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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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ARSENIC PLUS LEVEL 1
UTAK LABORATORIES, INC.
ARSEN+ 1 U F LC
In Commercial Distribution

  • B800ARSEN1UFLC5 ()
  • B800ARSEN1UFLC0 ()

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

  • Multiple-type clinical chemistry analyte profile IVD, control
ORAL FLUID UTAK
UTAK LABORATORIES, INC.
ANTIPSYCH+ V4 OF F OT
In Commercial Distribution

  • B800ANTIPSYCHV4OFFOT5 ()
  • B800ANTIPSYCHV4OFFOT0 ()

  • Total Volume: 1 Milliliter
ANTIPSYCH+ V4 OF F OT

  • 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
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 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
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
AMIODARONE PLUS 3 UG/ML
UTAK LABORATORIES, INC.
AMIO+ 3 MAYO
In Commercial Distribution

  • B800AMIO3MAYO05 ()
  • B800AMIO3MAYO0 ()

  • Total Volume: 2.5 Milliliter
AMIO+ 3 MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
AMIODARONE LEVEL 1
UTAK LABORATORIES, INC.
AMIO 1 S F QDVA
In Commercial Distribution

  • B800AMIO1SFQDVA5 ()
  • B800AMIO1SFQDVA0 ()

  • Total Volume: 5 Milliliter
AMIO 1 S F QDVA

  • Multiple-type clinical chemistry analyte profile IVD, control
AMIODARONE PLUS 1 UG/ML
UTAK LABORATORIES, INC.
AMIO+ 1 MAYO
In Commercial Distribution

  • B800AMIO1MAYO0 ()

  • Total Volume: 2.5 Milliliter
AMIO+ 1 MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
ALPT23 ETOH 09
UTAK LABORATORIES, INC.
ALPT23_ETOH 09
In Commercial Distribution

  • B800ALPT23ETOH095 ()
  • B800ALPT23ETOH090 ()

  • Total Volume: 1.25 Milliliter
ALPT23_ETOH 09

  • Multiple-type clinical chemistry analyte profile IVD, control
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