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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IMMUNOSUPPRESSANTS LEVEL 3
UTAK LABORATORIES, INC.
IMMU 3 V2 WB F PH
In Commercial Distribution

  • B800IMMU3V2WBFPH5 ()
  • B800IMMU3V2WBFPH0 ()

  • Total Volume: 2 Milliliter
IMMU 3 V2 WB F PH

  • Multiple-type clinical chemistry analyte profile IVD, control
IMMUNOSUPPRESSANTS LEVEL 2
UTAK LABORATORIES, INC.
IMMU 2 V2 WB F PH
In Commercial Distribution

  • B800IMMU2V2WBFPH5 ()
  • B800IMMU2V2WBFPH0 ()
IMMU 2 V2 WB F PH

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
UTAK LABORATORIES, INC.
IMMU 1 V2 WB F PH
In Commercial Distribution

  • B800IMMU1V2WBFPH5 ()
  • B800IMMU1V2WBFPH0 ()

  • Total Volume: 2 Milliliter
IMMU 1 V2 WB F PH

  • Multiple-type clinical chemistry analyte profile IVD, control
GABAPENTIN PLUS
UTAK LABORATORIES, INC.
GABA+ V V2 WB F MSP
In Commercial Distribution

  • B800GABAVV2WBFMSP5 ()
  • B800GABAVV2WBFMSP0 ()

  • Total Volume: 50 Milliliter
GABA+ V V2 WB F MSP

  • Multiple drugs of abuse IVD, control
GABAPENTIN LEVEL 2
UTAK LABORATORIES, INC.
GABA 2 V2 SMXU F PG
In Commercial Distribution

  • B800GABA2V2SMXUFPG5 ()
  • B800GABA2V2SMXUFPG0 ()

  • Total Volume: 2.5 Milliliter
GABA 2 V2 SMXU F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS LEVEL 3
UTAK LABORATORIES, INC.
ETG+ 3 V2 U F CCL
In Commercial Distribution

  • B800ETG3V2UFCCL5 ()
  • B800ETG3V2UFCCL0 ()

  • Total Volume: 2 Milliliter
ETG+ 3 V2 U F CCL

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

  • B800ETG2V2UFCCL5 ()
  • B800ETG2V2UFCCL0 ()

  • Total Volume: 2 Milliliter
ETG+ 2 V2 U F CCL

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS LEVEL 1
UTAK LABORATORIES, INC.
ETG+ 1 V2 U F CCL
In Commercial Distribution

  • B800ETG1V2UFCCL5 ()
  • B800ETG1V2UFCCL0 ()

  • Total Volume: 2 Milliliter
ETG+ 1 V2 U F CCL

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE CAL LEVEL 2
UTAK LABORATORIES, INC.
DAU+ L LEVEL 2 V2 URMC
In Commercial Distribution

  • B800DAULLEVEL2V2URMC5 ()
  • B800DAULLEVEL2V2URMC0 ()

  • Total Volume: 5 Milliliter
DAU+ L LEVEL 2 V2 URMC

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE CAL LEVEL 1
UTAK LABORATORIES, INC.
DAU+ L LEVEL 1 V2 URMC
In Commercial Distribution

  • B800DAULLEVEL1V2URMC5 ()
  • B800DAULLEVEL1V2URMC0 ()

  • Total Volume: 5 Milliliter
DAU+ L LEVEL 1 V2 URMC

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE LEVEL 3
UTAK LABORATORIES, INC.
DAU 3 V2 F U VMG
In Commercial Distribution

  • B800DAU3V2FUVMG0 ()
  • B800DAU3V2FUVMG05 ()
  • B800DAU3V2FUVMG5 ()

  • Total Volume: 10 Milliliter
DAU 3 V2 F U VMG

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE LEVEL 2
UTAK LABORATORIES, INC.
DAU 2 V2 F U VMG
In Commercial Distribution

  • B800DAU2V2FUVMG5 ()
  • B800DAU2V2FUVMG0 ()

  • Total Volume: 10 Milliliter
DAU 2 V2 F U VMG

  • Multiple therapeutic drugs/drugs of abuse IVD, control
DRUGS OF ABUSE LEVEL 1
UTAK LABORATORIES, INC.
DAU 1 V2 F U VMG
In Commercial Distribution

  • B800DAU1V2FUVMG5 ()
  • B800DAU1V2FUVMG0 ()

