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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 SRL
Imipenem IMI 0.016-256 µg/ml 10 Strip
In Commercial Distribution

  • 18055182872302 ()
  • 08055182872305 ()
  • 08055182872282 ()
$92068-10

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit
No Description
LIOFILCHEM SRL
Imipenem IMI 0.016-256 µg/ml, 1 Strip
In Commercial Distribution

  • 28055182872293 ()
  • 08055182872299 ()
  • 18055182872296 ()
$92068-1

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit
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-vaborbactam M/V 0.016/8 - 256/8 are specialized strips impregnated with a predefined concentration gradient of Meropenem-vaborbactam for susceptibility testing of Enterobacter cloacae species complex, Escherichia coli, Klebsiella pneumoniae
LIOFILCHEM SRL
Meropenem-vaborbactam M/V 0.016/8 - 256/8 - 10 strips
In Commercial Distribution

  • 18055182870322 ()
  • 08055182870325 ()
  • 08055182870301 ()
$92074-10

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit
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-vaborbactam M/V 0.016/8 - 256/8 are specialized strips impregnated with a predefined concentration gradient of Meropenem-vaborbactam for susceptibility testing of Enterobacter cloacae species complex, Escherichia coli, Klebsiella pneumoniae
LIOFILCHEM SRL
Meropenem-vaborbactam M/V 0.016/8 - 256/8 - 1 strip
In Commercial Distribution

  • 28055182870312 ()
  • 08055182870318 ()
  • 18055182870315 ()
$92074-1

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit
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
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
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
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 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 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 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 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 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
VITROS Immunodiagnostic Products Troponin I ES Calibrators
ORTHO CLINICAL DIAGNOSTICS
6802302
In Commercial Distribution

  • 10758750002511 ()
  • 20758750002518 ()
6802302

  • Troponin I 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
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® ERTAPENEM
In Commercial Distribution

  • 03573026260439 ()
  • 03573026548049 ()
  • 03573026547226 ()


  • 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® Fosfomycin (FM)
In Commercial Distribution

  • 03573026256739 ()
  • 03573026547981 ()
  • 03573026547196 ()
  • 03573026256951 ()
  • 03573026547998 ()


  • 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® MEROPENEM
In Commercial Distribution

  • 03573026259280 ()
  • 03573026547677 ()
  • 03573026546984 ()
  • 03573026259297 ()
  • 03573026547684 ()


  • 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® Gentamicin (GM)
Not in Commercial Distribution

  • 03573026256685 ()
  • 03573026547646 ()
  • 03573026546960 ()


  • 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® CEFOTETAN
In Commercial Distribution

  • 03573026262112 ()
  • 03573026547592 ()
  • 03573026546939 ()


  • Antibacterial minimum inhibitory concentration (MIC) IVD
AIMGEN MAX Internal Fixture Φ3.2/L14.5
Achimhai Medical Corporation
KM3015SA
In Commercial Distribution

  • 08800024953373 ()
MFX-3015S-CA

  • Screw endosteal dental implant, two-piece
AIMGEN MAX Internal Fixture Φ3.2/L9.5
Achimhai Medical Corporation
KM3010SA
In Commercial Distribution

  • 08800024953298 ()
MFX-3010S-CA

  • Screw endosteal dental implant, two-piece
Fixture Φ3.2/L9.5
Achimhai Medical Corporation
I3210-SH
In Commercial Distribution

  • 08800024913711 ()
I3210-SH

  • Screw endosteal dental implant, two-piece
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