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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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
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
DRUGS OF ABUSE QC 3
UTAK LABORATORIES, INC.
DAU QC 3 V2 F BILH
In Commercial Distribution

  • B800DAUQC3V2FBILH5 ()
  • B800DAUQC3V2FBILH0 ()

  • Total Volume: 2 Milliliter
DAU QC 3 V2 F BILH

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE QC 1
UTAK LABORATORIES, INC.
DAU QC 1 V2 F BILH
In Commercial Distribution

  • B800DAUQC1V2FBILH5 ()
  • B800DAUQC1V2FBILH0 ()

  • Total Volume: 2 Milliliter
DAU QC 1 V2 F BILH

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE POSITIVE
UTAK LABORATORIES, INC.
DAU POS V2 U F PHHC
In Commercial Distribution

  • B800DAUPOSV2UFPHHC5 ()
  • B800DAUPOSV2UFPHHC0 ()

  • Total Volume: 3 Milliliter
DAU POS V2 U F PHHC

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE CAL LEVEL 2
UTAK LABORATORIES, INC.
DAU+ L LEVEL 2 V2 URMC
In Commercial Distribution

  • B800DAULLEVEL2V2URMC5 ()
  • B800DAULLEVEL2V2URMC0 ()

  • Total Volume: 5 Milliliter
DAU+ L LEVEL 2 V2 URMC

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE CAL LEVEL 1
UTAK LABORATORIES, INC.
DAU+ L LEVEL 1 V2 URMC
In Commercial Distribution

  • B800DAULLEVEL1V2URMC5 ()
  • B800DAULLEVEL1V2URMC0 ()

  • Total Volume: 5 Milliliter
DAU+ L LEVEL 1 V2 URMC

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE LEVEL 3
UTAK LABORATORIES, INC.
DAU 3 V2 F U VMG
In Commercial Distribution

  • B800DAU3V2FUVMG0 ()
  • B800DAU3V2FUVMG05 ()
  • B800DAU3V2FUVMG5 ()

  • Total Volume: 10 Milliliter
DAU 3 V2 F U VMG

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE LEVEL 2
UTAK LABORATORIES, INC.
DAU 2 V2 F U VMG
In Commercial Distribution

  • B800DAU2V2FUVMG5 ()
  • B800DAU2V2FUVMG0 ()

  • Total Volume: 10 Milliliter
DAU 2 V2 F U VMG

  • Multiple therapeutic drugs/drugs of abuse IVD, control
DRUGS OF ABUSE LEVEL 1
UTAK LABORATORIES, INC.
DAU 1 V2 F U VMG
In Commercial Distribution

  • B800DAU1V2FUVMG5 ()
  • B800DAU1V2FUVMG0 ()

  • Total Volume: 10 Milliliter
DAU 1 V2 F U VMG

  • Multiple drugs of abuse IVD, control
VORICONAZOLE PLUS 3
UTAK LABORATORIES, INC.
VOR+ 3 V2 S F UNC
In Commercial Distribution

  • B800VOR3V2SFUNC5 ()
  • B800VOR3V2SFUNC0 ()

  • Total Volume: 2 Milliliter
VOR+ 3 V2 S F UNC

  • Multiple-therapy therapeutic drug monitoring IVD, control
VORICONAZOLE PLUS 2
UTAK LABORATORIES, INC.
VOR+ 2 V2 S F UNC
In Commercial Distribution

  • B800VOR2V2SFUNC5 ()
  • B800VOR2V2SFUNC0 ()

  • Total Volume: 2 Milliliter
VOR+ 2 V2 S F UNC

  • Multiple-therapy therapeutic drug monitoring IVD, control
VORICONAZOLE PLUS 1
UTAK LABORATORIES, INC.
VOR+ 1 V2 S F UNC
In Commercial Distribution

  • B800VOR1V2SFUNC5 ()
  • B800VOR1V2SFUNC0 ()

