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 4
UTAK LABORATORIES, INC.
LEAD 4 WB F LGC
In Commercial Distribution

  • B800LEAD4WBFLGC5 ()
  • B800LEAD4WBFLGC0 ()

  • Total Volume: 5 Milliliter
LEAD 4 WB F LGC

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 4 V3
UTAK LABORATORIES, INC.
LEAD 4 V3 WB F CH
In Commercial Distribution

  • B800LEAD4V3WBFCH0 ()

  • Total Volume: 0.5 Milliliter
LEAD 4 V3 WB F CH

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

  • B800LEAD3WBFUMMC5 ()
  • B800LEAD3WBFUMMC0 ()

  • Total Volume: 10 Milliliter
LEAD 3 WB F UMMC

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

  • B800LEAD3WBFUCI0 ()

  • Total Volume: 3 Milliliter
LEAD 3 WB F UCI

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

  • B800LEAD3WBFLGC5 ()
  • B800LEAD3WBFLGC0 ()

  • Total Volume: 5 Milliliter
LEAD 3 WB F LGC

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

  • B800LEAD3WBFBCH5 ()
  • B800LEAD3WBFBCH0 ()

  • Total Volume: 5 Milliliter
LEAD 3 WB F BCH

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 3 V4
UTAK LABORATORIES, INC.
LEAD 3 V4 WB F CH
In Commercial Distribution

  • B800LEAD3V4WBFCH5 ()
  • B800LEAD3V4WBFCH0 ()

  • Total Volume: 0.5 Milliliter
LEAD 3 V4 WB F CH

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 3 V3
UTAK LABORATORIES, INC.
LEAD 3 V3 WB F CH
In Commercial Distribution

  • B800LEAD3V3WBFCH5 ()
  • B800LEAD3V3WBFCH0 ()

  • Total Volume: 0.5 Milliliter
LEAD 3 V3 WB F CH

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD 30 UG/DL
UTAK LABORATORIES, INC.
LEAD 30 F WB NEPM
In Commercial Distribution

  • B800LEAD30FWBNEPM5 ()
  • B800LEAD30FWBNEPM0 ()

  • Total Volume: 2 Milliliter
LEAD 30 F WB NEPM

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

  • B800LEAD2WBFUMMC5 ()
  • B800LEAD2WBFUMMC0 ()

  • Total Volume: 10 Milliliter
LEAD 2 WB F UMMC

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

  • B800LEAD2WBFUCI5 ()
  • B800LEAD2WBFUCI0 ()

  • Total Volume: 3 Milliliter
LEAD 2 WB F UCI

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

  • B800LEAD2WBFLGC5 ()
  • B800LEAD2WBFLGC0 ()

  • Total Volume: 5 Milliliter
LEAD 2 WB F LGC

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

  • B800LEAD2WBFBCH5 ()
  • B800LEAD2WBFBCH0 ()

  • Total Volume: 5 Milliliter
LEAD 2 WB F BCH

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD 2 V4 WB F CH
UTAK LABORATORIES, INC.
LEAD LEVEL 2 V4
In Commercial Distribution

  • B800LEAD2V4WBFCH5 ()
  • B800LEAD2V4WBFCH0 ()

  • Total Volume: 0.5 Milliliter
LEAD LEVEL 2 V4

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 2 V3
UTAK LABORATORIES, INC.
LEAD 2 V3 WB F CH
In Commercial Distribution

  • B800LEAD2V3WBFCH5 ()
  • B800LEAD2V3WBFCH0 ()

  • Total Volume: 0.5 Milliliter
LEAD 2 V3 WB F CH

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

  • B800LEAD1WBFUMMC5 ()
  • B800LEAD1WBFUMMC0 ()

  • Total Volume: 10 Milliliter
LEAD 1 WB F UMMC

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

  • B800LEAD1WBFUCI5 ()
  • B800LEAD1WBFUCI0 ()

