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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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Human Touch - 00045915829698

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

Human Touch - 00045915829681

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

Human Touch - 00045915829629

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

Human Touch - 00045915829605

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

DRUGS OF ABUSE POSITIVE - B800DAPOSV2WBFKBI0

DRUGS OF ABUSE POSITIVE
UTAK LABORATORIES, INC.
DA POS V2 WB F KBI
In Commercial Distribution

  • B800DAPOSV2WBFKBI5 ()
  • B800DAPOSV2WBFKBI0 ()

  • Total Volume: 3 Milliliter
DA POS V2 WB F KBI

  • Multiple drugs of abuse IVD, control

ANTI6V2SFUNC - B800ANTI6V2SFUNC0

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

ANTI5V2SFUNC - B800ANTI5V2SFUNC0

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

ANTI4V2SFUNC - B800ANTI4V2SFUNC0

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

ANTI3V2SFUNC - B800ANTI3V2SFUNC0

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

ANTI2V2SFUNC - B800ANTI2V2SFUNC0

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

ANTI1V2SFUNC - B800ANTI1V2SFUNC0

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

AMITRIPTYLINE PLUS LEVEL 1 - B800AMIT1UFV2TRL0

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

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

STOCK 1 - B80010095200020

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

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

AMPHETAMINE PLUS LEVEL 2 - B80006285000020

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

AMPHETAMINE PLUS LEVEL 1 - B80006285000010

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

NICOTINE PLUS LEVEL 1 - B800NICO1V2FQCLC0

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

IMMUNOSUPPRESSANTS LEVEL 3 - B800IMMU3V2WBFPH0

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 - B800IMMU2V2WBFPH0

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

IMMUNOSUPPRESSANTS LEVEL 1 - B800IMMU1V2WBFPH0

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 - B800GABAVV2WBFMSP0

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 - B800GABA2V2SMXUFPG0

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

ETG PLUS LEVEL 3 - B800ETG3V2UFCCL0

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 - B800ETG2V2UFCCL0

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 - B800ETG1V2UFCCL0

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

DRUGS OF ABUSE CAL LEVEL 2 - B800DAULLEVEL2V2URMC0

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 - B800DAULLEVEL1V2URMC0

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
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