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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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High Range SSRI 7 Plus - B800570400

HR SSRI 7 Plus
UTAK LABORATORIES, INC.
57040
In Commercial Distribution

  • B800570405 ()
  • B800570400 ()

  • Total Volume: 5 Milliliter
57040

  • Multiple antidepressant therapeutic drug monitoring IVD, control

Antifungals Level 1 - B800430100

Antifungals Level 1
UTAK LABORATORIES, INC.
43010
In Commercial Distribution

  • B800430105 ()
  • B800430100 ()

  • Total Volume: 5 Milliliter
43010

  • Multiple antifungal therapeutic drug monitoring IVD, control

Miscellaneous Panel Level 2 - B800414310

Miscellaneous Panel Level 2
UTAK LABORATORIES, INC.
41431
In Commercial Distribution

  • B800414315 ()
  • B800414310 ()

  • Total Volume: 5 Milliliter
41431

  • Multiple drugs of abuse IVD, control

Miscellaneous Panel Level 1 - B800414300

Miscellaneous Panel Level 1
UTAK LABORATORIES, INC.
41430
In Commercial Distribution

  • B800414305 ()
  • B800414300 ()

  • Total Volume: 5 Milliliter
41430

  • Multiple drugs of abuse IVD, control

Amphetamines Panel Level 2 - B800414010

Amphetamines Panel Level 2
UTAK LABORATORIES, INC.
41401
In Commercial Distribution

  • B800414015 ()
  • B800414010 ()

  • Total Volume: 5 Milliliter
41401

  • Amphetamine/methamphetamine group IVD, control

Amphetamines Panel Level 1 - B800414000

Amphetamines Panel Level 1
UTAK LABORATORIES, INC.
41400
In Commercial Distribution

  • B800414005 ()
  • B800414000 ()

  • Total Volume: 5 Milliliter
41400

  • Amphetamine/methamphetamine group IVD, control

Pain Management 100 - B800210800

PM 100 (Pain Management)
UTAK LABORATORIES, INC.
21080
In Commercial Distribution

  • B800210805 ()
  • B800210800 ()

  • Total Volume: 5 Milliliter
21080

  • Opiate/opiate metabolite IVD, control

Pain Management 100 - B800210700

PM 100(Pain Management)
UTAK LABORATORIES, INC.
21070
In Commercial Distribution

  • B800210705 ()
  • B800210700 ()

  • Total Volume: 5 Milliliter
21070

  • Opiate/opiate metabolite IVD, control

ETG Plus Level 2 - B800130210

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 - B800130200

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

  • B800130205 ()
  • B800130200 ()

  • Total Volume: 5 Milliliter
13020

  • Ethyl glucuronide (EtG) IVD, control
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