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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Reusable Thermometer Probe/20K/Adult/Skin/LP2单公/1.6M/郑州迪生
Unimed Medical Supplies, Inc.
TDS-16AS
In Commercial Distribution

  • 06945664856577 ()


  • General-purpose patient temperature probe, reusable
Nova StatStrip LAC Test Strips
NOVA BIOMEDICAL CORPORATION
STATSTRIP LAC
In Commercial Distribution

  • 20385480474867 ()
  • 10385480474860 ()
  • 00385480474863 ()
47486

  • Lactate IVD, control
Lactate Plus Lactate Test Strips
NOVA BIOMEDICAL CORPORATION
Lactate Plus
In Commercial Distribution

  • 20385480408138 ()
  • 10385480408131 ()
  • 00385480408134 ()
40813

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

  • 04015630926954 ()
5401666190

  • Lactate IVD, kit, spectrophotometry
No Description
Roche Diagnostics GmbH
3183700190
In Commercial Distribution

  • 04015630918911 ()
3183700190

  • 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
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
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
No Description
RANDOX LABORATORIES LIMITED
LC2389
In Commercial Distribution

  • 05055273204070 ()


  • Lactate IVD, kit, spectrophotometry
Lactate Standard (40 mg/dl)
TRINITY BIOTECH PUBLIC LIMITED COMPANY
826-10
Not in Commercial Distribution

  • 05391516742290 ()

  • Total Volume: 10 Milliliter
826-10

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

  • 00842768005398 ()
  • 00630414004440 ()
DF16

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

  • 00842768015243 ()
  • 00630414005171 ()
K3016

  • 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
Lactic Acid
ABBOTT LABORATORIES
9P18-21
In Commercial Distribution

  • 00380740121075 ()
09P1821

  • Lactate IVD, kit, reduction/oxidation
LA Cartridge, 10 count
Lifehealth
078770
In Commercial Distribution

  • 00856522006071 ()
  • 00856522006163 ()
070810

  • Lactate IVD, reagent
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