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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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I-STAT TBI Calibration Verification Set
ABBOTT POINT OF CARE INC.
06P17-24
In Commercial Distribution

  • 00054749004959 ()


  • Multiple traumatic brain injury marker IVD, control
i-STAT hs-TnI Control Level 3
Abbott Point of Care Inc.
06P17-23
In Commercial Distribution

  • 00054749004942 ()
06P17-23

  • Troponin I IVD, control
i-STAT hs-TnI Control Level 2
Abbott Point of Care Inc.
06P17-22
In Commercial Distribution

  • 00054749004935 ()
06P17-22

  • Troponin I IVD, control
i-STAT hs-TnI Control Level 1
Abbott Point of Care Inc.
06P17-21
In Commercial Distribution

  • 00054749004928 ()
06P17-21

  • Troponin I IVD, control
i-STAT hs-TnI Calibration Verification, Levels 1-3
Abbott Point of Care Inc.
06P17-20
In Commercial Distribution

  • 00054749004911 ()
06P17-20

  • Troponin I IVD, control
USA Elite System Continuous Flow Resectoscope Outer Sheath, Raised Tip 25.6 Fr, (8.5 mm) Color Coded Yellow
Gyrus ACMI, LLC
EOS-CFR-25
In Commercial Distribution

  • 00821925002074 ()


  • General-purpose endoscopic needle, reusable
MIC Tests Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Ceftazidime-avibactam 0.016/4 – 256 /4 µg/mL are specialized strips impregnated with a predefined concentration gradient of Ceftazidime and Avibactam for susceptibility testing of Citrobacter freundii, Enterobacter cloacae, Escherichia Coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis and Pseudomonas aeruginosa.
LIOFILCHEM SRL
Ceftazidime-Avibactam 0.016/4-256/4 10 Stripsµg/mL
In Commercial Distribution

  • 18055182873354 ()
  • 08055182873357 ()
  • 08055182873333 ()
$92139-10

  • Ceftazidime/avibactam minimum inhibitory concentration (MIC) IVD
MIC Tests Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Ceftazidime-avibactam 0.016/4 – 256 /4 µg/mL are specialized strips impregnated with a predefined concentration gradient of Ceftazidime and Avibactam for susceptibility testing of Citrobacter freundii, Enterobacter cloacae, Escherichia Coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis and Pseudomonas aeruginosa.
LIOFILCHEM SRL
Ceftazidime-Avibactam 0.016/4-256/4 µg/mL 1 Strip
In Commercial Distribution

  • 28055182873344 ()
  • 08055182873340 ()
  • 18055182873347 ()
$92139-1

  • Ceftazidime/avibactam 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-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
No Description
LIOFILCHEM SRL
Omadacycline 0.002-32 µg/mL, 10 Strip
In Commercial Distribution

  • 18055182872395 ()
  • 08055182872398 ()
  • 08055182872374 ()
$92071-10

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