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 Class Implantable

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Lactate Plus Blood Lactate Measuring Meter Kit
NOVA BIOMEDICAL CORPORATION
Blood Lactate Measuring Meter
In Commercial Distribution

  • 10385480626245 ()
  • 00385480626248 ()
62624

  • Lactate monitoring system IVD, home-use
Stat Profile Ultra/CCX Lactate Membrane Kit
NOVA BIOMEDICAL CORPORATION
ULTRA/CCX
In Commercial Distribution

  • 00385480485548 ()
  • 00385489485549 ()
48554

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
StatStrip LAC Meter with Battery and Quick Reference Guide
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480474884 ()
  • 00385480474887 ()
47488

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Lactate Plus LAC Control 1
NOVA BIOMEDICAL CORPORATION
Lactate Plus
In Commercial Distribution

  • 00385480408158 ()
40815

  • Lactate IVD, control
STAT PROFILE pHOx PLUS L LACTATE MEMBRANE KIT
NOVA BIOMEDICAL CORPORATION
PHOX PLUS L
In Commercial Distribution

  • 10385480336236 ()
  • 00385480336239 ()
  • 00385489336230 ()
33623

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Stat Profile pHOx Ultra/CCX Lactate Sensor
NOVA BIOMEDICAL CORPORATION
ULTRA/CCX
In Commercial Distribution

  • 00385480485531 ()
48553

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Lactate Plus LAC Control 2
NOVA BIOMEDICAL CORPORATION
Lactate Plus
In Commercial Distribution

  • 00385480408141 ()
40814

  • Lactate IVD, control
STAT PROFILE pHOx PLUS L LACTATE SENSOR
NOVA BIOMEDICAL CORPORATION
PHOX PLUS L
In Commercial Distribution

  • 00385480336260 ()
33626

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
CARTRIDGE, CG4+
ABBOTT POINT OF CARE INC.
03P85-50
Not in Commercial Distribution

  • 10054749002266 ()
  • 00054749002269 ()
03P85-50

  • Blood gas/haemoximetry analyser IVD, point-of-care
  • Lactate electrode IVD
  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
CG4+ CARTRIDGE
ABBOTT POINT OF CARE INC.
03P85-25
In Commercial Distribution

  • 10054749000132 ()
  • 00054749000135 ()
03P85-25

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
  • Blood gas/haemoximetry analyser IVD, point-of-care
  • Lactate electrode IVD
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