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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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Liofilchem MIC Test Strip (MTS) - 08055182870110

MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Meropenem 0.002-32 μg/mL are porous strips impregnated with a predefined concentration gradient of meropenem for susceptibility testing of E. coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa
LIOFILCHEM SRL
Meropenem 0.002-32 μg/mL 10 strip
In Commercial Distribution

  • 18055182870117 ()
  • 08055182870110 ()
  • 08055182870097 ()
$92084-10

  • Meropenem minimum inhibitory concentration (MIC) IVD

Liofilchem MIC Test Strip (MTS) - 08055182870103

MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Meropenem 0.002-32 μg/mL are porous strips impregnated with a predefined concentration gradient of meropenem for susceptibility testing of E. coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa
LIOFILCHEM SRL
Meropenem 0.002-32 μg/mL 1 strip
In Commercial Distribution

  • 28055182870107 ()
  • 08055182870103 ()
  • 18055182870100 ()
$92084-1

  • Meropenem minimum inhibitory concentration (MIC) IVD

Liofilchem MIC Test Strip (MTS) - 08055182870080

MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Ceftolozane/Tazobactam 0.016/4 – 256/4 μg/mL are specialized strips impregnated with a predefined concentration gradient of ceftolozane/tazobactam for susceptibility testing of Enterobacter cloacae, E. coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa.
LIOFILCHEM SRL
Ceftolozane/Tazobactam 0.016/4 – 256/4 µg/mL 10 strips
In Commercial Distribution

  • 18055182870087 ()
  • 08055182870080 ()
  • 08055182870066 ()
$92146-10

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

Liofilchem MIC Test Strip (MTS) - 08055182870073

MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Ceftolozane/Tazobactam 0.016/4 – 256/4 μg/mL are specialized strips impregnated with a predefined concentration gradient of ceftolozane/tazobactam for susceptibility testing of Enterobacter cloacae, E. coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa
LIOFILCHEM SRL
Ceftolozane/Tazobactam 0.016/4 – 256/4 µg/mL 1 strip
In Commercial Distribution

  • 28055182870077 ()
  • 08055182870073 ()
  • 18055182870070 ()
$92146-1

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

VITROS - 10758750034642

VITROS Immunodiagnostic Products CK-MB Calibrators
ORTHO CLINICAL DIAGNOSTICS
6199329
In Commercial Distribution

  • 10758750034642 ()
  • 20758750034649 ()
6199329

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay

VITROS - 10758750034581

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators
ORTHO-CLINICAL DIAGNOSTICS, INC.
6199976
In Commercial Distribution

  • 10758750034581 ()
6199976

  • SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay

VITROS - 10758750034420

VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Calibrator
ORTHO CLINICAL DIAGNOSTICS
6199961
In Commercial Distribution

  • 10758750034420 ()
6199961

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

VITROS - 10758750033591

VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator
ORTHO-CLINICAL DIAGNOSTICS, INC.
6199950
In Commercial Distribution

  • 10758750033591 ()
6199950

  • SARS-CoV-2 antigen IVD, kit, chemiluminescent immunoassay

VITROS - 10758750032945

VITROS Immunodiagnostic Products BRAHMS PCT Range Verifiers
ORTHO CLINICAL DIAGNOSTICS
6905561
In Commercial Distribution

  • 10758750032945 ()
  • 20758750032942 ()
6905561

  • Procalcitonin (PCT) IVD, control

VITROS - 10758750032938

VITROS Immunodiagnostic Products BRAHMS PCT Controls
ORTHO CLINICAL DIAGNOSTICS
6905560
In Commercial Distribution

  • 10758750032938 ()
  • 20758750032935 ()
6905560

  • Procalcitonin (PCT) IVD, control
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