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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THC CONTROL 1
UTAK LABORATORIES, INC.
THC QC 1 U F WDH
In Commercial Distribution

  • B800THCQC1UFWDH5 ()
  • B800THCQC1UFWDH0 ()

  • Total Volume: 10 Milliliter
THC QC 1 U F WDH

  • Multiple-type clinical chemistry analyte profile IVD, control
THC CONTROL 0
UTAK LABORATORIES, INC.
THC QC 0 U F WDH
In Commercial Distribution

  • B800THCQC0UFWDH5 ()
  • B800THCQC0UFWDH0 ()

  • Total Volume: 10 Milliliter
THC QC 0 U F WDH

  • Multiple-type clinical chemistry analyte profile IVD, control
THC LEVEL 8
UTAK LABORATORIES, INC.
THC 8 U F WDH
In Commercial Distribution

  • B800THC8UFWDH5 ()
  • B800THC8UFWDH0 ()

  • Total Volume: 10 Milliliter
THC 8 U F WDH

  • Multiple-type clinical chemistry analyte profile IVD, control
THC LEVEL 7
UTAK LABORATORIES, INC.
THC 7 U F WDH
In Commercial Distribution

  • B800THC7UFWDH5 ()
  • B800THC7UFWDH0 ()

  • Total Volume: 10 Milliliter
THC 7 U F WDH

  • Multiple-type clinical chemistry analyte profile IVD, control
THC LEVEL 6
UTAK LABORATORIES, INC.
THC 6 U F WDH
In Commercial Distribution

  • B800THC6UFWDH5 ()
  • B800THC6UFWDH0 ()

  • Total Volume: 10 Milliliter
THC 6 U F WDH

  • Multiple-type clinical chemistry analyte profile IVD, control
THC LEVEL 5
UTAK LABORATORIES, INC.
THC 5 U F WDH
In Commercial Distribution

  • B800THC5UFWDH5 ()
  • B800THC5UFWDH0 ()

  • Total Volume: 10 Milliliter
THC 5 U F WDH

  • Multiple-type clinical chemistry analyte profile IVD, control
THC LEVEL 4
UTAK LABORATORIES, INC.
THC 4 U F WDH
In Commercial Distribution

  • B800THC4UFWDH5 ()
  • B800THC4UFWDH0 ()

  • Total Volume: 10 Milliliter
THC 4 U F WDH

  • Multiple-type clinical chemistry analyte profile IVD, control
THC PLUS LEVEL 3
UTAK LABORATORIES, INC.
THC+ 3 WB 2PT F LSA
In Commercial Distribution

  • B800THC3WB2PTFLSA5 ()
  • B800THC3WB2PTFLSA0 ()
THC+ 3 WB 2PT F LSA

  • Multiple-type clinical chemistry analyte profile IVD, control
THC LEVEL 3
UTAK LABORATORIES, INC.
THC 3 U F WDH
In Commercial Distribution

  • B800THC3UFWDH5 ()
  • B800THC3UFWDH0 ()

  • Total Volume: 10 Milliliter
THC 3 U F WDH

  • Multiple-type clinical chemistry analyte profile IVD, control
THC PLUS LEVEL 2
UTAK LABORATORIES, INC.
THC+ 2 WB 2PT F SDHL
In Commercial Distribution

  • B800THC2WB2PTFSDHL5 ()
  • B800THC2WB2PTFSDHL0 ()

  • Total Volume: 1 Milliliter
THC+ 2 WB 2PT F SDHL

  • Multiple-type clinical chemistry analyte profile IVD, control
THC PLUS LEVEL 2
UTAK LABORATORIES, INC.
THC+ 2 WB 2PT F LSA
In Commercial Distribution

  • B800THC2WB2PTFLSA5 ()
  • B800THC2WB2PTFLSA0 ()
THC+ 2 WB 2PT F LSA

  • Multiple-type clinical chemistry analyte profile IVD, control
THC PLUS LEVEL 2
UTAK LABORATORIES, INC.
THC+ 2 V WB F EPCCO
In Commercial Distribution

  • B800THC2VWBFEPCCO5 ()
  • B800THC2VWBFEPCCO0 ()

  • Total Volume: 3 Milliliter
THC+ 2 V WB F EPCCO

  • Multiple drugs of abuse IVD, control
THC LEVEL 2
UTAK LABORATORIES, INC.
THC 2 U F WDH
In Commercial Distribution

  • B800THC2UFWDH5 ()
  • B800THC2UFWDH0 ()

