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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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FENTANYL PLUS LEVEL 2 - B80003716500040

FENTANYL PLUS LEVEL 2
UTAK LABORATORIES, INC.
FENT+ 2 U PM
In Commercial Distribution

  • B80003716500041 ()
  • B80003716500040 ()
  • B80003716500042 ()
  • B80003716500043 ()
  • B80003716500046 ()
  • B80003716500047 ()
  • B80003716500048 ()


  • Opiate/opiate metabolite IVD, control

FENTANYL PLUS LEVEL 1 - B80003716500030

FENTANYL PLUS LEVEL 1
UTAK LABORATORIES, INC.
FENT+ 1 U PM
In Commercial Distribution

  • B80003716500031 ()
  • B80003716500030 ()
  • B80003716500032 ()
  • B80003716500033 ()
  • B80003716500036 ()
  • B80003716500037 ()
  • B80003716500038 ()


  • Opiate/opiate metabolite IVD, control

4308 LEVEL 2 - B80003716500020

No Description
UTAK LABORATORIES, INC.
430805C08
In Commercial Distribution

  • B80003716500020 ()
  • B80003716500021 ()
  • B80003716500022 ()
  • B80003716500023 ()
  • B80003716500026 ()
  • B80003716500027 ()
  • B80003716500028 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

4308 LEVEL 1 - B80003716500010

No Description
UTAK LABORATORIES, INC.
430806C08
In Commercial Distribution

  • B80003716500010 ()
  • B80003716500011 ()
  • B80003716500012 ()
  • B80003716500013 ()
  • B80003716500016 ()
  • B80003716500017 ()
  • B80003716500018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

P/Z QC V2 LOW - B80002942500100

No Description
UTAK LABORATORIES, INC.
P/Z QC V2 L U F ML
In Commercial Distribution

  • B80002942500101 ()
  • B80002942500100 ()
  • B80002942500102 ()
  • B80002942500103 ()
  • B80002942500106 ()
  • B80002942500107 ()
  • B80002942500108 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

OF QC 3 - B80002942500090

No Description
UTAK LABORATORIES, INC.
QC 3 SMX-OF
In Commercial Distribution

  • B80002942500091 ()
  • B80002942500090 ()
  • B80002942500092 ()
  • B80002942500093 ()
  • B80002942500096 ()
  • B80002942500097 ()
  • B80002942500098 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

OF QC 4 - B80002942500080

No Description
UTAK LABORATORIES, INC.
QC 4 SMX-OF
In Commercial Distribution

  • B80002942500080 ()
  • B80002942500081 ()
  • B80002942500082 ()
  • B80002942500083 ()
  • B80002942500086 ()
  • B80002942500087 ()
  • B80002942500088 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

DRUGS OF ABUSE CALIBRATOR V6 - B80002942500070

No Description
UTAK LABORATORIES, INC.
DOA CAL P OF V6
In Commercial Distribution

  • B80002942500071 ()
  • B80002942500070 ()
  • B80002942500072 ()
  • B80002942500073 ()
  • B80002942500076 ()
  • B80002942500077 ()
  • B80002942500078 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

P/Z QC HIGH - B80002942500060

No Description
UTAK LABORATORIES, INC.
P/Z QC H U F ML
In Commercial Distribution

  • B80002942500060 ()
  • B80002942500061 ()
  • B80002942500062 ()
  • B80002942500063 ()
  • B80002942500066 ()
  • B80002942500067 ()
  • B80002942500068 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

P/Z QC LOW - B80002942500050

No Description
UTAK LABORATORIES, INC.
P/Z QC LOW
In Commercial Distribution

  • B80002942500051 ()
  • B80002942500050 ()
  • B80002942500052 ()
  • B80002942500053 ()
  • B80002942500056 ()
  • B80002942500057 ()
  • B80002942500058 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

P/Z CALIBRATOR V2 - B80002942500040

No Description
UTAK LABORATORIES, INC.
P/Z CAL V2 U F ML
In Commercial Distribution

