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 Size Type Device Class Implantable

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Na/K/Cl/Li Solution Pack for use with EasyLyte Analyzers
MEDICA CORPORATION
2026
In Commercial Distribution

  • 00386100002916 ()
2026

  • Multiple electrolyte IVD, calibrator
ISE Reagent Module for use with EasyElectrolyte Analyzers
MEDICA CORPORATION
5425-0000
In Commercial Distribution

  • 00386100002831 ()
5425-0000

  • Multiple electrolyte IVD, calibrator
ISE Reagent Pack for use with EasyElectrolyte Analyzers
MEDICA CORPORATION
5420-0000
In Commercial Distribution

  • 00386100002817 ()
5420-0000

  • Multiple electrolyte IVD, calibrator
EasyStat Reagent Module
MEDICA CORPORATION
7101-0000
In Commercial Distribution

  • 00386100002664 ()
7101-0000

  • Multiple electrolyte IVD, calibrator
EasyElectrolyte Reagent Module for Na/K/Li Analyzers
MEDICA CORPORATION
4103-0000
In Commercial Distribution

  • 00386100002558 ()
4103-0000

  • Multiple electrolyte IVD, calibrator
EasyElectrolyte Reagent Module for Na/K/Cl Analyzers
MEDICA CORPORATION
4102-0000
In Commercial Distribution

  • 00386100002541 ()
4102-0000

  • Multiple electrolyte IVD, calibrator
ISE Reagent Pack for use with EasyRA Analyzers
MEDICA CORPORATION
5423-0041
In Commercial Distribution

  • 00386100002282 ()
5423-0041

  • Multiple electrolyte IVD, calibrator
No Description
TOKYO BOEKI MEDISYS INC.
30-27-0905
In Commercial Distribution

  • 04580262040076 ()
30-27-0905

  • Multiple electrolyte IVD, calibrator
No Description
TOKYO BOEKI MEDISYS INC.
60-22-0263
In Commercial Distribution

  • 04580262016019 ()
60-22-0263

  • Multiple electrolyte IVD, calibrator
No Description
TOKYO BOEKI MEDISYS INC.
20-27-0483
In Commercial Distribution

  • 04580262010352 ()
20-27-0483

  • Multiple electrolyte IVD, calibrator
No Description
TOKYO BOEKI MEDISYS INC.
20-27-0480
In Commercial Distribution

  • 04580262010338 ()
20-27-0480

  • Multiple electrolyte IVD, calibrator
No Description
TOKYO BOEKI MEDISYS INC.
20-27-0478
In Commercial Distribution

  • 04580262010314 ()
20-27-0478

  • Multiple electrolyte IVD, calibrator
No Description
TOKYO BOEKI MEDISYS INC.
20-27-0477
In Commercial Distribution

  • 04580262010307 ()
20-27-0477

  • Multiple electrolyte IVD, calibrator
LiquiCV STAT - Blood Gas / Electrolyte / Metabolite Linearity Control for Abbott iSTAT
PHOENIX DIAGNOSTICS, INC.
PD500S
In Commercial Distribution

  • 00852676007216 ()
  • 10852676007213 ()

  • Total Volume: 2 Milliliter
PD500S

  • Multiple blood gas analyte IVD, control
LiquiCV BGM - Blood Gas / Electrolyte / Metabolite Linearity Control
PHOENIX DIAGNOSTICS, INC.
PD500A
In Commercial Distribution

  • 00852676007209 ()
  • 10852676007206 ()

  • Total Volume: 2 Milliliter
PD500A

  • Multiple blood gas analyte IVD, control
LiquiCV BGP - Blood Gas / Electrolyte / Metabolite Linearity Control (Protein)
PHOENIX DIAGNOSTICS, INC.
PH5001
In Commercial Distribution

  • 00852676007193 ()
  • 10852676007190 ()

  • Total Volume: 2 Milliliter
PH5001

  • Multiple blood gas analyte IVD, control
LiquiTrol BGM - Blood Gas / Electrolyte / Metabolite Control - Trilevel
PHOENIX DIAGNOSTICS, INC.
1009AM
In Commercial Distribution

  • 00852676007148 ()
  • 10852676007145 ()

  • Total Volume: 2 Milliliter
1009AM

  • Multiple blood gas analyte IVD, control
LiquiTrol BGM - Blood Gas / Electrolyte / Metabolite Control - L3
PHOENIX DIAGNOSTICS, INC.
1008AM
In Commercial Distribution

  • 00852676007131 ()
  • 10852676007138 ()

