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 Acid2 400 Tests
ABBOTT IRELAND
04T3020
In Commercial Distribution

  • 00380740158392 ()
04T3020

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

  • 00842768005398 ()
  • 00630414004440 ()
DF16

  • Lactate IVD, kit, spectrophotometry
No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:18mL×4 R2:6mL×4
In Commercial Distribution

  • 06971674866763 ()


  • Lactate IVD, reagent
No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:18mL×1 R2:6mL×1
In Commercial Distribution

  • 06971674866770 ()


  • Lactate IVD, reagent
No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:60mL×2 R2:20mL×2
In Commercial Distribution

  • 06971674866756 ()


  • Lactate IVD, reagent
No Description
Roche Diagnostics GmbH
08057940190
In Commercial Distribution

  • 07613336121351 ()
08057940190

  • Lactate IVD, kit, spectrophotometry
Lactate
Beckman Coulter, Inc.
OSR6193
In Commercial Distribution

  • 15099590010898 ()


  • Lactate IVD, kit, spectrophotometry
Lactate Test Strip
FORA CARE INC.
Test N'GO Advance Voice
In Commercial Distribution

  • 80816042014549 ()
  • 00816042014543 ()


  • Lactate monitoring system IVD, home-use
Lactate Test System
FORA CARE INC.
Test N'GO Advance Voice
In Commercial Distribution

  • 00816042014505 ()


  • Lactate monitoring system IVD, home-use
Cartridge, CG4+
ABBOTT POINT OF CARE INC.
03P85-51
In Commercial Distribution

  • 00054749005505 ()
  • 10054749005502 ()
03P85-51

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
NOVA GLU/LAC SENSOR SOAKING SOLUTION
NOVA BIOMEDICAL CORPORATION
1
In Commercial Distribution

  • 00385480134095 ()
13409

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
StatStrip Docking Station Remanufactured 4 position 1.75
NOVA BIOMEDICAL CORPORATION
1.75
In Commercial Distribution

  • 10385480560372 ()
  • 00385480560375 ()
56037

  • Glucose monitoring system IVD, point-of-care
StatStrip Docking Station Remanufactured 2 position 1.75
NOVA BIOMEDICAL CORPORATION
1.75
In Commercial Distribution

  • 10385480560365 ()
  • 00385480560368 ()
56036

  • Glucose monitoring system IVD, point-of-care
StatStrip StatSensor Remanufactured Wireless Carrying Case for Meter and Supplies v1.0
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480544228 ()
  • 00385480544221 ()
54422

  • Glucose monitoring system IVD, point-of-care
StatStrip StatSensor Remanufactured Wireless Carrying Case for Meter and Supplies
NOVA BIOMEDICAL CORPORATION
1.75
In Commercial Distribution

  • 10385480544198 ()
  • 00385480544191 ()
54419

  • Glucose monitoring system IVD, point-of-care
StatStrip StatSensor Wireless Carrying Case for Meter and Supplies
NOVA BIOMEDICAL CORPORATION
1.75
In Commercial Distribution

  • 10385480534397 ()
  • 00385480534390 ()
53439

  • Glucose monitoring system IVD, point-of-care
StatStrip StatSensor Docking Station
NOVA BIOMEDICAL CORPORATION
1.75
In Commercial Distribution

  • 10385480534021 ()
  • 00385480534024 ()
53402

  • Glucose monitoring system IVD, point-of-care
StatStrip StatSensor Docking Station
NOVA BIOMEDICAL CORPORATION
1.75
In Commercial Distribution

  • 10385480534014 ()
  • 00385480534017 ()
53401

  • Glucose monitoring system IVD, point-of-care
StatStrip StatSensor Docking Station
NOVA BIOMEDICAL CORPORATION
1.75
In Commercial Distribution

  • 10385480534007 ()
  • 00385480534000 ()
53400

  • Glucose monitoring system IVD, point-of-care
Statsensor Statstrip Docking Station 4 position
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480519967 ()
  • 00385480519960 ()
51996

  • Glucose monitoring system IVD, point-of-care
Statsensor Statstrip Docking Station 2 position
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480519950 ()
  • 00385480519953 ()
51995

  • Glucose monitoring system IVD, point-of-care
Statsensor Statstrip Docking Station
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480519943 ()
  • 00385480519946 ()
51994

  • Glucose monitoring system IVD, point-of-care
StatSensor StatStrip Docking Station Remanufactured
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480517567 ()
  • 00385480517560 ()
51756

  • Glucose monitoring system IVD, point-of-care
StatSensor StatStrip Wireless Carrying Case for Meter and Supplies
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480486306 ()
  • 00385480486309 ()
48630

  • Glucose monitoring system IVD, point-of-care
StatSensor StatStrip Docking Station for Wireless Carrying Case
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480486290 ()
  • 00385480486293 ()
48629

  • Glucose monitoring system IVD, point-of-care
StatSensor Stat Strip Docking Station Non Network Capable
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480438060 ()
  • 00385480438063 ()
43806

  • Glucose monitoring system IVD, point-of-care
StatSensor StatStrip Docking Station
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480422250 ()
  • 00385480422253 ()
42225

  • Glucose monitoring system IVD, point-of-care
No Description
Epocal Inc
HR-1R04-00-00
In Commercial Distribution

  • 00809708116712 ()
HR-1R04-00-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-1009-CN-ZH
In Commercial Distribution

  • 00809708097219 ()
HH-1009-CN-ZH

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-1R09-JP-JP
In Commercial Distribution

  • 00809708075583 ()
HH-1R09-JP-JP

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-1009-JP-JP
In Commercial Distribution

  • 00809708075576 ()
HH-1009-JP-JP

  • Metabolic profile clinical chemistry analyser IVD
EPOC BGEM CREA TEST CARD
Epocal Inc
CT-1006-00-00
In Commercial Distribution

  • 00809708072254 ()
CT-1006-00-00

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
No Description
Epocal Inc
HH-1R09-CA-00
In Commercial Distribution

  • 00809708069124 ()
HH-1R09-CA-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-1009-CA-00
In Commercial Distribution

  • 00809708069117 ()
HH-1009-CA-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-0R03-CA-00
In Commercial Distribution

  • 00809708064068 ()
HH-0R03-CA-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-0R05-CA-00
In Commercial Distribution

  • 00809708064051 ()
HH-0R05-CA-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-0005-CA-00
In Commercial Distribution

  • 00809708064044 ()
HH-0005-CA-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-0010-JP-JP
In Commercial Distribution

  • 00809708055899 ()
HH-0010-JP-JP

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-1R09-00-00
In Commercial Distribution

  • 00809708053901 ()
HH-1R09-00-00

  • Metabolic profile clinical chemistry analyser IVD
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