  • Total Volume: 2 Milliliter
VOR+ 1 V2 S F UNC

  • Multiple-therapy therapeutic drug monitoring IVD, control
VOLATILES LEVEL 2
UTAK LABORATORIES, INC.
VOL 2 V2 S F RIH
In Commercial Distribution

  • B800VOL2V2SFRIH5 ()
  • B800VOL2V2SFRIH0 ()

  • Total Volume: 5 Milliliter
VOL 2 V2 S F RIH

  • Multiple drugs of abuse IVD, control
VOLATILES LEVEL 1
UTAK LABORATORIES, INC.
VOL 1 V2 S F RIH
In Commercial Distribution

  • B800VOL1V2SFRIH5 ()
  • B800VOL1V2SFRIH0 ()

  • Total Volume: 5 Milliliter
VOL 1 V2 S F RIH

  • Multiple drugs of abuse IVD, control
TESTOSTERONE 7.5 NG/DL
UTAK LABORATORIES, INC.
TESTO 7.5 V2 S F LCMS
In Commercial Distribution

  • B800TESTO75V2SFLCMS5 ()
  • B800TESTO75V2SFLCMS0 ()

  • Total Volume: 1.1 Milliliter
TESTO 7.5 V2 S F LCMS

  • Multiple-type clinical chemistry analyte profile IVD, control
PETH LEVEL 3
UTAK LABORATORIES, INC.
PETH 3 V2 WB F MAYO
In Commercial Distribution

  • B800PETH3V2WBFMAYO5 ()
  • B800PETH3V2WBFMAYO0 ()

  • Total Volume: 1 Milliliter
PETH 3 V2 WB F MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
OXAZEPAM GLUCURONIDE
UTAK LABORATORIES, INC.
OXA GLUC V2 U F HCMC
In Commercial Distribution

  • B800OXAGLUCV2UFHCMC5 ()
  • B800OXAGLUCV2UFHCMC0 ()

  • Total Volume: 2 Milliliter
OXA GLUC V2 U F HCMC

  • Multiple drugs of abuse IVD, control
NICOTINE PLUS LEVEL 1
UTAK LABORATORIES, INC.
NICO+ 1 V2 F QC LC
In Commercial Distribution

  • B800NICO1V2FQCLC5 ()
  • B800NICO1V2FQCLC0 ()

  • Total Volume: 5 Milliliter
NICO+ 1 V2 F QC LC

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 1
UTAK LABORATORIES, INC.
LEAD 1 V2 WB V WDL
In Commercial Distribution

  • B800LEAD1V2WBVWDL5 ()
  • B800LEAD1V2WBVWDL0 ()

  • Total Volume: 15 Milliliter
LEAD 1 V2 WB V WDL

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 1
UTAK LABORATORIES, INC.
LEAD 1 V2 WB F CH
In Commercial Distribution

  • B800LEAD1V2WBFCH5 ()
  • B800LEAD1V2WBFCH0 ()

  • Total Volume: 0.5 Milliliter
LEAD 1 V2 WB F CH

  • Multiple-type clinical chemistry analyte profile IVD, control
IMMUNOSUPPRESSANTS LEVEL 3
UTAK LABORATORIES, INC.
IMMU 3 V2 WB F PH
In Commercial Distribution

  • B800IMMU3V2WBFPH5 ()
  • B800IMMU3V2WBFPH0 ()

  • Total Volume: 2 Milliliter
IMMU 3 V2 WB F PH

  • Multiple-type clinical chemistry analyte profile IVD, control
IMMUNOSUPPRESSANTS LEVEL 2
UTAK LABORATORIES, INC.
IMMU 2 V2 WB F PH
In Commercial Distribution

  • B800IMMU2V2WBFPH5 ()
  • B800IMMU2V2WBFPH0 ()
IMMU 2 V2 WB F PH

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
UTAK LABORATORIES, INC.
IMMU 1 V2 WB F PH
In Commercial Distribution

  • B800IMMU1V2WBFPH5 ()
  • B800IMMU1V2WBFPH0 ()

