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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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
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 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
TESTOSTERONE LEVEL 1
UTAK LABORATORIES, INC.
TESTO 1 SMX-S F UCH
In Commercial Distribution

  • B800TESTO1SMXSFUCH5 ()
  • B800TESTO1SMXSFUCH0 ()

  • Total Volume: 3 Milliliter
TESTO 1 SMX-S F UCH

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

  • B800TESTO1SFMC5 ()
  • B800TESTO1SFMC0 ()

  • Total Volume: 10 Milliliter
TESTO 1 S F MC

  • Multiple-type clinical chemistry analyte profile IVD, control
TESTOSTERONE 10 NG/DL
UTAK LABORATORIES, INC.
TESTO 10 V3 S F PG
In Commercial Distribution

  • B800TESTO10V3SFPG5 ()
  • B800TESTO10V3SFPG0 ()

  • Total Volume: 5 Milliliter
TESTO 10 V3 S F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
TESTOSTERONE 100 NG/DL
UTAK LABORATORIES, INC.
TESTO 100 V3 S F PG
In Commercial Distribution

  • B800TESTO100V3SFPG5 ()
  • B800TESTO100V3SFPG0 ()

  • Total Volume: 5 Milliliter
TESTO 100 V3 S F PG

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

  • B800TEPA3V2DPFMSKCC5 ()
  • B800TEPA3V2DPFMSKCC0 ()

  • Total Volume: 0.5 Milliliter
TEPA+ 3 V2 DP F MSKCC

  • Multiple-type clinical chemistry analyte profile IVD, control
TEPA3DPFMSKCC
UTAK LABORATORIES, INC.
TEPA+ 3 DP F MSKCC
In Commercial Distribution

  • B800TEPA3DPFMSKCC5 ()
  • B800TEPA3DPFMSKCC0 ()

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

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

  • B800TEPA2V2DPFMSKCC5 ()
  • B800TEPA2V2DPFMSKCC0 ()

  • Total Volume: 0.5 Milliliter
TEPA+ 2 V2 DP F MSKCC

  • Multiple-type clinical chemistry analyte profile IVD, control
TEPA2DPFMSKCC
UTAK LABORATORIES, INC.
TEPA+ 2 DP F MSKCC
In Commercial Distribution

  • B800TEPA2DPFMSKCC5 ()
  • B800TEPA2DPFMSKCC0 ()

  • Total Volume: 0.5 Milliliter
TEPA+ 2 DP F MSKCC

  • Multiple-type clinical chemistry analyte profile IVD, control
TEPA1DPFMSKCC
UTAK LABORATORIES, INC.
TEPA+ 1 DP F MSKCC
In Commercial Distribution

  • B800TEPA1DPFMSKCC5 ()
  • B800TEPA1DPFMSKCC0 ()

  • Total Volume: 0.5 Milliliter
TEPA+ 1 DP F MSKCC

  • Multiple-type clinical chemistry analyte profile IVD, control
TCA PANEL
UTAK LABORATORIES, INC.
TCA U F NMS
In Commercial Distribution

  • B800TCAUFNMS5 ()
  • B800TCAUFNMS0 ()

  • Total Volume: 0.3 Milliliter
TCA U F NMS

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

  • B800TCAQC5 ()
  • B800TCAQC0 ()

  • Total Volume: 25 Milliliter
TCA QC

  • Multiple-type clinical chemistry analyte profile IVD, control
TRICYCLICS LEVEL 2 V4
UTAK LABORATORIES, INC.
TCA L2 V4 S MAYO
In Commercial Distribution

  • B800TCAL2V4SMAYO5 ()
  • B800TCAL2V4SMAYO0 ()

  • Total Volume: 1 Milliliter
TCA L2 V4 S MAYO

  • Multiple drugs of abuse IVD, control
TAPENTADOL PLUS LEVEL 3
UTAK LABORATORIES, INC.
TAP+ 3 SMXU F PG
In Commercial Distribution

  • B800TAP3SMXUFPG5 ()
  • B800TAP3SMXUFPG0 ()

  • Total Volume: 2 Milliliter
TAP+ 3 SMXU F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
TAPENTADOL PLUS LEVEL 2
UTAK LABORATORIES, INC.
TAP+ 2 SMXU F PG
In Commercial Distribution

  • B800TAP2SMXUFPG5 ()
  • B800TAP2SMXUFPG0 ()

  • Total Volume: 2 Milliliter
TAP+ 2 SMXU F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
TAPENTADOL PLUS LEVEL 1
UTAK LABORATORIES, INC.
TAP+ 1 SMXU F PG
In Commercial Distribution

  • B800TAP1SMXUFPG5 ()
  • B800TAP1SMXUFPG0 ()

