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

  • B800AMINESHV2CONT5 ()
  • B800AMINESHV2CONT0 ()

  • Total Volume: 10 Milliliter
AMINES H V2 CONT

  • Multiple drugs of abuse IVD, control
ALUMINUM LEVEL 3
UTAK LABORATORIES, INC.
ALUM 3 S BP
In Commercial Distribution

  • B800ALUM3SBP5 ()
  • B800ALUM3SBP0 ()

  • Total Volume: 3 Milliliter
ALUM 3 S BP

  • Multiple-type clinical chemistry analyte profile IVD, control
ALUMINUM LEVEL 2
UTAK LABORATORIES, INC.
ALUM 2 S BP
In Commercial Distribution

  • B800ALUM2SBP5 ()
  • B800ALUM2SBP0 ()

  • Total Volume: 3 Milliliter
ALUM 2 S BP

  • 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
ALPT23 ETOH 08
UTAK LABORATORIES, INC.
ALPT23_ETOH 08
In Commercial Distribution

  • B800ALPT23ETOH085 ()
  • B800ALPT23ETOH080 ()

  • Total Volume: 1.25 Milliliter
ALPT23_ETOH 08

  • Multiple-type clinical chemistry analyte profile IVD, control
ALPT23 ETOH 07
UTAK LABORATORIES, INC.
ALPT23_ETOH 07
In Commercial Distribution

  • B800ALPT23ETOH075 ()
  • B800ALPT23ETOH070 ()

  • Total Volume: 1.25 Milliliter
ALPT23_ETOH 07

  • Multiple-type clinical chemistry analyte profile IVD, control
ALPT23 ETOH 06
UTAK LABORATORIES, INC.
ALPT23_ETOH 06
In Commercial Distribution

  • B800ALPT23ETOH065 ()
  • B800ALPT23ETOH060 ()

  • Total Volume: 1.25 Milliliter
ALPT23_ETOH 06

  • Multiple-type clinical chemistry analyte profile IVD, control
ALPT23 09
UTAK LABORATORIES, INC.
ALPT23_09
In Commercial Distribution

  • B800ALPT23095 ()
  • B800ALPT23090 ()

  • Total Volume: 1 Milliliter
ALPT23_09

  • Multiple-type clinical chemistry analyte profile IVD, control
ALPT23 08
UTAK LABORATORIES, INC.
ALPT23_08
In Commercial Distribution

  • B800ALPT23085 ()
  • B800ALPT23080 ()

  • Total Volume: 1 Milliliter
ALPT23_08

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTIFUNGALS LEVEL 1
UTAK LABORATORIES, INC.
A-FUNG L1 S F UW
In Commercial Distribution

  • B800AFUNGL1SFUW6 ()
  • B800AFUNGL1SFUW0 ()

  • Total Volume: 2 Milliliter
A-FUNG L1 S F UW

  • Multiple drugs of abuse IVD, control
ANTIFUNGALS LEVEL 1
UTAK LABORATORIES, INC.
A-FUNG L1 S F MAYO
In Commercial Distribution

  • B800AFUNGL1SFMAYO5 ()
  • B800AFUNGL1SFMAYO0 ()

  • Total Volume: 0.5 Milliliter
A-FUNG L1 S F MAYO

  • Multiple-therapy therapeutic drug monitoring IVD, control
ADS/APS CONTROL SOLUTION V3
UTAK LABORATORIES, INC.
ADS/APSV3CONTFCCO
In Commercial Distribution

  • B800ADSAPSV3CONTFCCO5 ()
  • B800ADSAPSV3CONTFCCO0 ()

  • Total Volume: 25 Milliliter
ADS/APSV3CONTFCCO

  • Multiple-therapy therapeutic drug monitoring IVD, control
ACID-NEUT QC
UTAK LABORATORIES, INC.
ACID-NEUT QC
In Commercial Distribution

  • B800ACIDNEUTQC5 ()
  • B800ACIDNEUTQC0 ()

  • Total Volume: 25 Milliliter
ACID-NEUT QC

  • Multiple-type clinical chemistry analyte profile IVD, control
ACID PLUS
UTAK LABORATORIES, INC.
ACID+ M TCME
In Commercial Distribution

