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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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ANTIFUNGALS LEVEL 2
UTAK LABORATORIES, INC.
A-FUNG L2 S F UW
In Commercial Distribution

  • B800AFUNGL2SFUW5 ()
  • B800AFUNGL2SFUW0 ()

  • Total Volume: 2 Milliliter
A-FUNG L2 S F UW

  • Multiple drugs of abuse IVD, control
ANTIFUNGALS LEVEL 2
UTAK LABORATORIES, INC.
A-FUNG L2 S F MAYO
In Commercial Distribution

  • B800AFUNGL2SFMAYO5 ()
  • B800AFUNGL2SFMAYO0 ()

  • Total Volume: 0.5 Milliliter
A-FUNG L2 S F MAYO

  • Multiple-therapy therapeutic drug monitoring IVD, control
ANTIFUNGALS LEVEL 1
UTAK LABORATORIES, INC.
A-FUNG L1 S F UW
In Commercial Distribution

  • B800AFUNGL1SFUW6 ()
  • B800AFUNGL1SFUW0 ()

  • Total Volume: 2 Milliliter
A-FUNG L1 S F UW

  • Multiple drugs of abuse IVD, control
ANTIFUNGALS LEVEL 1
UTAK LABORATORIES, INC.
A-FUNG L1 S F MAYO
In Commercial Distribution

  • B800AFUNGL1SFMAYO5 ()
  • B800AFUNGL1SFMAYO0 ()

  • Total Volume: 0.5 Milliliter
A-FUNG L1 S F MAYO

  • Multiple-therapy therapeutic drug monitoring IVD, control
ADS/APS CONTROL SOLUTION V3
UTAK LABORATORIES, INC.
ADS/APSV3CONTFCCO
In Commercial Distribution

  • B800ADSAPSV3CONTFCCO5 ()
  • B800ADSAPSV3CONTFCCO0 ()

  • Total Volume: 25 Milliliter
ADS/APSV3CONTFCCO

  • Multiple-therapy therapeutic drug monitoring IVD, control
ACID PLUS
UTAK LABORATORIES, INC.
ACID+ M TCME
In Commercial Distribution

  • B800ACIDMTCME0 ()
  • B800ACIDMTCME5 ()

  • Total Volume: 50 Milliliter
ACID+ M TCME

  • Multiple-type clinical chemistry analyte profile IVD, control
ACETAMINOPHEN PLUS 2
UTAK LABORATORIES, INC.
ACETA+ V3 2 S F BD
In Commercial Distribution

  • B800ACETAV32SFBD5 ()
  • B800ACETAV32SFBD0 ()

  • Total Volume: 4 Milliliter
ACETA+ V3 2 S F BD

  • Multiple drugs of abuse IVD, control
ACCURUN 119 Anti-Hepatitis B e Antigen 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0072
In Commercial Distribution

  • 00816784020307 ()
2015-0072

  • Hepatitis B virus e-antigen IVD, control
ACCURUN 117 Hepatitis B e Antigen 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0071
In Commercial Distribution

  • 00816784020291 ()
2015-0071

  • Hepatitis B virus e-antigen IVD, control
ACCURUN 51 Multi-Marker Hepatitis 1 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0041
In Commercial Distribution

  • 00816784020192 ()
2000-0041

  • Hepatitis B virus antigen/antibody marker IVD, control
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