  • Total Volume: 10 Milliliter
THC 2 U F WDH

  • Multiple-type clinical chemistry analyte profile IVD, control
THC-COOH 25 NG/ML
UTAK LABORATORIES, INC.
THC 25 U F SDHL
In Commercial Distribution

  • B800THC25UFSDHL5 ()
  • B800THC25UFSDHL0 ()

  • Total Volume: 10 Milliliter
THC 25 U F SDHL

  • Multiple drugs of abuse IVD, control
THC PLUS LEVEL 1
UTAK LABORATORIES, INC.
THC+ 1 WB 2PT F SDHL
In Commercial Distribution

  • B800THC1WB2PTFSDHL5 ()
  • B800THC1WB2PTFSDHL0 ()

  • Total Volume: 1 Milliliter
THC+ 1 WB 2PT F SDHL

  • Multiple-type clinical chemistry analyte profile IVD, control
THC PLUS LEVEL 1
UTAK LABORATORIES, INC.
THC+ 1 WB 2PT F LSA
In Commercial Distribution

  • B800THC1WB2PTFLSA5 ()
  • B800THC1WB2PTFLSA0 ()
THC+ 1 WB 2PT F LSA

  • Multiple-type clinical chemistry analyte profile IVD, control
THC PLUS LEVEL 1
UTAK LABORATORIES, INC.
THC+ 1 V WB F EPCCO
In Commercial Distribution

  • B800THC1VWBFEPCCO5 ()
  • B800THC1VWBFEPCCO0 ()

  • Total Volume: 3 Milliliter
THC+ 1 V WB F EPCCO

  • Multiple drugs of abuse IVD, control
THC LEVEL 1
UTAK LABORATORIES, INC.
THC 1 U F WDH
In Commercial Distribution

  • B800THC1UFWDH5 ()
  • B800THC1UFWDH0 ()

  • Total Volume: 10 Milliliter
THC 1 U F WDH

  • Multiple-type clinical chemistry analyte profile IVD, control
THC LEVEL 12
UTAK LABORATORIES, INC.
THC 12 U F WDH
In Commercial Distribution

  • B800THC12UFWDH5 ()
  • B800THC12UFWDH0 ()

  • Total Volume: 10 Milliliter
THC 12 U F WDH

  • Multiple-type clinical chemistry analyte profile IVD, control
THC LEVEL 11
UTAK LABORATORIES, INC.
THC 11 U F WDH
In Commercial Distribution

  • B800THC11UFWDH5 ()
  • B800THC11UFWDH0 ()

  • Total Volume: 10 Milliliter
THC 11 U F WDH

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

  • B800THC1000UFSDHL5 ()
  • B800THC1000UFSDHL0 ()

  • Total Volume: 10 Milliliter
THC 1000 U F SDHL

  • Multiple drugs of abuse IVD, control
THC LEVEL 0
UTAK LABORATORIES, INC.
THC 0 U F WDH
In Commercial Distribution

  • B800THC0UFWDH5 ()
  • B800THC0UFWDH0 ()

  • Total Volume: 10 Milliliter
THC 0 U F WDH

  • Multiple-type clinical chemistry analyte profile IVD, control
TESTOSTERONE LEVEL H
UTAK LABORATORIES, INC.
TESTO H SMX-S F UCH
In Commercial Distribution

  • B800TESTOHSMXSFUCH5 ()
  • B800TESTOHSMXSFUCH0 ()

  • Total Volume: 2 Milliliter
TESTO H SMX-S F UCH

  • Multiple drugs of abuse IVD, control
TESTOSTERONE LEVEL G
UTAK LABORATORIES, INC.
TESTO G SMX-S F UCH
In Commercial Distribution

  • B800TESTOGSMXSFUCH5 ()
  • B800TESTOGSMXSFUCH0 ()

  • Total Volume: 2 Milliliter
TESTO G SMX-S F UCH

  • Multiple drugs of abuse IVD, control
TESTOSTERONE LEVEL F
UTAK LABORATORIES, INC.
TESTO F SMX-S F UCH
In Commercial Distribution

  • B800TESTOFSMXSFUCH5 ()
  • B800TESTOFSMXSFUCH0 ()

  • Total Volume: 2 Milliliter
TESTO F SMX-S F UCH

  • Multiple drugs of abuse IVD, control
TESTOSTERONE LEVEL E
UTAK LABORATORIES, INC.
TESTO E SMX-S F UCH
In Commercial Distribution

  • B800TESTOESMXSFUCH5 ()
  • B800TESTOESMXSFUCH0 ()