  • Total Volume: 2 Milliliter
TAP+ 1 SMXU F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
SULFAMETHOXAZOLE PLUS LEVEL 3
UTAK LABORATORIES, INC.
SUL+ 3 V3 MAYO
In Commercial Distribution

  • B800SUL3V3MAYO5 ()
  • B800SUL3V3MAYO0 ()

  • Total Volume: .5 Milliliter
SUL+ 3 V3 MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
SULFAMETHOXAZOLE PLUS LEVEL 2
UTAK LABORATORIES, INC.
SUL+ 2 V3 MAYO
In Commercial Distribution

  • B800SUL2V3MAYO5 ()
  • B800SUL2V3MAYO0 ()

  • Total Volume: .5 Milliliter
SUL+ 2 V3 MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
SULFAMETHOXAZOLE PLUS LEVEL 1
UTAK LABORATORIES, INC.
SUL+ 1 V3 MAYO
In Commercial Distribution

  • B800SUL1V3MAYO5 ()
  • B800SUL1V3MAYO0 ()

  • Total Volume: .5 Milliliter
SUL+ 1 V3 MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
STEROIDS MID
UTAK LABORATORIES, INC.
STER M S F SHC
In Commercial Distribution

  • B800STERMSFSHC5 ()
  • B800STERMSFSHC0 ()

  • Total Volume: 1 Milliliter
STER M S F SHC

  • Multiple-type clinical chemistry analyte profile IVD, control
STEROIDS LOW
UTAK LABORATORIES, INC.
STER L S F SHC
In Commercial Distribution

  • B800STERLSFSHC5 ()
  • B800STERLSFSHC0 ()

  • Total Volume: 1 Milliliter
STER L S F SHC

  • Multiple-type clinical chemistry analyte profile IVD, control
STEROIDS HIGH
UTAK LABORATORIES, INC.
STER H S F SHC
In Commercial Distribution

  • B800STERHSFSHC5 ()
  • B800STERHSFSHC0 ()

  • Total Volume: 1 Milliliter
STER H S F SHC

  • Multiple-type clinical chemistry analyte profile IVD, control
ENDO LEVEL 3
UTAK LABORATORIES, INC.
STER 3 SMXS F SRL
In Commercial Distribution

  • B800STER3SMXSFSRL5 ()
  • B800STER3SMXSFSRL0 ()

  • Total Volume: 3 Milliliter
STER 3 SMXS F SRL

  • Multiple-type clinical chemistry analyte profile IVD, control
ENDO LEVEL 2
UTAK LABORATORIES, INC.
STER 2 SMXS F SRL
In Commercial Distribution

  • B800STER2SMXSFSRL5 ()
  • B800STER2SMXSFSRL0 ()

  • Total Volume: 3 Milliliter
STER 2 SMXS F SRL

  • Multiple-type clinical chemistry analyte profile IVD, control
ENDO LEVEL 1
UTAK LABORATORIES, INC.
STER 1 SMXS F SRL
In Commercial Distribution

  • B800STER1SMXSFSRL5 ()
  • B800STER1SMXSFSRL0 ()

  • Total Volume: 3 Milliliter
STER 1 SMXS F SRL

  • Multiple-type clinical chemistry analyte profile IVD, control
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 SMX-VH F OCMEO
In Commercial Distribution

  • B800SPIRITS3SMXVHFOCME5 ()
  • B800SPIRITS3SMXVHFOCME0 ()

  • Total Volume: 5 Milliliter
SPIRITS 3 SMX-VH 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 WB F OCMEO
In Commercial Distribution

  • B800SPIRITS2WBFOCMEO5 ()
  • B800SPIRITS2WBFOCMEO0 ()

  • Total Volume: 5 Milliliter
SPIRITS 2 WB 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 SMX-VH F OCMEO
In Commercial Distribution

  • B800SPIRITS2SMXVHFOCME5 ()
  • B800SPIRITS2SMXVHFOCME0 ()

  • Total Volume: 5 Milliliter
SPIRITS 2 SMX-VH 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 WB F OCMEO
In Commercial Distribution

  • B800SPIRITS1WBFOCMEO5 ()
  • B800SPIRITS1WBFOCMEO0 ()

  • Total Volume: 5 Milliliter
SPIRITS 1 WB F OCMEO

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

  • B800SPIRITS1UFOCMEO5 ()
  • B800SPIRITS1UFOCMEO0 ()

  • Total Volume: 5 Milliliter
SPIRITS 1 U 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 50 F ABB
In Commercial Distribution

  • B800SMXWB50FABB5 ()
  • B800SMXWB50FABB0 ()

  • Total Volume: 50 Milliliter
SMX-WB 50 F ABB

  • 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.
SMX-U 10 F UPMC
In Commercial Distribution

  • B800SMXU10FUPMC5 ()
  • B800SMXU10FUPMC0 ()

  • Total Volume: 10 Milliliter
SMX-U 10 F UPMC

  • 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
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