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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No Description
APEX BIOTECHNOLOGY CORP.
The EDGE control solution
In Commercial Distribution

  • 04713648766554 ()


  • Lactate IVD, control
25s
APEX BIOTECHNOLOGY CORP.
The EDGE test strip
In Commercial Distribution

  • 04713648766547 ()


  • Lactate monitoring system IVD, home-use
KIT
APEX BIOTECHNOLOGY CORP.
The EDGE meter
In Commercial Distribution

  • 04713648766530 ()


  • Lactate monitoring system IVD, home-use
No Description
Hearts Bio, Inc.
TD-4289
In Commercial Distribution

  • 00850014861537 ()


  • Lactate IVD, reagent
No Description
Hearts Bio, Inc.
TD-4289
In Commercial Distribution

  • 00850014861407 ()


  • Lactate IVD, reagent
No Description
Hearts Bio, Inc.
TD-4289
In Commercial Distribution

  • 00850014861360 ()


  • Lactate IVD, reagent
Lactate_2 (Lac_2) Atellica CH - RGT 380T
Siemens Healthcare Diagnostics Inc.
11532568
Not in Commercial Distribution

  • 00630414287270 ()
11532568

  • Lactate IVD, kit, spectrophotometry
The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, FO2Hb, FCOHb, FMetHb, FHHb, nBili
Siemens Healthcare Diagnostics Inc.
10492730
In Commercial Distribution

  • 00630414589169 ()
10492730

  • Blood gas/haemoximetry analyser IVD, point-of-care
Lactate_3 (LAC_3) Atellica CH
Siemens Healthcare Diagnostics Inc.
11537218
In Commercial Distribution

  • 00630414305066 ()
  • 00630414610979 ()
11537218

  • Lactate IVD, kit, spectrophotometry
No Description
RANDOX LABORATORIES LIMITED
LC3980
In Commercial Distribution

  • 05055273204094 ()


  • Lactate IVD, kit, spectrophotometry
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