  • Total Volume: 2 Milliliter
IMMU 1 V2 WB F PH

  • Multiple-type clinical chemistry analyte profile IVD, control
GABAPENTIN PLUS
UTAK LABORATORIES, INC.
GABA+ V V2 WB F MSP
In Commercial Distribution

  • B800GABAVV2WBFMSP5 ()
  • B800GABAVV2WBFMSP0 ()

  • Total Volume: 50 Milliliter
GABA+ V V2 WB F MSP

  • Multiple drugs of abuse IVD, control
GABAPENTIN LEVEL 2
UTAK LABORATORIES, INC.
GABA 2 V2 SMXU F PG
In Commercial Distribution

  • B800GABA2V2SMXUFPG5 ()
  • B800GABA2V2SMXUFPG0 ()

  • Total Volume: 2.5 Milliliter
GABA 2 V2 SMXU F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
ETHYLENE GLYCOL LEVEL 2
UTAK LABORATORIES, INC.
ETHGLY 2 V2 S F RIH
In Commercial Distribution

  • B800ETHGLY2V2SFRIH0 ()
  • B800ETHGLY2V2SFRIH5 ()

  • Total Volume: 5 Milliliter
ETHGLY 2 V2 S F RIH

  • Ethylene glycol IVD, control
ETG PLUS LEVEL 3
UTAK LABORATORIES, INC.
ETG+ 3 V2 U F CCL
In Commercial Distribution

  • B800ETG3V2UFCCL5 ()
  • B800ETG3V2UFCCL0 ()

  • Total Volume: 2 Milliliter
ETG+ 3 V2 U F CCL

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

  • B800ETG2V2UFCCL5 ()
  • B800ETG2V2UFCCL0 ()

  • Total Volume: 2 Milliliter
ETG+ 2 V2 U F CCL

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

  • B800ETG1V2UFCCL5 ()
  • B800ETG1V2UFCCL0 ()

  • Total Volume: 2 Milliliter
ETG+ 1 V2 U F CCL

  • Multiple-type clinical chemistry analyte profile IVD, control
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
No Description
UTAK LABORATORIES, INC.
STK 1 WB V2 BD 22
In Commercial Distribution

  • B80010095200020 ()
  • B80010095200021 ()
  • B80010095200022 ()
  • B80010095200023 ()
  • B80010095200026 ()
  • B80010095200027 ()
  • B80010095200028 ()


  • Multiple heavy metal IVD, control
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
No Description
UTAK LABORATORIES, INC.
AMPH+ 2 U V2 F WBH
In Commercial Distribution

  • B80006285000021 ()
  • B80006285000020 ()
  • B80006285000022 ()
  • B80006285000023 ()
  • B80006285000026 ()
  • B80006285000027 ()
  • B80006285000028 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
AMPH+ 1 U V2 F WBH
In Commercial Distribution

  • B80006285000010 ()
  • B80006285000011 ()
  • B80006285000012 ()
  • B80006285000013 ()
  • B80006285000016 ()
  • B80006285000017 ()
  • B80006285000018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.
Human Touch, LLC
HT GRAVIS PAD SET SAND V2
In Commercial Distribution

  • 00045915829698 ()
100-GRAVIS-019

  • Bed/chair electric massager
A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.
Human Touch, LLC
HT GRAVIS PAD SET SADDLE V2
In Commercial Distribution

  • 00045915829681 ()
100-GRAVIS-018

  • Bed/chair electric massager
A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.
Human Touch, LLC
HT GRAVIS PAD SET GRAY V2
In Commercial Distribution

  • 00045915829629 ()
100-GRAVIS-017

  • Bed/chair electric massager
A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.
Human Touch, LLC
HT GRAVIS PAD SET BLACK V2
In Commercial Distribution

  • 00045915829612 ()
100-GRAVIS-016

  • Bed/chair electric massager
A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.
Human Touch, LLC
HT GRAVIS PAD SET BONE V2
In Commercial Distribution

  • 00045915829605 ()
100-GRAVIS-020

  • Bed/chair electric massager
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