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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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BUSULFAN 1000 NG/ML
UTAK LABORATORIES, INC.
BUS 1000 V P F CHLA
In Commercial Distribution

  • B800BUS1000VPFCHLA5 ()
  • B800BUS1000VPFCHLA0 ()
  • B800BUS1000VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 1000 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control
BUPRENORPHINE PLUS QC LEVEL 1
UTAK LABORATORIES, INC.
BUP+ QC 1 U TRL
In Commercial Distribution

  • B800BUPQC1UTRL5 ()
  • B800BUPQC1UTRL0 ()

  • Total Volume: 2 Milliliter
BUP+ QC 1 U TRL

  • Multiple-type clinical chemistry analyte profile IVD, control
BUPRENORPHINE PLUS LOW
UTAK LABORATORIES, INC.
BUP+ L SMXU F PATH
In Commercial Distribution

  • B800BUPLSMXUFPATH5 ()
  • B800BUPLSMXUFPATH0 ()

  • Total Volume: 2 Milliliter
BUP+ L SMXU F PATH

  • Multiple-type clinical chemistry analyte profile IVD, control
BUPRENORPHINE PLUS LOW
UTAK LABORATORIES, INC.
BUP+ LOW U KP
In Commercial Distribution

  • B800BUPLOWUKP5 ()
  • B800BUPLOWUKP0 ()

  • Total Volume: 1 Milliliter
BUP+ LOW U KP

  • Multiple-type clinical chemistry analyte profile IVD, control
BUPRENORPHINE GLUCURONIDE V2
UTAK LABORATORIES, INC.
BUP GLUC+ QC V2 U F HCMC
In Commercial Distribution

  • B800BUPGLUCQCV2UFHCMC5 ()
  • B800BUPGLUCQCV2UFHCMC0 ()

  • Total Volume: 2 Milliliter
BUP GLUC+ QC V2 U F HCMC

  • Multiple-type clinical chemistry analyte profile IVD, control
BUPRENORPHINE PLUS LEVEL 2 V2
UTAK LABORATORIES, INC.
BUP+ 2 V2 U F MAYO
In Commercial Distribution

  • B800BUP2V2UFMAYO5 ()
  • B800BUP2V2UFMAYO0 ()

  • Total Volume: 1 Milliliter
BUP+ 2 V2 U F MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
BUPRENORPHINE PLUS LEVEL 2
UTAK LABORATORIES, INC.
BUP+ 2 U KP
In Commercial Distribution

  • B800BUP2UKP5 ()
  • B800BUP2UKP0 ()

  • Total Volume: 1 Milliliter
BUP+ 2 U KP

  • Multiple therapeutic drugs/drugs of abuse IVD, control
BUPRENORPHINE PLUS LEVEL 2
UTAK LABORATORIES, INC.
BUP+ 2 U F FML
In Commercial Distribution

  • B800BUP2UFFML5 ()
  • B800BUP2UFFML0 ()

  • Total Volume: 1 Milliliter
BUP+ 2 U F FML

  • Multiple drugs of abuse IVD, control
BUPRENORPHINE PLUS LEVEL 1
UTAK LABORATORIES, INC.
BUP+ 1 U KP
In Commercial Distribution

  • B800BUP1UKP5 ()
  • B800BUP1UKP0 ()

  • Total Volume: 1 Milliliter
BUP+ 1 U KP

  • Multiple therapeutic drugs/drugs of abuse IVD, control
BSIM QC
UTAK LABORATORIES, INC.
BSIM QC
In Commercial Distribution

  • B800BSIMQC5 ()
  • B800BSIMQC0 ()

  • Total Volume: 25 Milliliter
BSIM QC

  • Multiple-type clinical chemistry analyte profile IVD, control
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