  • Total Volume: 3 Milliliter
LEAD 1 WB F UCI

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

  • B800LEAD1WBFLGC5 ()
  • B800LEAD1WBFLGC0 ()

  • Total Volume: 5 Milliliter
LEAD 1 WB F LGC

  • Multiple-type clinical chemistry analyte profile IVD, control
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
LAMOTRIGINE PLUS LEVEL 3
UTAK LABORATORIES, INC.
LAMO+ 3 V3 S UCH
In Commercial Distribution

  • B800LAMO3V3SUCH5 ()
  • B800LAMO3V3SUCH0 ()

  • Total Volume: 1.5 Milliliter
LAMO+ 3 V3 S UCH

  • Multiple drugs of abuse IVD, control
LAMOTRIGINE LEVEL 3
UTAK LABORATORIES, INC.
LAMO 3 S F UC
In Commercial Distribution

  • B800LAMO3SFUCI5 ()
  • B800LAMO3SFUCI0 ()

  • Total Volume: 3 Milliliter
LAMO 3 S F UC

  • Multiple-type clinical chemistry analyte profile IVD, control
LAMOTRIGINE PLUS LEVEL 2
UTAK LABORATORIES, INC.
LAMO+ 2 V3 S UCH
In Commercial Distribution

  • B800LAMO2V3SUCH5 ()
  • B800LAMO2V3SUCH0 ()

  • Total Volume: 1.5 Milliliter
LAMO+ 2 V3 S UCH

  • Multiple drugs of abuse IVD, control
LAMOTRIGINE LEVEL 2
UTAK LABORATORIES, INC.
LAMO 2 S F UCI
In Commercial Distribution

  • B800LAMO2SFUCI5 ()
  • B800LAMO2SFUCI0 ()

  • Total Volume: 17 Milliliter
LAMO 2 S F UCI

  • Multiple-type clinical chemistry analyte profile IVD, control
LAMOTRIGINE PLUS LEVEL 1
UTAK LABORATORIES, INC.
LAMO+ 1 V3 S UCHLAMO+ 1 V3 S UCH
In Commercial Distribution

  • B800LAMO1V3SUCH5 ()
  • B800LAMO1V3SUCH0 ()

  • Total Volume: 1.5 Milliliter
LAMO+ 1 V3 S UCH

  • Multiple drugs of abuse IVD, control
LAMOTRIGINE LEVEL 1
UTAK LABORATORIES, INC.
LAMO 1 S F UCI
In Commercial Distribution

  • B800LAMO1SFUCI5 ()
  • B800LAMO1SFUCI0 ()

  • Total Volume: 3 Milliliter
LAMO 1 S F UCI

  • Multiple-type clinical chemistry analyte profile IVD, control
KIT DAU V4
UTAK LABORATORIES, INC.
KIT DAU V4 POTM
In Commercial Distribution

  • B800KITDAUV4POTM5 ()
  • B800KITDAUV4POTM0 ()

  • Total Volume: 20 Milliliter
KIT DAU V4 POTM

  • 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
KIT DAU
UTAK LABORATORIES, INC.
KIT DAU POTM
In Commercial Distribution

  • B800KITDAUPOTM5 ()
  • B800KITDAUPOTM0 ()

  • Total Volume: 20 Milliliter
KIT DAU 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 CONTROL 1 V2
UTAK LABORATORIES, INC.
ISA+ CONT 1 V2 S F UCSF
In Commercial Distribution

  • B800ISACONT1V2SFUCSF5 ()
  • B800ISACONT1V2SFUCSF0 ()

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

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

  • B800ISACAL6V2SFUCSF5 ()
  • B800ISACAL6V2SFUCSF0 ()

  • Total Volume: 1 Milliliter
ISA+ CAL 6 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
ISAVUCONAZOLE PLUS CALIBRATOR 3
UTAK LABORATORIES, INC.
ISA+ CAL 3 S F UCSF
In Commercial Distribution

  • B800ISACAL3SFUCSF5 ()
  • B800ISACAL3SFUCSF0 ()

