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 CAL 2000 NG/ML
UTAK LABORATORIES, INC.
BUS CAL 2000 UCSF
In Commercial Distribution

  • B800BUSCAL2000UCSF0 ()

  • Total Volume: 0.5 Milliliter
BUS CAL 2000 UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN CALIBRATOR LEVEL 1 V2
UTAK LABORATORIES, INC.
BUS CAL 1 V2 DP F MDACC
In Commercial Distribution

  • B800BUSCAL1V2DPFMDACC5 ()
  • B800BUSCAL1V2DPFMDACC0 ()

  • Total Volume: 1.5 Milliliter
BUS CAL 1 V2 DP F MDACC

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN CALIBRATOR LEVEL 1
UTAK LABORATORIES, INC.
BUS CAL 1 SJCR
In Commercial Distribution

  • B800BUSCAL1SJCR5 ()
  • B800BUSCAL1SJCR0 ()

  • Total Volume: 5 Milliliter
BUS CAL 1 SJCR

  • Multiple drugs of abuse IVD, control
BUSULFAN CALIBRATOR 1
UTAK LABORATORIES, INC.
BUS CAL 1 P F URMC
In Commercial Distribution

  • B800BUSCAL1PFURMC5 ()
  • B800BUSCAL1PFURMC0 ()

  • Total Volume: 10 Milliliter
BUS CAL 1 P F URMC

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN CAL 1000 NG/ML
UTAK LABORATORIES, INC.
BUS CAL 1000 UCSF
In Commercial Distribution

  • B800BUSCAL1000UCSF5 ()
  • B800BUSCAL1000UCSF0 ()

  • Total Volume: 0.5 Milliliter
BUS CAL 1000 UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN CAL 0 NG/ML
UTAK LABORATORIES, INC.
BUS CAL 0 UCSF
In Commercial Distribution

  • B800BUSCAL0UCSF5 ()
  • B800BUSCAL0UCSF0 ()

  • Total Volume: 0.5 Milliliter
BUS CAL 0 UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN LEVEL 4
UTAK LABORATORIES, INC.
BUS C4 MAYO
In Commercial Distribution

  • B800BUSC4MAYO0 ()
  • B800BUSC4MAYO5 ()

  • Total Volume: .3 Milliliter
BUS C4 MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN LEVEL 3
UTAK LABORATORIES, INC.
BUS C3 MAYO
In Commercial Distribution

  • B800BUSC3MAYO5 ()
  • B800BUSC3MAYO0 ()

  • Total Volume: .3 Milliliter
BUS C3 MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN LEVEL 2
UTAK LABORATORIES, INC.
BUS C2 MAYO
In Commercial Distribution

  • B800BUSC2MAYO5 ()
  • B800BUSC2MAYO0 ()

  • Total Volume: .3 Milliliter
BUS C2 MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN LEVEL 1
UTAK LABORATORIES, INC.
BUS C1 MAYO
In Commercial Distribution

  • B800BUSC1MAYO0 ()
  • B800BUSC1MAYO5 ()

  • Total Volume: .3 Milliliter
BUS C1 MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
BUS 900 DP MSKCC
UTAK LABORATORIES, INC.
BUS 900 DP MSKCC
In Commercial Distribution

  • B800BUS900DPMSKCC0 ()
  • B800BUS900DPMSKCC5 ()

  • Total Volume: .5 Milliliter
BUS 900 DP MSKCC

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN 500 NG/ML
UTAK LABORATORIES, INC.
BUS 500 LP UCSF
In Commercial Distribution

  • B800BUS500LPUCSF5 ()
  • B800BUS500LPUCSF0 ()

  • Total Volume: 0.5 Milliliter
BUS 500 LP UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN 5000 NG/ML
UTAK LABORATORIES, INC.
BUS 5000 V P F CHLA
In Commercial Distribution

  • B800BUS5000VPFCHLA0 ()
  • B800BUS5000VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 5000 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN LEVEL 4
UTAK LABORATORIES, INC.
BUS 4 V DP F DU
In Commercial Distribution

  • B800BUS4VDPFDU5 ()
  • B800BUS4VDPFDU0 ()

