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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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LEFLUNOMIDE HIGH LEVEL 2
UTAK LABORATORIES, INC.
LEFLU HIGH L2 V2
In Commercial Distribution

  • B800LEFLUHIGHL2V25 ()
  • B800LEFLUHIGHL2V20 ()

  • Total Volume: 0.1 Milliliter
LEFLU HIGH L2 V2

  • Multiple drugs of abuse IVD, control
LEFLUNOMIDE HIGH LEVEL 2
UTAK LABORATORIES, INC.
LEFLU HIGH L2
In Commercial Distribution

  • B800LEFLUHIGHL25 ()
  • B800LEFLUHIGHL20 ()

  • Total Volume: 0.1 Milliliter
LEFLU HIGH L2

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

  • B800LAMO2SUPENN5 ()
  • B800LAMO2SUPENN0 ()

  • Total Volume: 5 Milliliter
LAMO+ 2 S UPENN

  • Multiple-therapy therapeutic drug monitoring 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
GHB 2 UG/ML
UTAK LABORATORIES, INC.
GHB 2 WB NJSP
In Commercial Distribution

  • B800GHB2WBNJSP0 ()

  • Total Volume: 5 Milliliter
GHB 2 WB NJSP

  • Multiple drugs of abuse IVD, control
FENTANYL PANEL POSITIVE 2
UTAK LABORATORIES, INC.
FENT+ POS2 U KP
In Commercial Distribution

  • B800FENTPOS2UKP5 ()
  • B800FENTPOS2UKP0 ()

  • Total Volume: 10 Microliter
FENT+ POS2 U KP

  • Multiple drugs of abuse IVD, control
FENTANYL CALIBRATOR LEVEL 2
UTAK LABORATORIES, INC.
FENT+ CAL 2 U F KP
In Commercial Distribution

  • B800FENTCAL2UFKP5 ()
  • B800FENTCAL2UFKP0 ()

  • Total Volume: 1 Milliliter
FENT+ CAL 2 U F KP

  • Multiple-type clinical chemistry analyte profile IVD, control
FENTANYL PLUS LEVEL 2
UTAK LABORATORIES, INC.
FENT+ 2 WB NJSP
In Commercial Distribution

  • B800FENT2WBNJSP5 ()
  • B800FENT2WBNJSP0 ()

  • Total Volume: 5 Milliliter
FENT+ 2 WB NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control
FENTANYL PLUS LEVEL 2
UTAK LABORATORIES, INC.
FENT+ 2 V2 U NJSP
In Commercial Distribution

  • B800FENT2V2UNJSP5 ()
  • B800FENT2V2UNJSP0 ()

  • Total Volume: 5 Milliliter
FENT+ 2 V2 U NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control
FENTANYL PLUS LEVEL 2
UTAK LABORATORIES, INC.
FENT+ 2 U QD
In Commercial Distribution

  • B800FENT2UQD5 ()
  • B800FENT2UQD0 ()

  • Total Volume: 20 Milliliter
FENT+ 2 U QD

  • Multiple drugs of abuse IVD, control
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