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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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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

Validity Control Level 2 - B800170110

Validity Control Level 2
UTAK LABORATORIES, INC.
17011
In Commercial Distribution

  • B800170110 ()
  • B800170115 ()

  • Total Volume: 25 Milliliter
17011

  • Multiple urine analyte 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

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

DAU CALIBRATOR LEVEL 2 - B80004240000020

No Description
UTAK LABORATORIES, INC.
DAU CAL 2 V4 F SEMCE
In Commercial Distribution

  • B80004240000020 ()
  • B80004240000021 ()
  • B80004240000022 ()
  • B80004240000023 ()
  • B80004240000026 ()
  • B80004240000027 ()
  • B80004240000028 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

CYSTATHIONINE PLUS LEVEL 2 - B80004000000020

No Description
UTAK LABORATORIES, INC.
CYST+ 2 LC
In Commercial Distribution

  • B80004000000020 ()
  • B80004000000021 ()
  • B80004000000022 ()
  • B80004000000023 ()
  • B80004000000026 ()
  • B80004000000027 ()
  • B80004000000028 ()


  • Multiple vitamin IVD, control

BUPRENORPHINE PLUS LEVEL 2 - B80003716500060

BUPRENORPHINE PLUS LEVEL 2
UTAK LABORATORIES, INC.
BUP+ 2 U PM
In Commercial Distribution

  • B80003716500061 ()
  • B80003716500060 ()
  • B80003716500062 ()
  • B80003716500063 ()
  • B80003716500066 ()
  • B80003716500067 ()
  • B80003716500068 ()


  • Opiate/opiate metabolite IVD, control

ALPRAZOLAM PLUS LEVEL 2 - B800ALP2V2UFLENCO0

ALPRAZOLAM PLUS LEVEL 2
UTAK LABORATORIES, INC.
ALP+ 2 V2 U F LENCO
In Commercial Distribution

  • B800ALP2V2UFLENCO5 ()
  • B800ALP2V2UFLENCO0 ()

  • Total Volume: 2.5 Milliliter
ALP+ 2 V2 U F LENCO

  • Multiple-type clinical chemistry analyte profile IVD, control

AED LEVEL 2 V2 - B800AED2V2SHCMC0

AED LEVEL 2 V2
UTAK LABORATORIES, INC.
AED 2 V2 S HCMC
In Commercial Distribution

  • B800AED2V2SHCMC5 ()
  • B800AED2V2SHCMC0 ()

  • Total Volume: 3 Milliliter
AED 2 V2 S HCMC

  • Multiple-type clinical chemistry analyte profile IVD, control

SSRI 12 LEVEL 2 - B80092021IDC0

SSRI 12 LEVEL 2
UTAK LABORATORIES, INC.
92021 IDC
In Commercial Distribution

  • B80092021IDC5 ()
  • B80092021IDC0 ()

  • Total Volume: 3 Milliliter
92021 IDC

  • Multiple-type clinical chemistry analyte profile IVD, control
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