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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VITROS Chemistry Products LAC Slides
ORTHO-CLINICAL DIAGNOSTICS, INC.
8433880
In Commercial Distribution

  • 10758750004911 ()
8433880

  • Lactate IVD, reagent
VITROS Chemistry Products LAC Slides
ORTHO-CLINICAL DIAGNOSTICS, INC.
8150112
In Commercial Distribution

  • 10758750004454 ()
8150112

  • Lactate IVD, reagent
No Description
Roche Diagnostics GmbH
5171881190
In Commercial Distribution

  • 04015630925148 ()
5171881190

  • Lactate IVD, kit, spectrophotometry
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
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
RANDOX LABORATORIES LIMITED
LC3980
In Commercial Distribution

  • 05055273204094 ()


  • Lactate IVD, kit, spectrophotometry
No Description
RANDOX LABORATORIES LIMITED
LC2389
In Commercial Distribution

  • 05055273204070 ()


  • Lactate IVD, kit, spectrophotometry
Lactic Acid
ABBOTT LABORATORIES
9P18-21
In Commercial Distribution

  • 00380740121075 ()
09P1821

  • Lactate IVD, kit, reduction/oxidation
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
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
Lactic Acid Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10445153
In Commercial Distribution

  • 00842768015243 ()
  • 00630414005171 ()
K3016

  • Lactate IVD, kit, spectrophotometry
Lactic Acid Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444961
In Commercial Distribution

  • 00842768005398 ()
  • 00630414004440 ()
DF16

  • Lactate IVD, kit, spectrophotometry
Alinity c Lactic Acid Reagent Kit 1000 Tests
Abbott GmbH
08P2121
In Commercial Distribution

  • 00380740179199 ()
08P2121

  • Lactate IVD, kit, reduction/oxidation
Lactic Acid2 400 Tests
ABBOTT IRELAND
04U2620
In Commercial Distribution

  • 00380740158408 ()
04U2620

  • Lactate IVD, kit, spectrophotometry
Lactic Acid2 400 Tests
ABBOTT IRELAND
04T3020
In Commercial Distribution

  • 00380740158392 ()
04T3020

  • Lactate IVD, kit, spectrophotometry
Alinity c Lactic Acid Reagent Kit 1000 Tests
Abbott GmbH
08P2120
In Commercial Distribution

  • 00380740135232 ()
08P2120

  • Lactate IVD, kit, reduction/oxidation
Lactate_3 (LAC_3) Atellica CH
Siemens Healthcare Diagnostics Inc.
11537218
In Commercial Distribution

  • 00630414305066 ()
  • 00630414610979 ()
11537218

  • Lactate IVD, kit, spectrophotometry
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