  • Total Volume: 10 Milliliter
DAU 1 V2 F U VMG

  • Multiple drugs of abuse IVD, control
VORICONAZOLE PLUS 3
UTAK LABORATORIES, INC.
VOR+ 3 V2 S F UNC
In Commercial Distribution

  • B800VOR3V2SFUNC5 ()
  • B800VOR3V2SFUNC0 ()

  • Total Volume: 2 Milliliter
VOR+ 3 V2 S F UNC

  • Multiple-therapy therapeutic drug monitoring IVD, control
VORICONAZOLE PLUS 2
UTAK LABORATORIES, INC.
VOR+ 2 V2 S F UNC
In Commercial Distribution

  • B800VOR2V2SFUNC5 ()
  • B800VOR2V2SFUNC0 ()

  • Total Volume: 2 Milliliter
VOR+ 2 V2 S F UNC

  • Multiple-therapy therapeutic drug monitoring IVD, control
VORICONAZOLE PLUS 1
UTAK LABORATORIES, INC.
VOR+ 1 V2 S F UNC
In Commercial Distribution

  • B800VOR1V2SFUNC5 ()
  • B800VOR1V2SFUNC0 ()

  • Total Volume: 2 Milliliter
VOR+ 1 V2 S F UNC

  • Multiple-therapy therapeutic drug monitoring IVD, control
TESTOSTERONE 7.5 NG/DL
UTAK LABORATORIES, INC.
TESTO 7.5 V2 S F LCMS
In Commercial Distribution

  • B800TESTO75V2SFLCMS5 ()
  • B800TESTO75V2SFLCMS0 ()

  • Total Volume: 1.1 Milliliter
TESTO 7.5 V2 S F LCMS

  • Multiple-type clinical chemistry analyte profile IVD, control
VOLATILES LEVEL 2
UTAK LABORATORIES, INC.
VOL 2 V2 S F RIH
In Commercial Distribution

  • B800VOL2V2SFRIH5 ()
  • B800VOL2V2SFRIH0 ()

  • Total Volume: 5 Milliliter
VOL 2 V2 S F RIH

  • Multiple drugs of abuse IVD, control
VOLATILES LEVEL 1
UTAK LABORATORIES, INC.
VOL 1 V2 S F RIH
In Commercial Distribution

  • B800VOL1V2SFRIH5 ()
  • B800VOL1V2SFRIH0 ()

  • Total Volume: 5 Milliliter
VOL 1 V2 S F RIH

  • Multiple drugs of abuse IVD, control
PETH LEVEL 3
UTAK LABORATORIES, INC.
PETH 3 V2 WB F MAYO
In Commercial Distribution

  • B800PETH3V2WBFMAYO5 ()
  • B800PETH3V2WBFMAYO0 ()

  • Total Volume: 1 Milliliter
PETH 3 V2 WB F MAYO

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

  • B800OXAGLUCV2UFHCMC5 ()
  • B800OXAGLUCV2UFHCMC0 ()

  • Total Volume: 2 Milliliter
OXA GLUC V2 U F HCMC

  • Multiple drugs of abuse IVD, control
LEAD LEVEL 1
UTAK LABORATORIES, INC.
LEAD 1 V2 WB V WDL
In Commercial Distribution

  • B800LEAD1V2WBVWDL5 ()
  • B800LEAD1V2WBVWDL0 ()

  • Total Volume: 15 Milliliter
LEAD 1 V2 WB V WDL

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 1
UTAK LABORATORIES, INC.
LEAD 1 V2 WB F CH
In Commercial Distribution

  • B800LEAD1V2WBFCH5 ()
  • B800LEAD1V2WBFCH0 ()

  • Total Volume: 0.5 Milliliter
LEAD 1 V2 WB F CH

  • Multiple-type clinical chemistry analyte profile IVD, control
ETHYLENE GLYCOL LEVEL 2
UTAK LABORATORIES, INC.
ETHGLY 2 V2 S F RIH
In Commercial Distribution

  • B800ETHGLY2V2SFRIH0 ()
  • B800ETHGLY2V2SFRIH5 ()

  • Total Volume: 5 Milliliter
ETHGLY 2 V2 S F RIH

  • Ethylene glycol IVD, control
DRUGS OF ABUSE QC 3
UTAK LABORATORIES, INC.
DAU QC 3 V2 F BILH
In Commercial Distribution

