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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ANABASINE PLUS LEVEL 1 V2
UTAK LABORATORIES, INC.
ANAB+ 1 V2 U LC
In Commercial Distribution

  • B800ANAB1V2ULC5 ()
  • B800ANAB1V2ULC0 ()

  • Total Volume: 5 Milliliter
ANAB+ 1 V2 U LC

  • Multiple-type clinical chemistry analyte profile IVD, control
COTININE PLUS LEVEL 1 V2
UTAK LABORATORIES, INC.
COT+ 1 V2 S LC
In Commercial Distribution

  • B800COT1V2SLC5 ()
  • B800COT1V2SLC0 ()

  • Total Volume: 5 Milliliter
COT+ 1 V2 S LC

  • Multiple-type clinical chemistry analyte profile IVD, control
CLOZAPINE 500 NG/ML V2
UTAK LABORATORIES, INC.
CLOZ 500 V2 UCI
In Commercial Distribution

  • B800CLOZ500V2UCI5 ()
  • B800CLOZ500V2UCI0 ()

  • Total Volume: 5 Milliliter
CLOZ 500 V2 UCI

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN CALIBRATOR LEVEL 6 V2
UTAK LABORATORIES, INC.
BUS CAL 6 V2 DP F MDACC
In Commercial Distribution

  • B800BUSCAL6V2DPFMDACC5 ()
  • B800BUSCAL6V2DPFMDACC0 ()

  • Total Volume: 1.5 Milliliter
BUS CAL 6 V2 DP F MDACC

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN CALIBRATOR LEVEL 5 V2
UTAK LABORATORIES, INC.
BUS CAL 5 V2 DP F MDACC
In Commercial Distribution

  • B800BUSCAL5V2DPFMDACC5 ()
  • B800BUSCAL5V2DPFMDACC0 ()

  • Total Volume: 1.5 Milliliter
BUS CAL 5 V2 DP F MDACC

  • Multiple-type clinical chemistry analyte profile IVD, control
ARACHIDIC ACID LEVEL 2 V2
UTAK LABORATORIES, INC.
ARA+ 2 V2 S ID
In Commercial Distribution

  • B800ARA2V2SID5 ()
  • B800ARA2V2SID0 ()

  • Total Volume: 3 Milliliter
ARA+ 2 V2 S ID

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

  • B800AMIT2V2SSH5 ()
  • B800AMIT2V2SSH0 ()

  • Total Volume: 3 Milliliter
AMIT+ 2 V2 S SH

  • Multiple-type clinical chemistry analyte profile IVD, control
AMITRIPTYLINE PLUS LEVEL 1 V2
UTAK LABORATORIES, INC.
AMIT+ 1 V2 S SH
In Commercial Distribution

  • B800AMIT1V2SSH5 ()
  • B800AMIT1V2SSH0 ()

  • Total Volume: 3 Milliliter
AMIT+ 1 V2 S SH

  • Multiple-type clinical chemistry analyte profile IVD, control
NORMAL RANGE TRACE ELEMENTS V2
UTAK LABORATORIES, INC.
66816 NR V2 LC
In Commercial Distribution

  • B80066816NRV2LC5 ()
  • B80066816NRV2LC0 ()

  • Total Volume: 5 Milliliter
66816 NR V2 LC

  • Multiple-type clinical chemistry analyte profile IVD, control
HIGH RANGE TRACE ELEMENTS V2
UTAK LABORATORIES, INC.
66815 HR V2 LC
In Commercial Distribution

  • B80066815HRV2LC0 ()

  • Total Volume: 5 Milliliter
66815 HR V2 LC

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

  • B800DAUPOSV2FUPMC5 ()
  • B800DAUPOSV2FUPMC0 ()

  • Total Volume: 10 Milliliter
DAU POS V2 F UPMC

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

  • B800DAUMIDV2FPG5 ()
  • B800DAUMIDV2FPG0 ()

  • Total Volume: 2 Milliliter
DAU MID V2 F PG

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

  • B800DAULOWV2FPG5 ()
  • B800DAULOWV2FPG0 ()

  • Total Volume: 2 Milliliter
DAU LOW V2 F PG

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

  • B800DAUHIGHV2FPG5 ()
  • B800DAUHIGHV2FPG0 ()

  • Total Volume: 2 Milliliter
DAU HIGH V2 F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU B LEVEL 2 V2
UTAK LABORATORIES, INC.
DAU B 2 V2 F IHL
In Commercial Distribution

  • B800DAUB2V2FIHL5 ()
  • B800DAUB2V2FIHL0 ()

  • Total Volume: 10 Milliliter
DAU B 2 V2 F IHL

  • Multiple drugs of abuse IVD, control
DAU B LEVEL 1 V2
UTAK LABORATORIES, INC.
DAU B 1 V2 F IHL
In Commercial Distribution

  • B800DAUB1V2FIHL5 ()
  • B800DAUB1V2FIHL0 ()