  • Total Volume: 2 Milliliter
TESTO E SMX-S F UCH

  • Multiple drugs of abuse IVD, control
TESTOSTERONE LEVEL D
UTAK LABORATORIES, INC.
TESTO D SMX-S F UCH
In Commercial Distribution

  • B800TESTODSMXSFUCH5 ()
  • B800TESTODSMXSFUCH0 ()

  • Total Volume: 2 Milliliter
TESTO D SMX-S F UCH

  • Multiple drugs of abuse IVD, control
TESTOSTERONE LEVEL C
UTAK LABORATORIES, INC.
TESTO C SMX-S F UCH
In Commercial Distribution

  • B800TESTOCSMXSFUCH5 ()
  • B800TESTOCSMXSFUCH0 ()

  • Total Volume: 2 Milliliter
TESTO C SMX-S F UCH

  • Multiple drugs of abuse IVD, control
TESTOSTERONE LEVEL B
UTAK LABORATORIES, INC.
TESTO B SMX-S F UCH
In Commercial Distribution

  • B800TESTOBSMXSFUCH5 ()
  • B800TESTOBSMXSFUCH0 ()

  • Total Volume: 2 Milliliter
TESTO B SMX-S F UCH

  • Multiple drugs of abuse IVD, control
TESTOSTERONE LEVEL A
UTAK LABORATORIES, INC.
TESTO A SMX-S F UCH
In Commercial Distribution

  • B800TESTOASMXSFUCH5 ()
  • B800TESTOASMXSFUCH0 ()

  • Total Volume: 2 Milliliter
TESTO A SMX-S F UCH

  • Multiple drugs of abuse IVD, control
TESTOSTERONE 7.5 NG/DL
UTAK LABORATORIES, INC.
TESTO 7.5 V2 S F LCMS
In Commercial Distribution

  • B800TESTO75V2SFLCMS5 ()
  • B800TESTO75V2SFLCMS0 ()

  • Total Volume: 1.1 Milliliter
TESTO 7.5 V2 S F LCMS

  • Multiple-type clinical chemistry analyte profile IVD, control
TESTOSTERONE 600 NG/DL
UTAK LABORATORIES, INC.
TESTO 600 S KPRICH
In Commercial Distribution

  • B800TESTO600SKPRICH5 ()
  • B800TESTO600SKPRICH0 ()

  • Total Volume: 4 Milliliter
TESTO 600 S KPRICH

  • Multiple-type clinical chemistry analyte profile IVD, control
TESTOSTERONE LEVEL 3
UTAK LABORATORIES, INC.
TESTO 3 SMX-S F UCH
In Commercial Distribution

  • B800TESTO3SMXSFUC50 ()
  • B800TESTO3SMXSFUCH0 ()

  • Total Volume: 3 Milliliter
TESTO 3 SMX-S F UCH

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

  • B800TESTO3SFMC5 ()
  • B800TESTO3SFMC0 ()

  • Total Volume: 10 Milliliter
TESTO 3 S F MC

  • Multiple-type clinical chemistry analyte profile IVD, control
VOLATILES 400 MG/DL V2
UTAK LABORATORIES, INC.
VOL 400 WB F V2 HCMC
In Commercial Distribution

  • B800VOL400WBFV2HCMC5 ()
  • B800VOL400WBFV2HCMC0 ()

  • Total Volume: 3 Milliliter
VOL 400 WB F V2 HCMC

  • Multiple-type clinical chemistry analyte profile IVD, control
VOLATILES LEVEL 2
UTAK LABORATORIES, INC.
VOL 2 V2 S F RIH
In Commercial Distribution

  • B800VOL2V2SFRIH5 ()
  • B800VOL2V2SFRIH0 ()

  • Total Volume: 5 Milliliter
VOL 2 V2 S F RIH

  • Multiple drugs of abuse IVD, control
VOLATILES
UTAK LABORATORIES, INC.
VOL 1 WB F OCMEO
In Commercial Distribution

  • B800VOL1WBFOCMEO5 ()
  • B800VOL1WBFOCMEO0 ()

  • Total Volume: 50 Milliliter
VOL 1 WB F OCMEO

  • Multiple-type clinical chemistry analyte profile IVD, control
VOLATILES LEVEL 1
UTAK LABORATORIES, INC.
VOL 1 V2 S F RIH
In Commercial Distribution

  • B800VOL1V2SFRIH5 ()
  • B800VOL1V2SFRIH0 ()