  • B800DAUQC3V2FBILH5 ()
  • B800DAUQC3V2FBILH0 ()

  • Total Volume: 2 Milliliter
DAU QC 3 V2 F BILH

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE QC 1
UTAK LABORATORIES, INC.
DAU QC 1 V2 F BILH
In Commercial Distribution

  • B800DAUQC1V2FBILH5 ()
  • B800DAUQC1V2FBILH0 ()

  • Total Volume: 2 Milliliter
DAU QC 1 V2 F BILH

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE POSITIVE
UTAK LABORATORIES, INC.
DAU POS V2 U F PHHC
In Commercial Distribution

  • B800DAUPOSV2UFPHHC5 ()
  • B800DAUPOSV2UFPHHC0 ()

  • Total Volume: 3 Milliliter
DAU POS V2 U F PHHC

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LOW
UTAK LABORATORIES, INC.
DA LOW V2 WB F BTL
In Commercial Distribution

  • B800DALOWV2WBFBTL5 ()
  • B800DALOWV2WBFBTL0 ()

  • Total Volume: 1 Milliliter
DA LOW V2 WB F BTL

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE HIGH
UTAK LABORATORIES, INC.
DA HIGH V2 WB F BTL
In Commercial Distribution

  • B800DAHIGHV2WBFBTL5 ()
  • B800DAHIGHV2WBFBTL0 ()

  • Total Volume: 1 Milliliter
DA HIGH V2 WB F BTL

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE CUTOFF
UTAK LABORATORIES, INC.
DA CUT V2 S F PL
In Commercial Distribution

  • B800DACUTV2SFPL5 ()
  • B800DACUTV2SFPL0 ()

  • Total Volume: 5 Milliliter
DA CUT V2 S F PL

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LEVEL 2
UTAK LABORATORIES, INC.
DA 2 V2 F WB TDHS
In Commercial Distribution

  • B800DA2V2FWBTDHS5 ()
  • B800DA2V2FWBTDHS0 ()

  • Total Volume: 5 Milliliter
DA 2 V2 F WB TDHS

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE LEVEL 1
UTAK LABORATORIES, INC.
DA 1 V2 F WB TDHS
In Commercial Distribution

  • B800DA1V2FWBTDHS5 ()
  • B800DA1V2FWBTDHS0 ()

  • Total Volume: 5 Milliliter
DA 1 V2 F WB TDHS

  • Multiple drugs of abuse IVD, control
COPPER PLUS LEVEL 2
UTAK LABORATORIES, INC.
COP+ 2 V2 S F UW
In Commercial Distribution

  • B800COP2V2SFUW5 ()
  • B800COP2V2SFUW0 ()

  • Total Volume: 5 Milliliter
COP+ 2 V2 S F UW

  • Multiple-type clinical chemistry analyte profile IVD, control
COPPER PLUS LEVEL 1
UTAK LABORATORIES, INC.
COP+ 1 V2 S F UW
In Commercial Distribution

  • B800COP1V2SFUW5 ()
  • B800COP1V2SFUW0 ()

  • Total Volume: 5 Milliliter
COP+ 1 V2 S F UW

  • Multiple-type clinical chemistry analyte profile IVD, control
CODEINE GLUCURONIDE PLUS LEVEL 2
UTAK LABORATORIES, INC.
COD GLUC+ 2 V2 U PM
In Commercial Distribution

  • B800CODGLUC2V2UPM5 ()
  • B800CODGLUC2V2UPM0 ()

  • Total Volume: 3 Milliliter
COD GLUC+ 2 V2 U PM

  • Multiple-type clinical chemistry analyte profile IVD, control
CODEINE GLUCURONIDE PLUS LEVEL 1
UTAK LABORATORIES, INC.
COD GLUC+ 1 V2 U PM
In Commercial Distribution

  • B800CODGLUC1V2UPM5 ()
  • B800CODGLUC1V2UPM0 ()

  • Total Volume: 3 Milliliter
COD GLUC+ 1 V2 U PM

  • Multiple-type clinical chemistry analyte profile IVD, control
CLOBAZAM PLUS LEVEL 3
UTAK LABORATORIES, INC.
CLOB+ 3 V2 S F MAYO
In Commercial Distribution

  • B800CLOB3V2SFMAYO5 ()
  • B800CLOB3V2SFMAYO0 ()

