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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 LEVEL 2 - B800AMPH2UKP0

AMPHETAMINES LEVEL 2
UTAK LABORATORIES, INC.
AMPH 2 U KP
In Commercial Distribution

  • B800AMPH2UKP5 ()
  • B800AMPH2UKP0 ()

  • Total Volume: 3 Milliliter
AMPH 2 U KP

  • Multiple drugs of abuse IVD, control

ALDOSTERONE LEVEL 2 - B800ALDO2FUVHS0

ALDOSTERONE LEVEL 2
UTAK LABORATORIES, INC.
ALDO 2 F UVHS
In Commercial Distribution

  • B800ALDO2FUVHS0 ()

  • Total Volume: 10 Milliliter
ALDO 2 F UVHS

  • Multiple-type clinical chemistry analyte profile IVD, control

DAU LC 2 - B800507030

DAU LC 2
UTAK LABORATORIES, INC.
50703
In Commercial Distribution

  • B800507035 ()
  • B800507030 ()

  • Total Volume: 10 Milliliter
50703

  • Multiple drugs of abuse IVD, control

DAU HC 2 - B800507010

DAU HC 2
UTAK LABORATORIES, INC.
50701
In Commercial Distribution

  • B800507015 ()
  • B800507010 ()

  • Total Volume: 10 Milliliter
50701

  • Multiple drugs of abuse IVD, control

DAU IA 2 - B800506010

DAU IA 2
UTAK LABORATORIES, INC.
50601
In Commercial Distribution

  • B800506015 ()
  • B800506010 ()

  • Total Volume: 10 Milliliter
50601

  • Multiple drugs of abuse IVD, control

Metals Level 2 - B800445220

Metals Level 2
UTAK LABORATORIES, INC.
44522
In Commercial Distribution

  • B800445225 ()
  • B800445220 ()

  • Total Volume: 3 Milliliter
44522

  • Multiple heavy metal IVD, control

Antifungals Level 2 - B800430110

Antifungals Level 2
UTAK LABORATORIES, INC.
43011
In Commercial Distribution

  • B800430115 ()
  • B800430110 ()

  • Total Volume: 5 Milliliter
43011

  • Multiple antifungal therapeutic drug monitoring IVD, control

ORTHOLOC™ 2 - 00889797076869

Joint Prep Instrument Kit
WRIGHT MEDICAL TECHNOLOGY, INC.
9914PK01
In Commercial Distribution

  • 00889797076869 ()
9914PK01

  • Orthopaedic surgical procedure kit, non-medicated, single-use

Immunosuppressants Level 2 - B800416310

Immunosuppressants Level 2
UTAK LABORATORIES, INC.
41631
In Commercial Distribution

  • B800416315 ()
  • B800416310 ()

  • Total Volume: 3 Milliliter
41631

  • Multiple immunosuppressant therapeutic drug monitoring IVD, control

DEXAMETHASONE LEVEL 2 - B800201980

DEXAMETHASONE LEVEL 2
UTAK LABORATORIES, INC.
20198
In Commercial Distribution

  • B800201985 ()
  • B800201980 ()

  • Total Volume: 3 Milliliter
20198

  • Multiple steroid hormone IVD, control
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