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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CODEINE-6-B-D-GLUCURONIDE PLUS
UTAK LABORATORIES, INC.
COD GLUC+ U F DS
In Commercial Distribution

  • B800CODGLUCUFDS5 ()
  • B800CODGLUCUFDS0 ()

  • Total Volume: 2.2 Milliliter
COD GLUC+ U F DS

  • Multiple-therapy therapeutic drug monitoring IVD, control
CODEINE GLUC PLUS LEVEL 2
UTAK LABORATORIES, INC.
COD GLUC+ 2 U F YNHH
In Commercial Distribution

  • B800CODGLUC2UFYNHH5 ()
  • B800CODGLUC2UFYNHH0 ()

  • Total Volume: 2.6 Milliliter
COD GLUC+ 2 U F YNHH

  • Multiple-type clinical chemistry analyte profile IVD, control
CODEINE GLUC PLUS LEVEL 1
UTAK LABORATORIES, INC.
COD GLUC+ 1 U F YNHH
In Commercial Distribution

  • B800CODGLUC1UFYNHH5 ()
  • B800CODGLUC1UFYNHH0 ()

  • Total Volume: 2.6 Milliliter
COD GLUC+ 1 U F YNHH

  • Multiple-type clinical chemistry analyte profile IVD, control
COCAMPH
UTAK LABORATORIES, INC.
COCAMPH M TCAU
In Commercial Distribution

  • B800COCAMPHMTCAU5 ()
  • B800COCAMPHMTCAU0 ()

  • Total Volume: 50 Milliliter
COCAMPH M TCAU

  • Multiple-type clinical chemistry analyte profile IVD, control
CLOZAPINE PLUS
UTAK LABORATORIES, INC.
CLOZ+ S AQ
In Commercial Distribution

  • B800CLOZSAQ5 ()
  • B800CLOZSAQ0 ()

  • Total Volume: 5 Milliliter
CLOZ+ S AQ

  • Multiple-type clinical chemistry analyte profile IVD, control
CLINICAL HIGH V4
UTAK LABORATORIES, INC.
CLIN H V4 F BPC
In Commercial Distribution

  • B800CLINHV4FBPC5 ()
  • B800CLINHV4FBPC0 ()

  • Total Volume: 2 Milliliter
CLIN H V4 F BPC

  • Multiple drugs of abuse IVD, control
CHROMIUM PLUS LEVEL 2
UTAK LABORATORIES, INC.
CHROM+ 2 WB QD
In Commercial Distribution

  • B800CHROM2WBQD5 ()
  • B800CHROM2WBQD0 ()

  • Total Volume: 5 Milliliter
CHROM+ 2 WB QD

  • Multiple-type clinical chemistry analyte profile IVD, control
CHROMIUM PLUS LEVEL 1
UTAK LABORATORIES, INC.
CHROM+ 1 WB QD
In Commercial Distribution

  • B800CHROM1WBQD5 ()
  • B800CHROM1WBQD0 ()

  • Total Volume: 5 Milliliter
CHROM+ 1 WB QD

  • Multiple-type clinical chemistry analyte profile IVD, control
CERTIFIED DRUG URINE
UTAK LABORATORIES, INC.
CDF U F 500 OHSU
In Commercial Distribution

  • B800CDFUF500OHSU0 ()

  • Total Volume: 500 Milliliter
CDF U F 500 OHSU

  • Multiple-type clinical chemistry analyte profile IVD, control
CERTIFIED DRUG FREE URINE
UTAK LABORATORIES, INC.
CDF U F 400 CL
In Commercial Distribution

  • B800CDFUF400CL0 ()

  • Total Volume: 400 Milliliter
CDF U F 400 CL

  • Multiple-type clinical chemistry analyte profile IVD, control
CERTIFIED DRUG FREE URINE
UTAK LABORATORIES, INC.
CDF U F 10 NJSP
In Commercial Distribution

  • B800CDFUF10NJSP5 ()
  • B800CDFUF10NJSP0 ()

  • Total Volume: 10 Milliliter
CDF U F 10 NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN 25 NG/ML
UTAK LABORATORIES, INC.
BUS 25 V P F CHLA
In Commercial Distribution

  • B800BUS25VPFCHLA5 ()
  • B800BUS25VPFCHLA0 ()
  • B800BUS25VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 25 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control
BUS 250 V P F CHLA
UTAK LABORATORIES, INC.
BUS 250 V P F CHLA
In Commercial Distribution

  • B800BUS250VPFCHLA5 ()
  • B800BUS250VPFCHLA0 ()
  • B800BUS250VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 250 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control
BUS 250 DP MSKCC
UTAK LABORATORIES, INC.
BUS 250 DP MSKCC
In Commercial Distribution

  • B800BUS250DPMSKCC5 ()
  • B800BUS250DPMSKCC0 ()

  • Total Volume: .5 Milliliter
BUS 250 DP MSKCC

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN LEVEL 1 V2
UTAK LABORATORIES, INC.
BUS 1 V2 P F EBS UK
In Commercial Distribution