  • Total Volume: 10 Milliliter
DAU B 1 V2 F IHL

  • Multiple drugs of abuse IVD, control
VOLATILES 400 MG/DL V2
UTAK LABORATORIES, INC.
VOL 400 WB F V2 HCMC
In Commercial Distribution

  • B800VOL400WBFV2HCMC5 ()
  • B800VOL400WBFV2HCMC0 ()

  • Total Volume: 3 Milliliter
VOL 400 WB F V2 HCMC

  • Multiple-type clinical chemistry analyte profile IVD, control
TRACE ELEMENTS LEVEL 3 V2
UTAK LABORATORIES, INC.
TRACE 3 V2 S QD
In Commercial Distribution

  • B800TRACE3V2SQD5 ()
  • B800TRACE3V2SQD0 ()

  • Total Volume: 5 Milliliter
TRACE 3 V2 S QD

  • Multiple-type clinical chemistry analyte profile IVD, control
TRACE ELEMENTS LEVEL 2 V2
UTAK LABORATORIES, INC.
TRACE 2 V2 S QD
In Commercial Distribution

  • B800TRACE2V2SQD5 ()
  • B800TRACE2V2SQD0 ()

  • Total Volume: 5 Milliliter
TRACE 2 V2 S QD

  • Multiple-type clinical chemistry analyte profile IVD, control
TRACE ELEMENTS LEVEL 1 V2
UTAK LABORATORIES, INC.
TRACE 1 V2 S QD
In Commercial Distribution

  • B800TRACE1V2SQD5 ()
  • B800TRACE1V2SQD0 ()

  • Total Volume: 5 Milliliter
TRACE 1 V2 S QD

  • Multiple-type clinical chemistry analyte profile IVD, control
THC PLUS LEVEL 4 V2
UTAK LABORATORIES, INC.
THC+ 4 U V2 NJSP
In Commercial Distribution

  • B800THC4UV2NJSP5 ()
  • B800THC4UV2NJSP0 ()

  • Total Volume: 5 Milliliter
THC+ 4 U V2 NJSP

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

  • B800THC3UV2NJSP5 ()
  • B800THC3UV2NJSP0 ()

  • Total Volume: 5 Milliliter
THC+ 3 U V2 NJSP

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

  • B800TEPA3V2DPFMSKCC5 ()
  • B800TEPA3V2DPFMSKCC0 ()

  • Total Volume: 0.5 Milliliter
TEPA+ 3 V2 DP F MSKCC

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

  • B800TEPA2V2DPFMSKCC5 ()
  • B800TEPA2V2DPFMSKCC0 ()

  • Total Volume: 0.5 Milliliter
TEPA+ 2 V2 DP F MSKCC

  • Multiple-type clinical chemistry analyte profile IVD, control
LEFLUNOMIDE V2 LOW LEVEL 3
UTAK LABORATORIES, INC.
LEFLU V2 L L3
In Commercial Distribution

  • B800LEFLUV2LL35 ()
  • B800LEFLUV2LL30 ()

  • Total Volume: .5 Milliliter
LEFLU V2 L L3

  • Multiple-type clinical chemistry analyte profile IVD, control
LEFLUNOMIDE V2 LOW LEVEL 2
UTAK LABORATORIES, INC.
LEFLU V2 L L2
In Commercial Distribution

  • B800LEFLUV2LL25 ()
  • B800LEFLUV2LL20 ()

  • Total Volume: .5 Milliliter
LEFLU V2 L L2

  • Multiple-type clinical chemistry analyte profile IVD, control
LEFLUNOMIDE V2 LOW LEVEL 1
UTAK LABORATORIES, INC.
LEFLU V2 L L1
In Commercial Distribution

  • B800LEFLUV2LL15 ()
  • B800LEFLUV2LL10 ()

  • Total Volume: .5 Milliliter
LEFLU V2 L L1

  • Multiple-type clinical chemistry analyte profile IVD, control
ISAVUCONAZOLE PLUS CONTROL 3 V2
UTAK LABORATORIES, INC.
ISA+ CONT 3 V2 S F UCSF
In Commercial Distribution

  • B800ISACONT3V2SFUCSF5 ()
  • B800ISACONT3V2SFUCSF0 ()

  • Total Volume: 1 Milliliter
ISA+ CONT 3 V2 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ISAVUCONAZOLE PLUS CONTROL 2 V2
UTAK LABORATORIES, INC.
ISA+ CONT 2 V2 S F UCSF
In Commercial Distribution

  • B800ISACONT2V2SFUCSF5 ()
  • B800ISACONT2V2SFUCSF0 ()

  • Total Volume: 1 Milliliter
ISA+ CONT 2 V2 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ISAVUCONAZOLE PLUS CONTROL 1 V2
UTAK LABORATORIES, INC.
ISA+ CONT 1 V2 S F UCSF
In Commercial Distribution

  • B800ISACONT1V2SFUCSF5 ()
  • B800ISACONT1V2SFUCSF0 ()

  • Total Volume: 1 Milliliter
ISA+ CONT 1 V2 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
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