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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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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
ANTIFUNGALS LEVEL 3 V2
UTAK LABORATORIES, INC.
ANTIF 3 V2 F UVHS
In Commercial Distribution

  • B800ANTIF3V2FUVHS5 ()
  • B800ANTIF3V2FUVHS0 ()

  • Total Volume: 10 Milliliter
ANTIF 3 V2 F UVHS

  • Multiple-therapy therapeutic drug monitoring IVD, control
ANTIFUNGALS LEVEL 2 V2
UTAK LABORATORIES, INC.
ANTIF 2 V2 F UVHS
In Commercial Distribution

  • B800ANTIF2V2FUVHS5 ()
  • B800ANTIF2V2FUVHS0 ()

  • Total Volume: 10 Milliliter
ANTIF 2 V2 F UVHS

  • Multiple-therapy therapeutic drug monitoring IVD, control
ANTIFUNGALS LEVEL 1 V2
UTAK LABORATORIES, INC.
ANTIF 1 V2 F UVHS
In Commercial Distribution

  • B800ANTIF1V2FUVHS5 ()
  • B800ANTIF1V2FUVHS0 ()

  • Total Volume: 10 Milliliter
ANTIF 1 V2 F UVHS

  • Multiple-therapy therapeutic drug monitoring IVD, control
ANTID LEVEL 3
UTAK LABORATORIES, INC.
ANTID 3 MAYO
In Commercial Distribution

  • B800ANTID3MAYO5 ()
  • B800ANTID3MAYO0 ()

  • Total Volume: 0.75 Milliliter
ANTID 3 MAYO

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

  • B800ANTID2MAYO5 ()
  • B800ANTID2MAYO0 ()

  • Total Volume: 0.75 Milliliter
ANTID 2 MAYO

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

  • B800ANTID1MAYO5 ()
  • B800ANTID1MAYO0 ()

  • Total Volume: 0.75 Milliliter
ANTID 1 MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTIBLKSFUNC
UTAK LABORATORIES, INC.
ANTI BLK S F UNC
In Commercial Distribution

  • B800ANTIBLKSFUNC5 ()
  • B800ANTIBLKSFUNC0 ()

  • Total Volume: 2 Milliliter
ANTI BLK S F UNC

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTI6V2SFUNC
UTAK LABORATORIES, INC.
ANTI 6 V2 S F UNC
In Commercial Distribution

  • B800ANTI6V2SFUNC5 ()
  • B800ANTI6V2SFUNC0 ()

  • Total Volume: 2 Milliliter
ANTI 6 V2 S F UNC

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTIFUNGALS CALIBRATOR 6
UTAK LABORATORIES, INC.
ANTI 6 S F UNC
In Commercial Distribution

  • B800ANTI6SFUNC5 ()
  • B800ANTI6SFUNC0 ()

  • Total Volume: 2 Milliliter
ANTI 6 S F UNC

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTI5V2SFUNC
UTAK LABORATORIES, INC.
ANTI 5 V2 S F UNC
In Commercial Distribution

  • B800ANTI5V2SFUNC5 ()
  • B800ANTI5V2SFUNC0 ()

  • Total Volume: 2 Milliliter
ANTI 5 V2 S F UNC

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTIFUNGALS CALIBRATOR 5
UTAK LABORATORIES, INC.
ANTI 5 S F UNC
In Commercial Distribution

  • B800ANTI5SFUNC5 ()
  • B800ANTI5SFUNC0 ()

  • Total Volume: 2 Milliliter
ANTI 5 S F UNC

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTI4V2SFUNC
UTAK LABORATORIES, INC.
ANTI 4 V2 S F UNC
In Commercial Distribution

  • B800ANTI4V2SFUNC5 ()
  • B800ANTI4V2SFUNC0 ()

  • Total Volume: 2 Milliliter
ANTI 4 V2 S F UNC

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTIFUNGALS CALIBRATOR 4
UTAK LABORATORIES, INC.
ANTI 4 S F UNC
In Commercial Distribution

  • B800ANTI4SFUNC5 ()
  • B800ANTI4SFUNC0 ()

  • Total Volume: 2 Milliliter
ANTI 4 S F UNC

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTI3V2SFUNC
UTAK LABORATORIES, INC.
ANTI 3 V2 S F UNC
In Commercial Distribution

  • B800ANTI3V2SFUNC5 ()
  • B800ANTI3V2SFUNC0 ()

  • Total Volume: 2 Milliliter
ANTI 3 V2 S F UNC

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTIFUNGALS CALIBRATOR 3
UTAK LABORATORIES, INC.
ANTI 3 S F UNC
In Commercial Distribution

  • B800ANTI3SFUNC5 ()
  • B800ANTI3SFUNC0 ()

  • Total Volume: 2 Milliliter
ANTI 3 S F UNC

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTI1V2SFUNC
UTAK LABORATORIES, INC.
ANTI 1 V2 S F UNC
In Commercial Distribution