  • B800BUS1V2PFEBSUK5 ()
  • B800BUS1V2PFEBSUK0 ()

  • Total Volume: 3 Milliliter
BUS 1 V2 P F EBS UK

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

  • B800BUS1PFNIH5 ()
  • B800BUS1PFNIH0 ()

  • Total Volume: 1 Milliliter
BUS 1 P F NIH

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

  • B800BUS1PFEBSUK5 ()
  • B800BUS1PFEBSUK0 ()

  • Total Volume: 3 Milliliter
BUS 1 P F EBS UK

  • Multiple drugs of abuse IVD, control
BUSULFAN LEVEL 1
UTAK LABORATORIES, INC.
BUS 1 DP UPMC
In Commercial Distribution

  • B800BUS1DPUPMC5 ()
  • B800BUS1DPUPMC0 ()

  • Total Volume: 0.5 Milliliter
BUS 1 DP UPMC

  • Multiple-therapy therapeutic drug monitoring IVD, control
BUSULFAN LEVEL 1
UTAK LABORATORIES, INC.
BUS 1 DP F DU
In Commercial Distribution

  • B800BUS1DPFDU5 ()
  • B800BUS1DPFDU0 ()

  • Total Volume: 1 Milliliter
BUS 1 DP F DU

  • Multiple-therapy therapeutic drug monitoring IVD, control
BUSULFAN 1750 NG/ML
UTAK LABORATORIES, INC.
BUS 1750 LP UCSF
In Commercial Distribution

  • B800BUS1750LPUCSF5 ()
  • B800BUS1750LPUCSF0 ()

  • Total Volume: 0.5 Milliliter
BUS 1750 LP UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
BUS1700HUP
UTAK LABORATORIES, INC.
BUS 1700 HUP
In Commercial Distribution

  • B800BUS1700HUP5 ()
  • B800BUS1700HUP0 ()

  • Total Volume: 5 Milliliter
BUS 1700 HUP

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN 10 NG/ML
UTAK LABORATORIES, INC.
BUS 10 V P F CHLA
In Commercial Distribution

  • B800BUS10VPFCHLA5 ()
  • B800BUS10VPFCHLA0 ()
  • B800BUS10VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 10 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN 100 NG/ML
UTAK LABORATORIES, INC.
BUS 100 V P F CHLA
In Commercial Distribution

  • B800BUS100VPFCHLA5 ()
  • B800BUS100VPFCHLA0 ()
  • B800BUS100VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 100 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control
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 2
UTAK LABORATORIES, INC.
BUP+ QC 2 U TRL
In Commercial Distribution

  • B800BUPQC2UTRL5 ()
  • B800BUPQC2UTRL0 ()

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

  • 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 MID
UTAK LABORATORIES, INC.
BUP+ M SMXU F PATH
In Commercial Distribution

  • B800BUPMSMXUFPATH5 ()
  • B800BUPMSMXUFPATH0 ()

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

  • 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 PLUS HIGH
UTAK LABORATORIES, INC.
BUP+ H SMXU F PATH
In Commercial Distribution

  • B800BUPHSMXUFPATH5 ()
  • B800BUPHSMXUFPATH0 ()

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

  • 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 4
UTAK LABORATORIES, INC.
BUP+ 4 U KP
In Commercial Distribution

  • B800BUP4UKP5 ()
  • B800BUP4UKP0 ()

  • Total Volume: 1 Milliliter
BUP+ 4 U KP

  • Multiple therapeutic drugs/drugs of abuse IVD, control
BUPRENORPHINE PLUS LEVEL 3 V2
UTAK LABORATORIES, INC.
BUP+ 3 V2 U F MAYO
In Commercial Distribution

  • B800BUP3V2UFMAYO5 ()
  • B800BUP3V2UFMAYO0 ()

  • Total Volume: 1 Milliliter
BUP+ 3 V2 U F MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
BUPRENORPHINE PLUS LEVEL 3
UTAK LABORATORIES, INC.
BUP+ 3 U KP
In Commercial Distribution

  • B800BUP3UKP5 ()
  • B800BUP3UKP0 ()

  • Total Volume: 1 Milliliter
BUP+ 3 U KP

  • Multiple therapeutic drugs/drugs of abuse IVD, control
BUPRENORPHINE PLUS LEVEL 2 V2
UTAK LABORATORIES, INC.
BUP+ 2 V2 U KP
In Commercial Distribution

  • B800BUP2V2UKP5 ()
  • B800BUP2V2UKP0 ()

  • Total Volume: 1 Milliliter
BUP+ 2 V2 U KP

  • Multiple drugs of abuse 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
BENZODIAZEPINES QC V4
UTAK LABORATORIES, INC.
BENZO QC V4 FCCO
In Commercial Distribution

  • B800BENZOQCV4FCCO5 ()
  • B800BENZOQCV4FCCO0 ()

  • Total Volume: 25 Milliliter
BENZO QC V4 FCCO

  • Multiple-type clinical chemistry analyte profile IVD, control
BENZODIAZEPINES LEVEL 2 V3
UTAK LABORATORIES, INC.
BENZO L2 V3 U F UW
In Commercial Distribution

