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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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BUTALBITAL PLUS 3 V2
UTAK LABORATORIES, INC.
BUTALBITAL+ 3 V2 AP
In Commercial Distribution

  • B800BUTALBITAL3V2AP5 ()
  • B800BUTALBITAL3V2AP0 ()

  • Total Volume: 10 Milliliter
BUTALBITAL+ 3 V2 AP

  • Multiple-type clinical chemistry analyte profile IVD, control
BUTALBITAL PLUS 2 V2
UTAK LABORATORIES, INC.
BUTALBITAL+ 2 V2 AP
In Commercial Distribution

  • B800BUTALBITAL2V2AP5 ()
  • B800BUTALBITAL2V2AP0 ()

  • Total Volume: 10 Milliliter
BUTALBITAL+ 2 V2 AP

  • Multiple-type clinical chemistry analyte profile IVD, control
BUTALBITAL PLUS 1 V2
UTAK LABORATORIES, INC.
BUTALBITAL+ 1 V2 AP
In Commercial Distribution

  • B800BUTALBITAL1V2AP5 ()
  • B800BUTALBITAL1V2AP0 ()

  • Total Volume: 10 Milliliter
BUTALBITAL+ 1 V2 AP

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN QC LEVEL 3
UTAK LABORATORIES, INC.
BUS QC 3 F SHP BHM
In Commercial Distribution

  • B800BUSQC3FSHPBHM5 ()
  • B800BUSQC3FSHPBHM0 ()

  • Total Volume: 2 Milliliter
BUS QC 3 F SHP BHM

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN QC LEVEL 2
UTAK LABORATORIES, INC.
BUS QC 2 P F URMC
In Commercial Distribution

  • B800BUSQC2PFURMC5 ()
  • B800BUSQC2PFURMC0 ()

  • Total Volume: 5 Milliliter
BUS QC 2 P F URMC

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN QC LEVEL 2
UTAK LABORATORIES, INC.
BUS QC 2 F SHP BHM
In Commercial Distribution

  • B800BUSQC2FSHPBHM5 ()
  • B800BUSQC2FSHPBHM0 ()

  • Total Volume: 2 Milliliter
BUS QC 2 F SHP BHM

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN QC LEVEL 1
UTAK LABORATORIES, INC.
BUS QC 1 P F URMC
In Commercial Distribution

  • B800BUSQC1PFURMC5 ()
  • B800BUSQC1PFURMC0 ()

  • Total Volume: 5 Milliliter
BUS QC 1 P F URMC

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN LEVEL 1
UTAK LABORATORIES, INC.
BUS QC 1 F CMH
In Commercial Distribution

  • B800BUSQC1FCMH5 ()
  • B800BUSQC1FCMH0 ()

  • Total Volume: 3 Milliliter
BUS QC 1 F CMH

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN MID
UTAK LABORATORIES, INC.
BUS M SP F TCH
In Commercial Distribution

  • B800BUSMSPFTCH5 ()
  • B800BUSMSPFTCH0 ()

  • Total Volume: 5 Milliliter
BUS M SP F TCH

  • Multiple-therapy therapeutic drug monitoring IVD, control
BUSULFAN LOW
UTAK LABORATORIES, INC.
BUS L SP F TCH
In Commercial Distribution

  • B800BUSLSPFTCH5 ()
  • B800BUSLSPFTCH0 ()

  • Total Volume: 5 Milliliter
BUS L SP F TCH

  • Multiple-therapy therapeutic drug monitoring IVD, control
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