  • B80002942500041 ()
  • B80002942500040 ()
  • B80002942500042 ()
  • B80002942500043 ()
  • B80002942500046 ()
  • B80002942500047 ()
  • B80002942500048 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

PSYCH URINE V3 CALIBRATOR - B80002942500030

No Description
UTAK LABORATORIES, INC.
PSY UR V3 CAL
In Commercial Distribution

  • B80002942500030 ()
  • B80002942500031 ()
  • B80002942500032 ()
  • B80002942500033 ()
  • B80002942500036 ()
  • B80002942500037 ()
  • B80002942500038 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

P/Z CALIBRATOR - B80002942500020

No Description
UTAK LABORATORIES, INC.
P/Z CAL U F ML
In Commercial Distribution

  • B80002942500020 ()
  • B80002942500021 ()
  • B80002942500022 ()
  • B80002942500023 ()
  • B80002942500026 ()
  • B80002942500027 ()
  • B80002942500028 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

PM PANEL COMBO V9 - B80002942500010

No Description
UTAK LABORATORIES, INC.
PM PAN COM V9
In Commercial Distribution

  • B80002942500010 ()
  • B80002942500011 ()
  • B80002942500012 ()
  • B80002942500013 ()
  • B80002942500016 ()
  • B80002942500017 ()
  • B80002942500018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

VITAMIN D PLUS LEVEL 2 - B80002141500030

No Description
UTAK LABORATORIES, INC.
VIT D+ 2 S KPRICH
In Commercial Distribution

  • B80002141500030 ()
  • B80002141500031 ()
  • B80002141500032 ()
  • B80002141500033 ()
  • B80002141500036 ()
  • B80002141500037 ()
  • B80002141500038 ()


  • Multiple form 25-hydroxy Vitamin D IVD, control

VITAMIN D PLUS LEVEL 1 - B80002141500020

No Description
UTAK LABORATORIES, INC.
VIT D+ 1 S KPRICH
In Commercial Distribution

  • B80002141500020 ()
  • B80002141500021 ()
  • B80002141500022 ()
  • B80002141500023 ()
  • B80002141500026 ()
  • B80002141500027 ()
  • B80002141500028 ()


  • Multiple form 25-hydroxy Vitamin D IVD, control

VITAMIN D PLUS LOW - B80002141500010

No Description
UTAK LABORATORIES, INC.
VIT D+ L S KPRICH
In Commercial Distribution

  • B80002141500010 ()
  • B80002141500011 ()
  • B80002141500012 ()
  • B80002141500013 ()
  • B80002141500016 ()
  • B80002141500017 ()
  • B80002141500018 ()


  • Multiple form 25-hydroxy Vitamin D IVD, control

DRUGS OF ABUSE LEVEL 3 - B80002041000030

DRUGS OF ABUSE LEVEL 3
UTAK LABORATORIES, INC.
DA 3 S IDC
In Commercial Distribution

  • B80002041000031 ()
  • B80002041000030 ()
  • B80002041000032 ()
  • B80002041000033 ()
  • B80002041000036 ()
  • B80002041000037 ()
  • B80002041000038 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

DRUGS OF ABUSE LEVEL 2 - B80002041000020

DRUGS OF ABUSE LEVEL 2
UTAK LABORATORIES, INC.
DA 2 S IDC
In Commercial Distribution

  • B80002041000021 ()
  • B80002041000020 ()
  • B80002041000022 ()
  • B80002041000023 ()
  • B80002041000026 ()
  • B80002041000027 ()
  • B80002041000028 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

DRUGS OF ABUSE LEVEL 1 - B80002041000010

DRUGS OF ABUSE LEVEL 1
UTAK LABORATORIES, INC.
DA 1 S IDC
In Commercial Distribution

  • B80002041000011 ()
  • B80002041000010 ()
  • B80002041000012 ()
  • B80002041000013 ()
  • B80002041000016 ()
  • B80002041000017 ()
  • B80002041000018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