  • Total Volume: 5 Milliliter
VOL 1 V2 S F RIH

  • Multiple drugs of abuse IVD, control
VITAMIN D3 500 NG/ML
UTAK LABORATORIES, INC.
VIT D3 500 S F BD
In Commercial Distribution

  • B800VITD3500SFBD0 ()

  • Total Volume: 10 Milliliter
VIT D3 500 S F BD

  • Multiple drugs of abuse IVD, control
VITAMIN D PLUS 150 NG/ML
UTAK LABORATORIES, INC.
VIT D+ 150 S CH
In Commercial Distribution

  • B800VITD150SCH5 ()
  • B800VITD150SCH0 ()

  • Total Volume: 5 Milliliter
VIT D+ 150 S CH

  • Multiple-type clinical chemistry analyte profile IVD, control
VITAMIN B6 LEVEL 2
UTAK LABORATORIES, INC.
VIT B6 2 S F UCD
In Commercial Distribution

  • B800VITB62SFUCD5 ()
  • B800VITB62SFUCD0 ()

  • Total Volume: 5 Milliliter
VIT B6 2 S F UCD

  • Multiple-type clinical chemistry analyte profile IVD, control
PREGNENOLONE CONTROL
UTAK LABORATORIES, INC.
UTAK-SC PREG S F SD
In Commercial Distribution

  • B800UTAKSCPREGSFSD5 ()
  • B800UTAKSCPREGSFSD0 ()

  • Total Volume: 2 Milliliter
UTAK-SC PREG S F SD

  • Multiple-type clinical chemistry analyte profile IVD, control
METALS QC 2
UTAK LABORATORIES, INC.
UTAK-SC MET QC 2 S F SD
In Commercial Distribution

  • B800UTAKSCMETQC2SFSD5 ()
  • B800UTAKSCMETQC2SFSD0 ()

  • Total Volume: 5 Milliliter
UTAK-SC MET QC 2 S F SD

  • Multiple-type clinical chemistry analyte profile IVD, control
GLYCOLS LEVEL 2
UTAK LABORATORIES, INC.
UTAK-SC GLY 2 P SD
In Commercial Distribution

  • B800UTAKSCGLY2PSD5 ()
  • B800UTAKSCGLY2PSD0 ()

  • Total Volume: 5 Milliliter
UTAK-SC GLY 2 P SD

  • Multiple-type clinical chemistry analyte profile IVD, control
CLOZAPINE PLUS LEVEL 2
UTAK LABORATORIES, INC.
UTAK- SC CLOZ S F SD 2
In Commercial Distribution

  • B800UTAKSCCLOZSFSD25 ()
  • B800UTAKSCCLOZSFSD20 ()

  • Total Volume: 5 Milliliter
UTAK- SC CLOZ S F SD 2

  • Multiple-type clinical chemistry analyte profile IVD, control
TESTOSTERONE LEVEL 2
UTAK LABORATORIES, INC.
TESTO 2 SMX-S F UCH
In Commercial Distribution

  • B800TESTO2SMXSFUCH5 ()
  • B800TESTO2SMXSFUCH0 ()

  • Total Volume: 3 Milliliter
TESTO 2 SMX-S F UCH

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

  • B800TESTO2SFMC5 ()
  • B800TESTO2SFMC0 ()

  • Total Volume: 10 Milliliter
TESTO 2 S F MC

  • Multiple-type clinical chemistry analyte profile IVD, control
TESTOSTERONE 250 NG/DL
UTAK LABORATORIES, INC.
TESTO 250 V3 S F PG
In Commercial Distribution

  • B800TESTO250V3SFPG5 ()
  • B800TESTO250V3SFPG0 ()

  • Total Volume: 5 Milliliter
TESTO 250 V3 S F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
TESTOSTERONE 250 NMOL/L
UTAK LABORATORIES, INC.
TESTO 250 S F BD
In Commercial Distribution

  • B800TESTO250SFBD5 ()
  • B800TESTO250SFBD0 ()

  • Total Volume: 10 Milliliter
TESTO 250 S F BD

  • Multiple-type clinical chemistry analyte profile IVD, control
TESTOSTERONE 200 NG/DL
UTAK LABORATORIES, INC.
TESTO 200 S KPRICH
In Commercial Distribution

  • B800TESTO200SKPRICH5 ()
  • B800TESTO200SKPRICH0 ()

  • Total Volume: 4 Milliliter
TESTO 200 S KPRICH

  • Multiple-type clinical chemistry analyte profile IVD, control
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