  • B800ACIDMTCME0 ()
  • B800ACIDMTCME5 ()

  • Total Volume: 50 Milliliter
ACID+ M TCME

  • Multiple-type clinical chemistry analyte profile IVD, control
ACETAMINOPHEN PLUS 3
UTAK LABORATORIES, INC.
ACETA+ V3 3 S F BD
In Commercial Distribution

  • B800ACETAV33SFBD5 ()
  • B800ACETAV33SFBD0 ()

  • Total Volume: 4 Milliliter
ACETA+ V3 3 S F BD

  • Multiple drugs of abuse IVD, control
ACETAMINOPHEN PLUS 2
UTAK LABORATORIES, INC.
ACETA+ V3 2 S F BD
In Commercial Distribution

  • B800ACETAV32SFBD5 ()
  • B800ACETAV32SFBD0 ()

  • Total Volume: 4 Milliliter
ACETA+ V3 2 S F BD

  • Multiple drugs of abuse IVD, control
ACETAMINOPHEN PLUS 1
UTAK LABORATORIES, INC.
ACETA+ V3 1 S F BD
In Commercial Distribution

  • B800ACETAV31SFBD5 ()
  • B800ACETAV31SFBD0 ()

  • Total Volume: 4 Milliliter
ACETA+ V3 1 S F BD

  • Multiple drugs of abuse IVD, control
ACETAMINOPHEN PLUS HIGH
UTAK LABORATORIES, INC.
ACETA+ HIGH WB F LC
In Commercial Distribution

  • B800ACETAMINOPHENPLUSH5 ()
  • B800ACETAMINOPHENPLUSH0 ()

  • Total Volume: 5 Milliliter
ACETA+ HIGH WB F LC

  • Multiple-type clinical chemistry analyte profile IVD, control
ACETAMINOPHEN PLUS LOW
UTAK LABORATORIES, INC.
ACETA+ LOW WB F LC
In Commercial Distribution

  • B800ACETALOWWBFLC5 ()
  • B800ACETALOWWBFLC0 ()

  • Total Volume: 5 Milliliter
ACETA+ LOW WB F LC

  • Multiple-therapy therapeutic drug monitoring IVD, control
ACETONE BLANK
UTAK LABORATORIES, INC.
ACE BLK S F BSRHS
In Commercial Distribution

  • B800ACEBLKSFBSRHS5 ()
  • B800ACEBLKSFBSRHS0 ()
  • B800ACEBLKSFBSRHS55 ()

  • Total Volume: 1 Milliliter
ACE BLK S F BSRHS

  • Multiple-type clinical chemistry analyte profile IVD, control
ACETONE 250 MG/DL
UTAK LABORATORIES, INC.
ACE 250 S F BSRHS
In Commercial Distribution

  • B800ACE250SFBSRHS5 ()
  • B800ACE250SFBSRHS0 ()

  • Total Volume: 1 Milliliter
ACE 250 S F BSRHS

  • Multiple-type clinical chemistry analyte profile IVD, control
NICOTINE PLUS LEVEL 2
UTAK LABORATORIES, INC.
90001 U F LTI
In Commercial Distribution

  • B80090001UFLTI5 ()
  • B80090001UFLTI0 ()

  • Total Volume: 3 Milliliter
90001 U F LTI

  • Multiple-type clinical chemistry analyte profile IVD, control
NICOTINE PLUS LEVEL 1
UTAK LABORATORIES, INC.
90000 U F LTI
In Commercial Distribution

  • B80090000UFLTI5 ()
  • B80090000UFLTI0 ()

  • Total Volume: 3 Milliliter
90000 U F LTI

  • Multiple-type clinical chemistry analyte profile IVD, control
B80088121SFA100MLF0
UTAK LABORATORIES, INC.
88121-SFA(100ML-F)
In Commercial Distribution

  • B80088121SFA100MLF5 ()
  • B80088121SFA100MLF0 ()

  • Total Volume: 100 Milliliter
88121-SFA(100ML-F)

  • Multiple-type clinical chemistry analyte profile IVD, control
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