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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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VITROS Immunodiagnostic Products HIV Combo Controls (HIV p24 Antigen)
ORTHO CLINICAL DIAGNOSTICS
691 2263
In Commercial Distribution

  • 10758750033171 ()
  • 20758750033178 ()
691 2263

  • HIV1 antigen IVD, control
VITROS Immunodiagnostic Products BRAHMS PCT Range Verifiers
ORTHO CLINICAL DIAGNOSTICS
6905561
In Commercial Distribution

  • 10758750032945 ()
  • 20758750032942 ()
6905561

  • Procalcitonin (PCT) IVD, control
VITROS Immunodiagnostic Products BRAHMS PCT Controls
ORTHO CLINICAL DIAGNOSTICS
6905560
In Commercial Distribution

  • 10758750032938 ()
  • 20758750032935 ()
6905560

  • Procalcitonin (PCT) IVD, control
VITROS Immunodiagnostic Products NT-proBNP II Controls
ORTHO CLINICAL DIAGNOSTICS
6844507
In Commercial Distribution

  • 10758750032099 ()
  • 20758750032096 ()
6844507

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products CK-MB Calibrators
ORTHO CLINICAL DIAGNOSTICS
1286293
In Commercial Distribution

  • 10758750008728 ()
  • 20758750008725 ()
1286293

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay
Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination.
BIOMERIEUX SA
ETEST® Ceftaroline (CPT)
In Commercial Distribution

  • 03573026261658 ()
  • 03573026548568 ()
  • 03573026547509 ()


  • Antibacterial minimum inhibitory concentration (MIC) IVD
Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination.
BIOMERIEUX SA
Etest® TIGECYCLINE
In Commercial Distribution

  • 03573026260866 ()
  • 03573026548186 ()
  • 03573026547295 ()


  • Antibacterial minimum inhibitory concentration (MIC) IVD
Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination.
BIOMERIEUX SA
Etest® TOBRAMYCIN
In Commercial Distribution

  • 03573026254490 ()
  • 03573026548131 ()
  • 03573026547271 ()


  • Antibacterial minimum inhibitory concentration (MIC) IVD
Etest is a quantitative technique for determining the MIC of antimicrobial agents against microorganisms and for detection of resistance mechanisms.
BIOMERIEUX SA
ETEST® ESBL Ceftazidime/ceftazidime + clavulanic acid (TZ/TZL)
In Commercial Distribution

  • 03573026256760 ()
  • 03573026548117 ()
  • 03573026547264 ()
  • 03573026256999 ()
  • 03573026548124 ()


  • Antibacterial minimum inhibitory concentration (MIC) IVD
Etest is a quantitative technique for determining the MIC of antimicrobial agents against microorganisms and for detection of resistance mechanisms.
BIOMERIEUX SA
ETEST® ESBL Cefotaxime/cefotaxime + clavulanic acid (CT/CTL)
In Commercial Distribution

  • 03573026256753 ()
  • 03573026548094 ()
  • 03573026547257 ()
  • 03573026256982 ()
  • 03573026548100 ()


  • Antibacterial minimum inhibitory concentration (MIC) IVD
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