

  • Total Volume: 50 Milliliter
CREAT 3 WB F LCG

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

  • B800CREAT2WBFLCG5 ()
  • B800CREAT2WBFLCG0 ()

  • Total Volume: 50 Milliliter
CREAT 2 WB F LCG

  • Multiple-type clinical chemistry analyte profile IVD, control
CREATININE LEVEL 1
UTAK LABORATORIES, INC.
CREAT 1 WB F LCG
In Commercial Distribution

  • B800CREAT1WBFLCG5 ()
  • B800CREAT1WBFLCG0 ()

  • Total Volume: 50 Milliliter
CREAT 1 WB F LCG

  • Multiple-type clinical chemistry analyte profile IVD, control
COTININE PLUS LEVEL 2
UTAK LABORATORIES, INC.
COT+ 2 S LC
In Commercial Distribution

  • B800COT2SLC5 ()
  • B800COT2SLC0 ()

  • Total Volume: 5 Milliliter
COT+ 2 S LC

  • Multiple-type clinical chemistry analyte profile IVD, control
COTININE PLUS LEVEL 1 V2
UTAK LABORATORIES, INC.
COT+ 1 V2 S LC
In Commercial Distribution

  • B800COT1V2SLC5 ()
  • B800COT1V2SLC0 ()

  • Total Volume: 5 Milliliter
COT+ 1 V2 S LC

  • Multiple-type clinical chemistry analyte profile IVD, control
COTININE PLUS LEVEL 1
UTAK LABORATORIES, INC.
COT+ 1 S LC
In Commercial Distribution

  • B800COT1SLC5 ()
  • B800COT1SLC0 ()

  • Total Volume: 5 Milliliter
COT+ 1 S LC

  • Multiple-type clinical chemistry analyte profile IVD, control
COTININE 100 NG/ML
UTAK LABORATORIES, INC.
COT 100 U F AHCH
In Commercial Distribution

  • B800COT100UFAHCH5 ()
  • B800COT100UFAHCH0 ()

  • Total Volume: 5 Milliliter
COT 100 U F AHCH

  • Multiple-type clinical chemistry analyte profile IVD, control
COTININE 1000 NG/ML
UTAK LABORATORIES, INC.
COT 1000 U F AHCH
In Commercial Distribution

  • B800COT1000UFAHCH5 ()
  • B800COT1000UFAHCH0 ()

  • Total Volume: 5 Milliliter
COT 1000 U F AHCH

  • Multiple-type clinical chemistry analyte profile IVD, control
CORTISOL CAL
UTAK LABORATORIES, INC.
CORT SMX-OF F ARUP
In Commercial Distribution

  • B800CORTSMXOFFARUP5 ()
  • B800CORTSMXOFFARUP0 ()

  • Total Volume: 50 Milliliter
CORT SMX-OF F ARUP

  • Multiple-type clinical chemistry analyte profile IVD, control
CORTISOL 7000 NMOL/L
UTAK LABORATORIES, INC.
CORT 7000 S F BD
In Commercial Distribution

  • B800CORT7000SFBD5 ()
  • B800CORT7000SFBD0 ()

  • Total Volume: 10 Milliliter
CORT 7000 S F BD

  • Multiple-type clinical chemistry analyte profile IVD, control
CORTISOL LEVEL 2
UTAK LABORATORIES, INC.
CORT 2 SMX-OF F PP
In Commercial Distribution

  • B800CORT2SMXOFFPP5 ()
  • B800CORT2SMXOFFPP0 ()

  • Total Volume: 2 Milliliter
CORT 2 SMX-OF F PP

  • Multiple-type clinical chemistry analyte profile IVD, control
CORTISOL CAL LEVEL 2
UTAK LABORATORIES, INC.
CORT 2 SMX-OF F ARUP
In Commercial Distribution

  • B800CORT2SMXOFFARUP5 ()
  • B800CORT2SMXOFFARUP0 ()

  • Total Volume: 50 Milliliter
CORT 2 SMX-OF F ARUP

  • Multiple-type clinical chemistry analyte profile IVD, control
CORTISOL LEVEL 1
UTAK LABORATORIES, INC.
CORT 1 SMX-OF F PP
In Commercial Distribution

  • B800CORT1SMXOFFPP5 ()
  • B800CORT1SMXOFFPP0 ()

  • Total Volume: 1 Milliliter
CORT 1 SMX-OF F PP

  • Multiple-type clinical chemistry analyte profile IVD, control
COPPER PLUS LEVEL 2
UTAK LABORATORIES, INC.
COP+ 2 V2 S F UW
In Commercial Distribution

  • B800COP2V2SFUW5 ()
  • B800COP2V2SFUW0 ()

  • Total Volume: 5 Milliliter
COP+ 2 V2 S F UW

  • Multiple-type clinical chemistry analyte profile IVD, control
COPPER PLUS LEVEL 1
UTAK LABORATORIES, INC.
COP+ 1 V2 S F UW
In Commercial Distribution