  • Total Volume: 1 Milliliter
BUS 4 V DP F DU

  • Multiple-therapy therapeutic drug monitoring IVD, control
BUSULFAN LEVEL 3 V2
UTAK LABORATORIES, INC.
BUS 3 V2 P F EBS UK
In Commercial Distribution

  • B800BUS3V2PFEBSUK0 ()
  • B800BUS3V2PFEBSUK5 ()

  • Total Volume: 3 Milliliter
BUS 3 V2 P F EBS UK

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

  • B800BUS3PFNIH5 ()
  • B800BUS3PFNIH0 ()

  • Total Volume: 1 Milliliter
BUS 3 P F NIH

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN LEVEL 3
UTAK LABORATORIES, INC.
BUS 3 P F EBS UK
In Commercial Distribution

  • B800BUS3PFEBSUK5 ()
  • B800BUS3PFEBSUK0 ()

  • Total Volume: 3 Milliliter
BUS 3 P F EBS UK

  • Multiple drugs of abuse IVD, control
BUSULFAN LEVEL 3
UTAK LABORATORIES, INC.
BUS 3 DP UPMC
In Commercial Distribution

  • B800BUS3DPUPMC5 ()
  • B800BUS3DPUPMC0 ()

  • Total Volume: 0.5 Milliliter
BUS 3 DP UPMC

  • Multiple-therapy therapeutic drug monitoring IVD, control
BUSULFAN LEVEL 3
UTAK LABORATORIES, INC.
BUS 3 DP F DU
In Commercial Distribution

  • B800BUS3DPFDU5 ()
  • B800BUS3DPFDU0 ()

  • Total Volume: 1 Milliliter
BUS 3 DP F DU

  • Multiple-therapy therapeutic drug monitoring IVD, control
BUS350HUP
UTAK LABORATORIES, INC.
BUS 350 HUP
In Commercial Distribution

  • B800BUS350HUP5 ()
  • B800BUS350HUP0 ()

  • Total Volume: 5 Milliliter
BUS 350 HUP

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN 3500 NG/ML
UTAK LABORATORIES, INC.
BUS 3500 P F BCH
In Commercial Distribution

  • B800BUS3500PFBCH5 ()
  • B800BUS3500PFBCH0 ()

  • Total Volume: 3 Milliliter
BUS 3500 P F BCH

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN 3500 NG/ML
UTAK LABORATORIES, INC.
BUS 3500 LP UCSF
In Commercial Distribution

  • B800BUS3500LPUCSF5 ()
  • B800BUS3500LPUCSF0 ()

  • Total Volume: 0.5 Milliliter
BUS 3500 LP UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN 3500 UG/L
UTAK LABORATORIES, INC.
BUS 3500 HUP
In Commercial Distribution

  • B800BUS3500HUP5 ()
  • B800BUS3500HUP0 ()

  • Total Volume: 5 Milliliter
BUS 3500 HUP

  • Multiple-type clinical chemistry analyte profile IVD, control
BUS 3500 DP MSKCC
UTAK LABORATORIES, INC.
BUS 3500 DP MSKCC
In Commercial Distribution

  • B800BUS3500DPMSKCC0 ()
  • B800BUS3500DPMSKCC5 ()

  • Total Volume: .5 Milliliter
BUS 3500 DP MSKCC

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN LEVEL 2 V2
UTAK LABORATORIES, INC.
BUS 2 V2 P F EBS UK
In Commercial Distribution

  • B800BUS2V2PFEBSUK5 ()
  • B800BUS2V2PFEBSUK0 ()

  • Total Volume: 3 Milliliter
BUS 2 V2 P F EBS UK

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

  • B800BUS2PFNIH5 ()
  • B800BUS2PFNIH0 ()

  • Total Volume: 1 Milliliter
BUS 2 P F NIH

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

  • B800BUS2PFEBSUK5 ()
  • B800BUS2PFEBSUK0 ()

  • Total Volume: 3 Milliliter
BUS 2 P F EBS UK

  • Multiple drugs of abuse IVD, control
BUSULFAN LEVEL 2
UTAK LABORATORIES, INC.
BUS 2 DP UPMC
In Commercial Distribution

  • B800BUS2DPUPMC5 ()
  • B800BUS2DPUPMC0 ()

  • Total Volume: 0.5 Milliliter
BUS 2 DP UPMC

  • Multiple-therapy therapeutic drug monitoring IVD, control
BUSULFAN LEVEL 2
UTAK LABORATORIES, INC.
BUS 2 DP F DU
In Commercial Distribution