GHB 20 MG/L - B80001978000020

GHB 20 MG/L
UTAK LABORATORIES, INC.
GHB 20 U IN
In Commercial Distribution

  • B80001978000021 ()
  • B80001978000020 ()
  • B80001978000022 ()
  • B80001978000023 ()
  • B80001978000026 ()
  • B80001978000027 ()
  • B80001978000028 ()


  • Gamma-hydroxybutyrate (GHB) IVD, control

BUSULFAN LEVEL 3 - B80001696000090

BUSULFAN LEVEL 3
UTAK LABORATORIES, INC.
BUS 3 P F UK
In Commercial Distribution

  • B80001696000091 ()
  • B80001696000090 ()
  • B80001696000092 ()
  • B80001696000093 ()
  • B80001696000096 ()
  • B80001696000097 ()
  • B80001696000098 ()


  • Busulfan therapeutic drug monitoring IVD, control

BUSULFAN LEVEL 2 - B80001696000080

BUSULFAN LEVEL 2
UTAK LABORATORIES, INC.
BUS 2 P F UK
In Commercial Distribution

  • B80001696000081 ()
  • B80001696000080 ()
  • B80001696000082 ()
  • B80001696000083 ()
  • B80001696000086 ()
  • B80001696000087 ()
  • B80001696000088 ()


  • Busulfan therapeutic drug monitoring IVD, control

BUSULFAN LEVEL 1 - B80001696000070

BUSULFAN LEVEL 1
UTAK LABORATORIES, INC.
BUS 1 P F UK
In Commercial Distribution

  • B80001696000071 ()
  • B80001696000070 ()
  • B80001696000072 ()
  • B80001696000073 ()
  • B80001696000076 ()
  • B80001696000077 ()
  • B80001696000078 ()


  • Busulfan therapeutic drug monitoring IVD, control

METALS LEVEL 2 - B80001696000040

METALS LEVEL 2
UTAK LABORATORIES, INC.
MET T 2 DP UK
In Commercial Distribution

  • B80001696000041 ()
  • B80001696000040 ()
  • B80001696000042 ()
  • B80001696000043 ()
  • B80001696000046 ()
  • B80001696000047 ()
  • B80001696000048 ()


  • Multiple heavy metal IVD, control

METALS LEVEL 1 - B80001696000030

METALS LEVEL 1
UTAK LABORATORIES, INC.
MET T 1 DP UK
In Commercial Distribution

  • B80001696000031 ()
  • B80001696000030 ()
  • B80001696000032 ()
  • B80001696000033 ()
  • B80001696000036 ()
  • B80001696000037 ()
  • B80001696000038 ()


  • Multiple heavy metal IVD, control

METALS LEVEL 2 - B80001696000020

METALS LEVEL 2
UTAK LABORATORIES, INC.
MET T 2 WB UK
In Commercial Distribution

  • B80001696000021 ()
  • B80001696000020 ()
  • B80001696000022 ()
  • B80001696000023 ()
  • B80001696000026 ()
  • B80001696000027 ()
  • B80001696000028 ()


  • Multiple heavy metal IVD, control

METALS LEVEL 1 - B80001696000010

METALS LEVEL 1
UTAK LABORATORIES, INC.
MET T 1 WB UK
In Commercial Distribution

  • B80001696000011 ()
  • B80001696000010 ()
  • B80001696000012 ()
  • B80001696000013 ()
  • B80001696000016 ()
  • B80001696000017 ()
  • B80001696000018 ()


  • Multiple heavy metal IVD, control

URINE QC HIGH - B80001390500040

No Description
UTAK LABORATORIES, INC.
U QC HIGH V2 EL
In Commercial Distribution

  • B80001390500040 ()
  • B80001390500041 ()
  • B80001390500042 ()
  • B80001390500043 ()
  • B80001390500046 ()
  • B80001390500047 ()
  • B80001390500048 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

URINE QC LOW - B80001390500030

No Description
UTAK LABORATORIES, INC.
U QC LOW V2 EL
In Commercial Distribution

  • B80001390500030 ()
  • B80001390500031 ()
  • B80001390500032 ()
  • B80001390500033 ()
  • B80001390500036 ()
  • B80001390500037 ()
  • B80001390500038 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