  • B800COP1V2SFUW5 ()
  • B800COP1V2SFUW0 ()

  • Total Volume: 5 Milliliter
COP+ 1 V2 S F UW

  • Multiple-type clinical chemistry analyte profile IVD, control
COMP TOX I_05 25
UTAK LABORATORIES, INC.
COMP TOX I_05 25
In Commercial Distribution

  • B800COMPTOXI05255 ()
  • B800COMPTOXI05250 ()

  • Total Volume: 1 Milliliter
COMP TOX I_05 25

  • Multiple-type clinical chemistry analyte profile IVD, control
COMP TOX I_04 25
UTAK LABORATORIES, INC.
COMP TOX I_04 25
In Commercial Distribution

  • B800COMPTOXI04255 ()
  • B800COMPTOXI04250 ()

  • Total Volume: 1 Milliliter
COMP TOX I_04 25

  • Multiple-type clinical chemistry analyte profile IVD, control
COMP TOX I_03 25
UTAK LABORATORIES, INC.
COMP TOX I_03 25
In Commercial Distribution

  • B800COMPTOXI03255 ()
  • B800COMPTOXI03250 ()

  • Total Volume: 1 Milliliter
COMP TOX I_03 25

  • Multiple-type clinical chemistry analyte profile IVD, control
COMP TOX I_02 25
UTAK LABORATORIES, INC.
COMP TOX I_02 25
In Commercial Distribution

  • B800COMPTOXI02255 ()
  • B800COMPTOXI02250 ()

  • Total Volume: 1 Milliliter
COMP TOX I_02 25

  • Multiple-type clinical chemistry analyte profile IVD, control
COMP TOX I_01 25
UTAK LABORATORIES, INC.
COMP TOX I_01 25
In Commercial Distribution

  • B800COMPTOXI01255 ()
  • B800COMPTOXI01250 ()

  • Total Volume: 1 Milliliter
COMP TOX I_01 25

  • Multiple-type clinical chemistry analyte profile IVD, control
COMBINED
UTAK LABORATORIES, INC.
COMB M TCAO
In Commercial Distribution

  • B800COMBMTCAO5 ()
  • B800COMBMTCAO0 ()

  • Total Volume: 50 Milliliter
COMB M TCAO

  • Multiple-type clinical chemistry analyte profile IVD, control
CODEINE-6-B-D-GLUCURONIDE PLUS
UTAK LABORATORIES, INC.
COD GLUC+ U F DS
In Commercial Distribution

  • B800CODGLUCUFDS5 ()
  • B800CODGLUCUFDS0 ()

  • Total Volume: 2.2 Milliliter
COD GLUC+ U F DS

  • Multiple-therapy therapeutic drug monitoring IVD, control
CODEINE GLUC PLUS LEVEL 2
UTAK LABORATORIES, INC.
COD GLUC+ 2 U F YNHH
In Commercial Distribution

  • B800CODGLUC2UFYNHH5 ()
  • B800CODGLUC2UFYNHH0 ()

  • Total Volume: 2.6 Milliliter
COD GLUC+ 2 U F YNHH

  • Multiple-type clinical chemistry analyte profile IVD, control
CODEINE GLUC PLUS LEVEL 1
UTAK LABORATORIES, INC.
COD GLUC+ 1 U F YNHH
In Commercial Distribution

  • B800CODGLUC1UFYNHH5 ()
  • B800CODGLUC1UFYNHH0 ()

  • Total Volume: 2.6 Milliliter
COD GLUC+ 1 U F YNHH

  • Multiple-type clinical chemistry analyte profile IVD, control
COCAMPH
UTAK LABORATORIES, INC.
COCAMPH M TCAU
In Commercial Distribution

  • B800COCAMPHMTCAU5 ()
  • B800COCAMPHMTCAU0 ()

  • Total Volume: 50 Milliliter
COCAMPH M TCAU

  • Multiple-type clinical chemistry analyte profile IVD, control
CLOZAPINE PLUS
UTAK LABORATORIES, INC.
CLOZ+ S AQ
In Commercial Distribution

  • B800CLOZSAQ5 ()
  • B800CLOZSAQ0 ()

  • Total Volume: 5 Milliliter
CLOZ+ S AQ

  • Multiple-type clinical chemistry analyte profile IVD, control
CLOFARABINE PLUS LEVEL 3
UTAK LABORATORIES, INC.
CLOF+ 3 DP F MSKCC
In Commercial Distribution

  • B800CLOF3DPFMSKCC5 ()
  • B800CLOF3DPFMSKCC0 ()

  • Total Volume: 0.5 Milliliter
CLOF+ 3 DP F MSKCC

  • Multiple-type clinical chemistry analyte profile IVD, control
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