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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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
ANTI2V2SFUNC
UTAK LABORATORIES, INC.
ANTI 2 V2 S F UNC
In Commercial Distribution

  • B800ANTI2V2SFUNC5 ()
  • B800ANTI2V2SFUNC0 ()

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

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTIFUNGALS CALIBRATOR 2
UTAK LABORATORIES, INC.
ANTI 2 S F UNC
In Commercial Distribution

  • B800ANTI2SFUNC2 ()
  • B800ANTI2SFUNC0 ()

  • Total Volume: 2 Milliliter
ANTI 2 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
ANTIFUNGALS CALIBRATOR 1
UTAK LABORATORIES, INC.
ANTI 1 S F UNC
In Commercial Distribution

  • B800ANTI1SFUNC5 ()
  • B800ANTI1SFUNC0 ()

  • Total Volume: 2 Milliliter
ANTI 1 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 2
UTAK LABORATORIES, INC.
ANAB+ 2 U LC
In Commercial Distribution

  • B800ANAB2ULC5 ()
  • B800ANAB2ULC0 ()

  • Total Volume: 5 Milliliter
ANAB+ 2 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
ANABASINE PLUS LEVEL 1
UTAK LABORATORIES, INC.
ANAB+ 1 U LC
In Commercial Distribution

  • B800ANAB1ULC5 ()
  • B800ANAB1ULC0 ()

  • Total Volume: 5 Milliliter
ANAB+ 1 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 POSITIVE
UTAK LABORATORIES, INC.
AMPH POS S NC
In Commercial Distribution

  • B800AMPHPOSSNC5 ()
  • B800AMPHPOSSNC0 ()

  • Total Volume: 2 Milliliter
AMPH POS S 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 LOW
UTAK LABORATORIES, INC.
AMPH L WB F TDPS
In Commercial Distribution

  • B800AMPHLWBFTDPS5 ()
  • B800AMPHLWBFTDPS0 ()

  • Total Volume: 1.5 Milliliter
AMPH L WB F TDPS

  • Multiple 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
AMPHETAMINE CUTOFF
UTAK LABORATORIES, INC.
AMPH CUT S NC
In Commercial Distribution

  • B800AMPHCUTSNC5 ()
  • B800AMPHCUTSNC0 ()

  • Total Volume: 2 Milliliter
AMPH CUT S 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
AMPHETAMINE PLUS LEVEL 2
UTAK LABORATORIES, INC.
AMPH+ 2 WB 2PT F V2 SDHL
In Commercial Distribution

  • B800AMPH2WB2PTFV2SDHL5 ()
  • B800AMPH2WB2PTFV2SDHL0 ()

  • Total Volume: 1 Milliliter
AMPH+ 2 WB 2PT F V2 SDHL

  • Multiple-type clinical chemistry analyte profile IVD, control
AMPHETAMINE PLUS LEVEL 2 V4
UTAK LABORATORIES, INC.
AMPH+ 2 U V4 F WBH
In Commercial Distribution

  • B800AMPH2UV4FWBH5 ()
  • B800AMPH2UV4FWBH0 ()

  • Total Volume: 10 Milliliter
AMPH+ 2 U V4 F WBH

  • Multiple-type clinical chemistry analyte profile IVD, control
AMPHETAMINE PLUS LEVEL 2
UTAK LABORATORIES, INC.
AMPH+ 2 U V3 F WBH
In Commercial Distribution

  • B800AMPH2UV3FWBH5 ()
  • B800AMPH2UV3FWBH0 ()

  • Total Volume: -10 Milliliter
  • Total Volume: 10 Milliliter
AMPH+ 2 U V3 F WBH

  • Multiple-type clinical chemistry analyte profile IVD, control
AMPHETAMINES PANEL LEVEL 2
UTAK LABORATORIES, INC.
AMPH 2 U F UW
In Commercial Distribution

  • B800AMPH2UFUW5 ()
  • B800AMPH2UFUW0 ()

  • Total Volume: .32 Milliliter
AMPH 2 U F UW

  • Multiple drugs of abuse IVD, control
AMPHETAMINE PLUS LEVEL 1
UTAK LABORATORIES, INC.
AMPH+ 1 WB 2PT F V2 SDHL
In Commercial Distribution

  • B800AMPH1WB2PTFV2SDHL5 ()
  • B800AMPH1WB2PTFV2SDHL0 ()

  • Total Volume: 1 Milliliter
AMPH+ 1 WB 2PT F V2 SDHL

  • Multiple-type clinical chemistry analyte profile IVD, control
AMPHETAMINE PLUS LEVEL 1
UTAK LABORATORIES, INC.
AMPH+ 1 U V3 F WBH
In Commercial Distribution

  • B800AMPH1UV3FWBH5 ()
  • B800AMPH1UV3FWBH0 ()

  • Total Volume: 10 Milliliter
  • Total Volume: -10 Milliliter
AMPH+ 1 U V3 F WBH

  • Multiple-type clinical chemistry analyte profile IVD, control
AMPHETAMINES PANEL LEVEL 1
UTAK LABORATORIES, INC.
AMPH 1 U F UW
In Commercial Distribution

  • B800AMPH1UFUW5 ()
  • B800AMPH1UFUW0 ()

  • Total Volume: .32 Milliliter
AMPH 1 U F UW

  • Multiple drugs of abuse IVD, control
AMITRIPTYLINE PLUS
UTAK LABORATORIES, INC.
AMIT+ V2 U F BRL
In Commercial Distribution

  • B800AMITV2UFBRL5 ()
  • B800AMITV2UFBRL0 ()

  • Total Volume: 2 Milliliter
AMIT+ V2 U F BRL

  • Multiple therapeutic drugs/drugs of abuse IVD, control
AMITRIPTYLINE PLUS
UTAK LABORATORIES, INC.
AMIT+ S WVHS
In Commercial Distribution

  • B800AMITSWVHS5 ()
  • B800AMITSWVHS0 ()

  • Total Volume: 5 Milliliter
AMIT+ S WVHS

  • 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
AMITRIPTYLINE PLUS LEVEL 2
UTAK LABORATORIES, INC.
AMIT+ 2 F DW ECME
In Commercial Distribution

  • B800AMIT2FDWECME5 ()
  • B800AMIT2FDWECME0 ()

  • Total Volume: 2 Milliliter
AMIT+ 2 F DW ECME

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

  • B800AMIT1UFV2TRL5 ()
  • B800AMIT1UFV2TRL0 ()

  • Total Volume: 1 Milliliter
AMIT+ 1 U F V2 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 2
UTAK LABORATORIES, INC.
AMIO 2 S F QDVA
In Commercial Distribution

  • B800AMIO2SFQDVA5 ()
  • B800AMIO2SFQDVA0 ()

  • Total Volume: 5 Milliliter
AMIO 2 S F QDVA

  • 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
AMINES LOW
UTAK LABORATORIES, INC.
AMINES H V2 CONT
In Commercial Distribution

  • B800AMINESLCONT5 ()
  • B800AMINESLCONT0 ()

  • Total Volume: 10 Milliliter
AMINES H V2 CONT

  • Multiple drugs of abuse 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
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