  • B800BUS2DPFDU5 ()
  • B800BUS2DPFDU0 ()

  • Total Volume: 1 Milliliter
BUS 2 DP F DU

  • Multiple-therapy therapeutic drug monitoring 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 V2
UTAK LABORATORIES, INC.
BUP+ 1 V2 U F MAYO
In Commercial Distribution

  • B800BUP1V2UFMAYO5 ()
  • B800BUP1V2UFMAYO0 ()

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

  • Multiple-type clinical chemistry analyte profile 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
BUPRENORPHINE PLUS LEVEL 1
UTAK LABORATORIES, INC.
BUP+ 1 U F FML
In Commercial Distribution

  • B800BUP1UFFML5 ()
  • B800BUP1UFFML0 ()

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

  • Multiple 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 NJSP
In Commercial Distribution

  • B800BLKWBNJSP0 ()

  • Total Volume: 10 Milliliter
BLK WB NJSP

  • 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
BLANK SERUM
UTAK LABORATORIES, INC.
BLK S NC
In Commercial Distribution

  • B800BLKSNC5 ()
  • B800BLKSNC0 ()

  • Total Volume: 2 Milliliter
BLK S NC

  • Multiple-type clinical chemistry analyte profile IVD, control
BLANK HAIR MATRIX
UTAK LABORATORIES, INC.
BLK HAIR OL
In Commercial Distribution

  • B800BLKHAIROL0 ()
  • B800BLKHAIROL5 ()

  • Total Volume: 100 Milliliter
BLK HAIR OL

  • Multiple therapeutic drugs/drugs of abuse IVD, control
BENZU UNCOMMON PATH QC 2
UTAK LABORATORIES, INC.
BENZU NCP PATH QC 2 V3
In Commercial Distribution

  • B800BENZUNCPPATHQC2V30 ()
  • B800BENZUNCPPATHQC2V35 ()

  • Total Volume: 1.2 Milliliter
BENZU NCP PATH QC 2 V3

  • Multiple-type clinical chemistry analyte profile IVD, control
BENZODIAZEPINES
UTAK LABORATORIES, INC.
BENZ U F KP
In Commercial Distribution

  • B800BENZUFKP5 ()
  • B800BENZUFKP0 ()

  • Total Volume: 20 Milliliter
BENZ U F KP

  • 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
BENZOYLECGONINE LEVEL 2
UTAK LABORATORIES, INC.
BENZOYL 2 F APTC
In Commercial Distribution

  • B800BENZOYL2FAPTC5 ()
  • B800BENZOYL2FAPTC0 ()

  • Total Volume: 10 Milliliter
BENZOYL 2 F APTC

  • Multiple drugs of abuse IVD, control
BENZOYLECGONINE LEVEL 1
UTAK LABORATORIES, INC.
BENZOYL 1 F APTC
In Commercial Distribution

  • B800BENZOYL1FAPTC5 ()
  • B800BENZOYL1FAPTC0 ()

  • Total Volume: 10 Milliliter
BENZOYL 1 F APTC

  • Multiple drugs of abuse IVD, control
BENZOYLECGONINE 700 NG/ML
UTAK LABORATORIES, INC.
BENZOY 700 U F APS
In Commercial Distribution

  • B800BENZOY700UFAPS5 ()
  • B800BENZOY700UFAPS0 ()

  • Total Volume: 1 Milliliter
BENZOY 700 U F APS

  • Multiple drugs of abuse IVD, control
BENZODIAZEPINES 150 NG/ML
UTAK LABORATORIES, INC.
BENZO 150 U F QDPA
In Commercial Distribution

  • B800BENZO150UFQDPA5 ()
  • B800BENZO150UFQDPA0 ()

  • Total Volume: 1 Milliliter
BENZO 150 U F QDPA

  • Multiple-type clinical chemistry analyte profile IVD, control
BASIC QC
UTAK LABORATORIES, INC.
BASIC QC
In Commercial Distribution

  • B800BASICQC5 ()
  • B800BASICQC0 ()

  • Total Volume: 25 Milliliter
BASIC QC

  • Multiple-type clinical chemistry analyte profile IVD, control
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