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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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ETG Plus Level 1 - B800130200

ETG Plus Level 1
UTAK LABORATORIES, INC.
13020
In Commercial Distribution

  • B800130205 ()
  • B800130200 ()

  • Total Volume: 5 Milliliter
13020

  • Ethyl glucuronide (EtG) IVD, control

High Range Urine Metals - B800121100

HR Urine Metals
UTAK LABORATORIES, INC.
12110
In Commercial Distribution

  • B800121105 ()
  • B800121100 ()

  • Total Volume: 5 Milliliter
12110

  • Multiple heavy metal IVD, control

Methotrexate Level 4 - B800121060

Methotrexate Level 4
UTAK LABORATORIES, INC.
12106
In Commercial Distribution

  • B800121065 ()
  • B800121060 ()

  • Total Volume: 5 Milliliter
12106

  • Methotrexate therapeutic drug monitoring IVD, control

Methotrexate Level 3 - B800121050

Methotrexate Level 3
UTAK LABORATORIES, INC.
12105
In Commercial Distribution

  • B800121055 ()
  • B800121050 ()

  • Total Volume: 5 Milliliter
12105

  • Methotrexate therapeutic drug monitoring IVD, control

Methotrexate Level 2 - B800121040

Methotrexate Level 2
UTAK LABORATORIES, INC.
12104
In Commercial Distribution

  • B800121045 ()
  • B800121040 ()

  • Total Volume: 5 Milliliter
12104

  • Methotrexate therapeutic drug monitoring IVD, control

Methotrexate Level 1 - B800121030

Methotrexate Level 1
UTAK LABORATORIES, INC.
12103
In Commercial Distribution

  • B800121035 ()
  • B800121030 ()

  • Total Volume: 5 Milliliter
12103

  • Methotrexate therapeutic drug monitoring IVD, control

Benzodiazepines Plus 100ng - B800121000

Benzodiazepines Plus 100ng
UTAK LABORATORIES, INC.
12100
In Commercial Distribution

  • B800121005 ()
  • B800121000 ()

  • Total Volume: 5 Milliliter
12100

  • Benzodiazepine group IVD, control

Benzodiazepines Plus 400ng/mL - B800120910

Benzodiazepines Plus 400ng/mL
UTAK LABORATORIES, INC.
12091
In Commercial Distribution

  • B800120915 ()
  • B800120910 ()

  • Total Volume: 5 Milliliter
12091

  • Benzodiazepine group IVD, control

KeraStat Cream - B789P00210

Non-sterile, non-implantable wound dressing
Keranetics, Inc.
00
In Commercial Distribution

  • B789P00211 ()
  • B789P00210 ()

  • Total Volume: 5 Milliliter


  • Skin semi-occlusive dressing, non-antimicrobial

KeraStat Gel - B789P00100

Sterile, non-implantable, water-based gelatinous (hydrogel) wound dressing
Keranetics, Inc.
00
In Commercial Distribution

  • B789P00100 ()
  • B789P00101 ()

  • Total Volume: 5 Milliliter


  • Wound hydrogel dressing, non-antimicrobial
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