  • B800BENZOL2V3UFUW5 ()
  • B800BENZOL2V3UFUW0 ()

  • Total Volume: 0.75 Milliliter
BENZO L2 V3 U F UW

  • Multiple-type clinical chemistry analyte profile IVD, control
BENZODIAZEPINES LEVEL 2 V2
UTAK LABORATORIES, INC.
BENZO L2 V2 U F UW
In Commercial Distribution

  • B800BENZOL2V2UFUW5 ()
  • B800BENZOL2V2UFUW0 ()

  • Total Volume: 1 Milliliter
BENZO L2 V2 U F UW

  • Multiple-type clinical chemistry analyte profile IVD, control
BENZODIAZEPINES LEVEL 2
UTAK LABORATORIES, INC.
BENZO L2 U F UW
In Commercial Distribution

  • B800BENZOL2UFUW5 ()
  • B800BENZOL2UFUW0 ()

  • Total Volume: 1 Milliliter
BENZO L2 U F UW

  • Multiple-type clinical chemistry analyte profile IVD, control
BENZODIAZEPINES LEVEL 1 V3
UTAK LABORATORIES, INC.
BENZO L1 V3 U F UW
In Commercial Distribution

  • B800BENZOL1V3UFUW5 ()
  • B800BENZOL1V3UFUW0 ()

  • Total Volume: 0.75 Milliliter
BENZO L1 V3 U F UW

  • Multiple-type clinical chemistry analyte profile IVD, control
BENZODIAZEPINES LEVEL 1 V2
UTAK LABORATORIES, INC.
BENZO L1 V2 U F UW
In Commercial Distribution

  • B800BENZOL1V2UFUW5 ()
  • B800BENZOL1V2UFUW0 ()

  • Total Volume: 1 Milliliter
BENZO L1 V2 U F UW

  • Multiple-type clinical chemistry analyte profile IVD, control
BENZODIAZEPINES LEVEL 1
UTAK LABORATORIES, INC.
BENZO L1 U F UW
In Commercial Distribution

  • B800BENZOL1UFUW0 ()

  • Total Volume: 1 Milliliter
BENZO L1 U F UW

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTIPSYCH+ V3 OF F OT
UTAK LABORATORIES, INC.
ORAL FLUID UTAK
In Commercial Distribution

  • B800ANTIPSYCHV3OFFOT5 ()
  • B800ANTIPSYCHV3OFFOT0 ()

  • Total Volume: 1 Milliliter
ORAL FLUID UTAK

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTIPSYCHOTICS URINE PLUS
UTAK LABORATORIES, INC.
ANTIPSYCH+ V2 U F OT
In Commercial Distribution

  • B800ANTIPSYCHV2UFOT5 ()
  • B800ANTIPSYCHV2UFOT0 ()

  • Total Volume: 1 Milliliter
ANTIPSYCH+ V2 U F OT

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTIHISTAMINES PLUS
UTAK LABORATORIES, INC.
ANTIHIST+ S F NMS
In Commercial Distribution

  • B800ANTIHISTSFNMS5 ()
  • B800ANTIHISTSFNMS0 ()

  • Total Volume: 5 Milliliter
ANTIHIST+ S F NMS

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTIFUNGAL QC LEVEL 3
UTAK LABORATORIES, INC.
ANTIF QC 3 V2 LP F TF
In Commercial Distribution

  • B800ANTIFQC3V2LPFTF5 ()
  • B800ANTIFQC3V2LPFTF0 ()

  • Total Volume: 1 Milliliter
ANTIF QC 3 V2 LP F TF

  • Multiple-therapy therapeutic drug monitoring IVD, control
ANTIFUNGAL QC LEVEL 2
UTAK LABORATORIES, INC.
ANTIF QC 2 V2 LP F TF
In Commercial Distribution

  • B800ANTIFQC2V2LPFTF5 ()
  • B800ANTIFQC2V2LPFTF0 ()

  • Total Volume: 1 Milliliter
ANTIF QC 2 V2 LP F TF

  • Multiple-therapy therapeutic drug monitoring IVD, control
ANTIFUNGAL QC LEVEL 1
UTAK LABORATORIES, INC.
ANTIF QC 1 V2 LP F TF
In Commercial Distribution

  • B800ANTIFQC1V2LPFTF5 ()
  • B800ANTIFQC1V2LPFTF0 ()

  • Total Volume: 1 Milliliter
ANTIF QC 1 V2 LP F TF

  • Multiple-therapy therapeutic drug monitoring IVD, control
ANTIFUNGALS LEVEL 3 V3
UTAK LABORATORIES, INC.
ANTIF 3 V3 F UVHS
In Commercial Distribution

  • B800ANTIF3V3FUVHS5 ()
  • B800ANTIF3V3FUVHS0 ()

  • Total Volume: 10 Milliliter
ANTIF 3 V3 F UVHS

  • Multiple-type clinical chemistry analyte profile IVD, control
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