URINE QC HIGH - B80001390500020

No Description
UTAK LABORATORIES, INC.
U QC HIGH EL
In Commercial Distribution

  • B80001390500021 ()
  • B80001390500020 ()
  • B80001390500022 ()
  • B80001390500023 ()
  • B80001390500026 ()
  • B80001390500027 ()
  • B80001390500028 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

URINE QC LOW - B80001390500010

No Description
UTAK LABORATORIES, INC.
U QC LOW EL
In Commercial Distribution

  • B80001390500011 ()
  • B80001390500010 ()
  • B80001390500012 ()
  • B80001390500013 ()
  • B80001390500016 ()
  • B80001390500017 ()
  • B80001390500018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

7-AMINO PLUS 100 NG/ML - B80000357500030

7-AMINO PLUS 100 NG/ML
UTAK LABORATORIES, INC.
7-AMINO+ 100 MP
In Commercial Distribution

  • B80000357500031 ()
  • B80000357500030 ()
  • B80000357500032 ()
  • B80000357500033 ()
  • B80000357500036 ()
  • B80000357500037 ()
  • B80000357500038 ()


  • Benzodiazepine group IVD, control

DAU +25% GCMS - B80000357500020

DAU +25% GCMS
UTAK LABORATORIES, INC.
DAU +25 GCMS
In Commercial Distribution

  • B80000357500021 ()
  • B80000357500020 ()
  • B80000357500022 ()
  • B80000357500023 ()
  • B80000357500026 ()
  • B80000357500027 ()
  • B80000357500028 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

DAU -25% GCMS - B80000357500010

DAU -25% GCMS
UTAK LABORATORIES, INC.
DAU -25 GCMS
In Commercial Distribution

  • B80000357500011 ()
  • B80000357500010 ()
  • B80000357500012 ()
  • B80000357500013 ()
  • B80000357500016 ()
  • B80000357500017 ()
  • B80000357500018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

BUSULFAN QC LEVEL 1 - B80010106500010

No Description
UTAK LABORATORIES, INC.
BUS QC 1 F SHP BHM
In Commercial Distribution

  • B80010106500010 ()
  • B80010106500011 ()
  • B80010106500012 ()
  • B80010106500013 ()
  • B80010106500016 ()
  • B80010106500017 ()
  • B80010106500018 ()


  • Busulfan therapeutic drug monitoring IVD, control

STOCK 4 - B80010095200050

No Description
UTAK LABORATORIES, INC.
STK 4 WB V2 BD 22
In Commercial Distribution

  • B80010095200051 ()
  • B80010095200050 ()
  • B80010095200052 ()
  • B80010095200053 ()
  • B80010095200056 ()
  • B80010095200057 ()
  • B80010095200058 ()


  • Multiple heavy metal IVD, control

STOCK 3 - B80010095200040

No Description
UTAK LABORATORIES, INC.
STK 3 WB V2 BD 22
In Commercial Distribution

  • B80010095200041 ()
  • B80010095200040 ()
  • B80010095200042 ()
  • B80010095200043 ()
  • B80010095200046 ()
  • B80010095200047 ()
  • B80010095200048 ()


  • Multiple heavy metal IVD, control

STOCK 2 - B80010095200030

No Description
UTAK LABORATORIES, INC.
STK 2 WB V2 BD 22
In Commercial Distribution

  • B80010095200030 ()
  • B80010095200031 ()
  • B80010095200032 ()
  • B80010095200033 ()
  • B80010095200036 ()
  • B80010095200037 ()
  • B80010095200038 ()


  • Multiple heavy metal IVD, control

ACETAMINOPHEN PLUS HIGH - B80010095200010

No Description
UTAK LABORATORIES, INC.
ACETA+ HIGH V2 S F BD
In Commercial Distribution

  • B80010095200010 ()
  • B80010095200011 ()
  • B80010095200012 ()
  • B80010095200013 ()
  • B80010095200016 ()
  • B80010095200017 ()
  • B80010095200018 ()


  • Multiple-therapy therapeutic drug monitoring IVD, control
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