  • Total Volume: 0.5 Milliliter
ISA+ CAL 3 S F UCSF

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

  • B800ISACAL2V2SFUCSF5 ()
  • B800ISACAL2V2SFUCSF0 ()

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

  • Multiple-type clinical chemistry analyte profile IVD, control
ISAVUCONAZOLE PLUS CALIBRATOR 1
UTAK LABORATORIES, INC.
ISA+ CAL 1 S F UCSF
In Commercial Distribution

  • B800ISACAL1SFUCSF5 ()
  • B800ISACAL1SFUCSF0 ()

  • Total Volume: 0.5 Milliliter
ISA+ CAL 1 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
IODINE QC LEVEL 3
UTAK LABORATORIES, INC.
IOD QC 3 U QDVA
In Commercial Distribution

  • B800IODQC3UQDVA0 ()

  • Total Volume: 5 Milliliter
IOD QC 3 U QDVA

  • Multiple-type clinical chemistry analyte profile IVD, control
IODINE QC LEVEL 2
UTAK LABORATORIES, INC.
IOD QC 2 U QDVA
In Commercial Distribution

  • B800IODQC2UQDVA5 ()
  • B800IODQC2UQDVA0 ()

  • Total Volume: 5 Milliliter
IOD QC 2 U QDVA

  • Multiple-type clinical chemistry analyte profile IVD, control
IODINE QC LEVEL 1
UTAK LABORATORIES, INC.
IOD QC 1 U QDVA
In Commercial Distribution

  • B800IODQC1UQDVA5 ()
  • B800IODQC1UQDVA0 ()

  • Total Volume: 5 Milliliter
IOD QC 1 U QDVA

  • Multiple-type clinical chemistry analyte profile IVD, control
IODINE LEVEL 3
UTAK LABORATORIES, INC.
IOD 3 S F SQ
In Commercial Distribution

  • B800IOD3SFSQ5 ()
  • B800IOD3SFSQ0 ()

  • Total Volume: 3 Milliliter
IOD 3 S F SQ

  • Multiple-type clinical chemistry analyte profile IVD, control
IODINE LEVEL 2
UTAK LABORATORIES, INC.
IOD 2 S F SQ
In Commercial Distribution

  • B800IOD2SFSQ5 ()
  • B800IOD2SFSQ0 ()

  • Total Volume: 3 Milliliter
IOD 2 S F SQ

  • Multiple-type clinical chemistry analyte profile IVD, control
IODINE LEVEL 1
UTAK LABORATORIES, INC.
IOD 1 S F SQ
In Commercial Distribution

  • B800IOD1SFSQ5 ()
  • B800IOD1SFSQ0 ()

  • Total Volume: 3 Milliliter
IOD 1 S F SQ

  • Multiple-type clinical chemistry analyte profile IVD, control
INFLIXIMAB LEVEL 2
UTAK LABORATORIES, INC.
INFLIX QC 2 UPHS
In Commercial Distribution

  • B800INFLIXQC2UPHS5 ()
  • B800INFLIXQC2UPHS0 ()

  • Total Volume: 1 Milliliter
INFLIX QC 2 UPHS

  • Multiple-type clinical chemistry analyte profile IVD, control
GABAPENTIN PLUS
UTAK LABORATORIES, INC.
GABA+ V V2 WB F MSP
In Commercial Distribution

  • B800GABAVV2WBFMSP5 ()
  • B800GABAVV2WBFMSP0 ()

  • Total Volume: 50 Milliliter
GABA+ V V2 WB F MSP

  • Multiple drugs of abuse IVD, control
GABAPENTIN LEVEL 3 V2
UTAK LABORATORIES, INC.
GABA 3 V2 SMXU F PG
In Commercial Distribution

  • B800GABA3V2SMXUFPG5 ()
  • B800GABA3V2SMXUFPG0 ()

  • Total Volume: 2 Milliliter
GABA 3 V2 SMXU F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
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