  • Total Volume: .5 Milliliter
CLOB+ 3 V2 S F MAYO

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

  • B800CLOB2V2SFMAYO0 ()
  • B800CLOB2V2SFMAYO5 ()

  • Total Volume: .5 Milliliter
CLOB+ 2 V2 S F MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
CLOBAZAM PLUS LEVEL 1
UTAK LABORATORIES, INC.
CLOB+ 1 V2 S F MAYO
In Commercial Distribution

  • B800CLOB1V2SFMAYO5 ()
  • B800CLOB1V2SFMAYO0 ()

  • Total Volume: .5 Milliliter
CLOB+ 1 V2 S F MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
CCDKMQC2V2WBUK
UTAK LABORATORIES, INC.
CCDKM QC 2 V2 WB UK
In Commercial Distribution

  • B800CCDKMQC2V2WBUK5 ()
  • B800CCDKMQC2V2WBUK0 ()

  • Total Volume: 3 Milliliter
CCDKM QC 2 V2 WB UK

  • Multiple-type clinical chemistry analyte profile IVD, control
ARSENIC PLUS LEVEL 3
UTAK LABORATORIES, INC.
ARSEN+ 3 V2 U F LC
In Commercial Distribution

  • B800ARSEN3V2UFLC5 ()
  • B800ARSEN3V2UFLC0 ()

  • Total Volume: 2 Milliliter
ARSEN+ 3 V2 U F LC

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

  • B800ARSEN2V2UFLC5 ()
  • B800ARSEN2V2UFLC0 ()

  • Total Volume: 2 Milliliter
ARSEN+ 2 V2 U F LC

  • Multiple-type clinical chemistry analyte profile IVD, control
ARSENIC PLUS LEVEL 1
UTAK LABORATORIES, INC.
ARSEN+ 1 V2 U F LC
In Commercial Distribution

  • B800ARSEN1V2UFLC5 ()
  • B800ARSEN1V2UFLC0 ()

  • Total Volume: 2 Milliliter
ARSEN+ 1 V2 U F LC

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

  • B800AMIT2V2UFTRL5 ()
  • B800AMIT2V2UFTRL0 ()

  • Total Volume: 1 Milliliter
AMIT+ 2 V2 U F TRL

  • Multiple-type clinical chemistry analyte profile IVD, control
ALPRAZOLAM PLUS LEVEL 3
UTAK LABORATORIES, INC.
ALP+ 3 V2 U F UK
In Commercial Distribution

  • B800ALP3V2UFUK5 ()
  • B800ALP3V2UFUK0 ()

  • Total Volume: 2 Milliliter
ALP+ 3 V2 U F UK

  • Multiple-type clinical chemistry analyte profile IVD, control
ALPRAZOLAM PLUS LEVEL 3
UTAK LABORATORIES, INC.
ALP+ 3 V2 U F LENCO
In Commercial Distribution

  • B800ALP3V2UFLENCO5 ()
  • B800ALP3V2UFLENCO0 ()

  • Total Volume: 2.5 Milliliter
ALP+ 3 V2 U F LENCO

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

  • B800ALP2V2UFUK5 ()
  • B800ALP2V2UFUK0 ()

  • Total Volume: 2 Milliliter
ALP+ 2 V2 U F UK

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

  • B800ALP2V2UFLENCO5 ()
  • B800ALP2V2UFLENCO0 ()

  • Total Volume: 2.5 Milliliter
ALP+ 2 V2 U F LENCO

  • Multiple-type clinical chemistry analyte profile IVD, control
ALPRAZOLAM PLUS LEVEL 1
UTAK LABORATORIES, INC.
ALP+ 1 V2 U F UK
In Commercial Distribution

  • B800ALP1V2UFUK5 ()
  • B800ALP1V2UFUK0 ()

  • Total Volume: 2 Milliliter
ALP+ 1 V2 U F UK

  • Multiple-type clinical chemistry analyte profile IVD, control
ALPRAZOLAM PLUS LEVEL 1
UTAK LABORATORIES, INC.
ALP+ 1 V2 U F LENCO
In Commercial Distribution

  • B800ALP1V2UFLENCO5 ()
  • B800ALP1V2UFLENCO0 ()

  • Total Volume: 2.5 Milliliter
ALP+ 1 V2 U F LENCO

  • Multiple-type clinical chemistry analyte profile IVD, control
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