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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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Validity Control Level 1
UTAK LABORATORIES, INC.
17010
In Commercial Distribution

  • B800170100 ()
  • B800170105 ()

  • Total Volume: 25 Milliliter
17010

  • Multiple urine analyte IVD, control
ETG Plus Level 2
UTAK LABORATORIES, INC.
13021
In Commercial Distribution

  • B800130215 ()
  • B800130210 ()

  • Total Volume: 5 Milliliter
13021

  • Ethyl glucuronide (EtG) IVD, control
ETG Plus Level 1
UTAK LABORATORIES, INC.
13020
In Commercial Distribution

  • B800130205 ()
  • B800130200 ()

  • Total Volume: 5 Milliliter
13020

  • Ethyl glucuronide (EtG) IVD, control
NR Urine Metals
UTAK LABORATORIES, INC.
12111
In Commercial Distribution

  • B800121115 ()
  • B800121110 ()

  • Total Volume: 5 Milliliter
12111

  • Multiple heavy metal IVD, control
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
UTAK LABORATORIES, INC.
12106
In Commercial Distribution

  • B800121065 ()
  • B800121060 ()

  • Total Volume: 5 Milliliter
12106

  • Methotrexate therapeutic drug monitoring IVD, control
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
UTAK LABORATORIES, INC.
12104
In Commercial Distribution

  • B800121045 ()
  • B800121040 ()

  • Total Volume: 5 Milliliter
12104

  • Methotrexate therapeutic drug monitoring IVD, control
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
UTAK LABORATORIES, INC.
12100
In Commercial Distribution

  • B800121005 ()
  • B800121000 ()

  • Total Volume: 5 Milliliter
12100

  • Benzodiazepine group IVD, control
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