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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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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
BLANK WHOLE BLOOD
UTAK LABORATORIES, INC.
BLK WB NC
In Commercial Distribution

  • B800BLKWBNC5 ()
  • B800BLKWBNC0 ()

  • Total Volume: 2 Milliliter
BLK WB NC

  • Multiple-type clinical chemistry analyte profile IVD, control
WHOLE BLOOD MATRIX
UTAK LABORATORIES, INC.
BLK WB F CH
In Commercial Distribution

  • B800BLKWBFCH5 ()
  • B800BLKWBFCH0 ()

  • Total Volume: 0.5 Milliliter
BLK WB F CH

  • Multiple-type clinical chemistry analyte profile IVD, control
CERTIFIED DRUG FREE URINE
UTAK LABORATORIES, INC.
BLK U F 100 MAKO
In Commercial Distribution

  • B800BLKUF100MAKO5 ()
  • B800BLKUF100MAKO0 ()

  • Total Volume: 10 Milliliter
BLK U F 100 MAKO

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
UTAK LABORATORIES, INC.
BENZU CP QC 2 V3
In Commercial Distribution

  • B800BENZUCPQC2V35 ()
  • B800BENZUCPQC2V30 ()

  • Total Volume: 1.2 Milliliter
BENZU CP QC 2 V3

  • Multiple-type clinical chemistry analyte profile IVD, control
BENZODIAZEPINES PLUS
UTAK LABORATORIES, INC.
BENZO+ U F TRL
In Commercial Distribution

  • B800BENZOUFTRL5 ()
  • B800BENZOUFTRL0 ()

  • Total Volume: 1 Milliliter
BENZO+ U F TRL

  • Multiple-type clinical chemistry analyte profile IVD, control
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