  • B800ANTI1V2SFUNC5 ()
  • B800ANTI1V2SFUNC0 ()

  • Total Volume: 2 Milliliter
ANTI 1 V2 S F UNC

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

  • B800ANAB2V2ULC5 ()
  • B800ANAB2V2ULC0 ()

  • Total Volume: 5 Milliliter
ANAB+ 2 V2 U LC

  • Multiple-type clinical chemistry analyte profile IVD, control
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
AMYLASE PLUS
UTAK LABORATORIES, INC.
AMYL+ S F DB
In Commercial Distribution

  • B800AMYLSFDB5 ()
  • B800AMYLSFDB0 ()

  • Total Volume: 5 Milliliter
AMYL+ S F DB

  • Multiple drugs of abuse IVD, control
AMPHETAMINE POSITIVE
UTAK LABORATORIES, INC.
AMPH POS WB NC
In Commercial Distribution

  • B800AMPHPOSWBNC5 ()
  • B800AMPHPOSWBNC0 ()

  • Total Volume: 2 Milliliter
AMPH POS WB NC

  • Multiple drugs of abuse IVD, control
AMPHETAMINE PLUS MID
UTAK LABORATORIES, INC.
AMPH+ M U F MAYO
In Commercial Distribution

  • B800AMPHMUFMAYO5 ()
  • B800AMPHMUFMAYO0 ()

  • Total Volume: 1 Milliliter
AMPH+ M U F MAYO

  • Multiple therapeutic drugs/drugs of abuse IVD, control
AMPHETAMINES HIGH
UTAK LABORATORIES, INC.
AMPH H WB F TDPS
In Commercial Distribution

  • B800AMPHHWBFTDPS5 ()
  • B800AMPHHWBFTDPS0 ()

  • Total Volume: 1.5 Milliliter
AMPH H WB F TDPS

  • Multiple drugs of abuse IVD, control
AMPHETAMINE CUTOFF
UTAK LABORATORIES, INC.
AMPH CUT WB NC
In Commercial Distribution

  • B800AMPHCUTWBNC5 ()
  • B800AMPHCUTWBNC0 ()

  • Total Volume: 2 Milliliter
AMPH CUT WB NC

  • Multiple drugs of abuse IVD, control
AMPHETAMINES PLUS BE
UTAK LABORATORIES, INC.
AMPH+ BE U KPRICH
In Commercial Distribution

  • B800AMPHBEUKPRICH5 ()
  • B800AMPHBEUKPRICH0 ()

  • Total Volume: 15 Milliliter
AMPH+ BE U KPRICH

  • Multiple drugs of abuse IVD, control
ALPT23 07
UTAK LABORATORIES, INC.
ALPT23_07
In Commercial Distribution

  • B800ALPT23075 ()
  • B800ALPT23070 ()

  • Total Volume: 1 Milliliter
ALPT23_07

  • Multiple-type clinical chemistry analyte profile IVD, control
ALPT23 06
UTAK LABORATORIES, INC.
ALPT23_06
In Commercial Distribution

  • B800ALPT23065 ()
  • B800ALPT23060 ()

  • Total Volume: 1 Milliliter
ALPT23_06

  • Multiple-type clinical chemistry analyte profile IVD, control
ALPRAZOLAM PLUS
UTAK LABORATORIES, INC.
ALPR+ U F BRL
In Commercial Distribution

  • B800ALPRUFBRL5 ()
  • B800ALPRUFBRL0 ()

  • Total Volume: 2 Milliliter
ALPR+ U F BRL

  • Multiple therapeutic drugs/drugs of abuse 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
ALDOSTERONE LEVEL 3
UTAK LABORATORIES, INC.
ALDO 3 F UVHS
In Commercial Distribution

  • B800ALDO3FUVHS0 ()

  • Total Volume: 10 Milliliter
ALDO 3 F UVHS

  • Multiple-type clinical chemistry analyte profile IVD, control
ALDOSTERONE LEVEL 2
UTAK LABORATORIES, INC.
ALDO 2 F UVHS
In Commercial Distribution

  • B800ALDO2FUVHS0 ()

  • Total Volume: 10 Milliliter
ALDO 2 F UVHS

  • Multiple-type clinical chemistry analyte profile IVD, control
ALDOSTERONE LEVEL 1
UTAK LABORATORIES, INC.
ALDO 1 F UVHS
In Commercial Distribution

  • B800ALDO1FUVHS5 ()
  • B800ALDO1FUVHS0 ()

  • Total Volume: 10 Milliliter
ALDO 1 F UVHS

  • Multiple-type clinical chemistry analyte profile IVD, control
ALDOSTERONE LEVEL 3
UTAK LABORATORIES, INC.
ALD 3 U F LC
In Commercial Distribution

  • B800ALD3UFLC5 ()
  • B800ALD3UFLC0 ()

  • Total Volume: 5 Milliliter
ALD 3 U F LC

  • Multiple-type clinical chemistry analyte profile IVD, control
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