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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Lactic Acid Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444961
In Commercial Distribution

  • 00842768005398 ()
  • 00630414004440 ()
DF16

  • Lactate IVD, kit, spectrophotometry
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
Roche Diagnostics GmbH
5171881190
In Commercial Distribution

  • 04015630925148 ()
5171881190

  • Lactate IVD, kit, spectrophotometry
No Description
Roche Diagnostics GmbH
5401666190
In Commercial Distribution

  • 04015630926954 ()
5401666190

  • Lactate IVD, kit, spectrophotometry
No Description
Roche Diagnostics GmbH
3260933184
In Commercial Distribution

  • 04015630018178 ()
3260933184

  • Multiple blood gas analyte IVD, reagent
No Description
Roche Diagnostics GmbH
03260887184
In Commercial Distribution

  • 04015630018130 ()
03260887184

  • Multiple blood gas analyte IVD, reagent
No Description
Roche Diagnostics GmbH
3183700190
In Commercial Distribution

  • 04015630918911 ()
3183700190

  • Lactate IVD, kit, spectrophotometry
VITROS Chemistry Products LAC Slides
ORTHO-CLINICAL DIAGNOSTICS, INC.
8433880
In Commercial Distribution

  • 10758750004911 ()
8433880

  • Lactate IVD, reagent
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