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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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LEAD LEVEL 1
UTAK LABORATORIES, INC.
LEAD 1 WB F BCH
In Commercial Distribution

  • B800LEAD1WBFBCH5 ()
  • B800LEAD1WBFBCH0 ()

  • Total Volume: 5 Milliliter
LEAD 1 WB F BCH

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 1
UTAK LABORATORIES, INC.
LEAD 1 V2 WB F CH
In Commercial Distribution

  • B800LEAD1V2WBFCH5 ()
  • B800LEAD1V2WBFCH0 ()

  • Total Volume: 0.5 Milliliter
LEAD 1 V2 WB F CH

  • Multiple-type clinical chemistry analyte profile IVD, control
KIT DAU
UTAK LABORATORIES, INC.
KIT DAU V2 POTM
In Commercial Distribution

  • B800KITDAUV2POTM5 ()

  • Total Volume: 20 Milliliter
KIT DAU V2 POTM

  • Multiple-type clinical chemistry analyte profile IVD, control
ISAVUCONAZOLE PLUS CONTROL 3 V2
UTAK LABORATORIES, INC.
ISA+ CONT 3 V2 S F UCSF
In Commercial Distribution

  • B800ISACONT3V2SFUCSF5 ()
  • B800ISACONT3V2SFUCSF0 ()

  • Total Volume: 1 Milliliter
ISA+ CONT 3 V2 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ISAVUCONAZOLE PLUS CONTROL 2 V2
UTAK LABORATORIES, INC.
ISA+ CONT 2 V2 S F UCSF
In Commercial Distribution

  • B800ISACONT2V2SFUCSF5 ()
  • B800ISACONT2V2SFUCSF0 ()

  • Total Volume: 1 Milliliter
ISA+ CONT 2 V2 S F UCSF

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

  • B800ISACAL5V2SFUCSF5 ()
  • B800ISACAL5V2SFUCSF0 ()

  • Total Volume: 1 Milliliter
ISA+ CAL 5 V2 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
SAVUCONAZOLE PLUS CALIBRATOR 5
UTAK LABORATORIES, INC.
ISA+ CAL 5 S F UCSF
In Commercial Distribution

  • B800ISACAL5SFUCSF5 ()
  • B800ISACAL5SFUCSF0 ()

  • Total Volume: 0.5 Milliliter
ISA+ CAL 5 S F UCSF

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

  • B800ISACAL4V2SFUCSF5 ()
  • B800ISACAL4V2SFUCSF0 ()

  • Total Volume: 1 Milliliter
ISA+ CAL 4 V2 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ISAVUCONAZOLE PLUS CALIBRATOR 4
UTAK LABORATORIES, INC.
ISA+ CAL 4 S F UCSF
In Commercial Distribution

  • B800ISACAL4SFUCSF5 ()
  • B800ISACAL4SFUCSF0 ()

  • Total Volume: 0.5 Milliliter
ISA+ CAL 4 S F UCSF

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

  • B800ISACAL3V2SFUCSF5 ()
  • B800ISACAL3V2SFUCSF0 ()

  • Total Volume: 1 Milliliter
ISA+ CAL 3 V2 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
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