  • Total Volume: 2 Milliliter
1008AM

  • Multiple blood gas analyte IVD, control
LiquiTrol BGM - Blood Gas / Electrolyte / Metabolite Control - L2
PHOENIX DIAGNOSTICS, INC.
1007AM
In Commercial Distribution

  • 00852676007124 ()
  • 10852676007121 ()

  • Total Volume: 2 Milliliter
1007AM

  • Multiple blood gas analyte IVD, control
LiquiTrol BGM - Blood Gas / Electrolyte / Metabolite Control - L1
PHOENIX DIAGNOSTICS, INC.
1006AM
In Commercial Distribution

  • 10852676007114 ()
  • 00852676007117 ()

  • Total Volume: 2 Milliliter
1006AM

  • Multiple blood gas analyte IVD, control
Flame photometer standard 160 Na 8K
INSTRUMENTATION LABORATORY COMPANY
00009751950
Not in Commercial Distribution

  • 08426950086796 ()
  • 18426950086793 ()
00009751950

  • Multiple electrolyte IVD, calibrator
Flame photometer standard 140 Na 5K 1Li
INSTRUMENTATION LABORATORY COMPANY
00003331350
Not in Commercial Distribution

  • 08426950037095 ()
  • 18426950037092 ()
00003331350

  • Multiple electrolyte IVD, calibrator
Flame photometer standard 120 Na 2K
INSTRUMENTATION LABORATORY COMPANY
00009751850
Not in Commercial Distribution

  • 08426950013372 ()
  • 18426950013379 ()
00009751850

  • Multiple electrolyte IVD, calibrator
Urine Standard, 100 Na 100K
INSTRUMENTATION LABORATORY COMPANY
00003510000
Not in Commercial Distribution

  • 08426950010906 ()
00003510000

  • Multiple electrolyte IVD, calibrator
Flame photometer standard 140 Na 5K
INSTRUMENTATION LABORATORY COMPANY
00009751750
Not in Commercial Distribution

  • 08426950001805 ()
  • 18426950001802 ()
00009751750

  • Multiple electrolyte IVD, calibrator
CATECHOLAMINES LEVEL 3
UTAK LABORATORIES, INC.
20209
In Commercial Distribution

  • B800202095 ()
  • B800202090 ()

  • Total Volume: 2 Milliliter
20209

  • Multiple human hormone IVD, control
CATECHOLAMINES LEVEL 2
UTAK LABORATORIES, INC.
20208
In Commercial Distribution

  • B800202085 ()
  • B800202080 ()

  • Total Volume: 2 Milliliter
20208

  • Multiple human hormone IVD, control
CATECHOLAMINES LEVEL 1
UTAK LABORATORIES, INC.
20207
In Commercial Distribution

  • B800202075 ()
  • B800202070 ()

  • Total Volume: 2 Milliliter
20207

  • Multiple human hormone IVD, control
CPK LIQUID (4 x 120mL R1, 1x 30mL R2)
DREW SCIENTIFIC, INC.
XL-CPK2-40
In Commercial Distribution

  • 00817274021354 ()


  • Total creatine kinase (CK) IVD, calibrator
CPK LIQUID (1x 1L R1, 2x 125mL R2)
DREW SCIENTIFIC, INC.
CPK2-1L
In Commercial Distribution

  • 00817274021347 ()


  • Total creatine kinase (CK) IVD, calibrator
CPK LIQUID (1x 120mL R1, 1x 30mL R2)
DREW SCIENTIFIC, INC.
CPK2-120
In Commercial Distribution

  • 00817274021330 ()


  • Total creatine kinase (CK) IVD, calibrator
CPK LIQUID (1x 120mL R1, 1x 30mL R2)
DREW SCIENTIFIC, INC.
DG-CPK2-120
In Commercial Distribution

  • 00817274021323 ()


  • Total creatine kinase (CK) IVD, calibrator
For use as a consistent test sample of known concentration for monitoring assay conditions for Apolipoprotein AI and B.
KAMIYA BIOMEDICAL COMPANY, LLC
K310C-4M
In Commercial Distribution

  • 00816426021648 ()
K310C-4M

  • Multiple apolipoprotein IVD, control
For use as a consistent test sample of known concentration for monitoring assay conditions for Apolipoprotein AI and B.
KAMIYA BIOMEDICAL COMPANY, LLC
K310C-2M
Not in Commercial Distribution

  • 00816426021631 ()
K310C-2M

  • Multiple apolipoprotein IVD, control
No Description
Roche Diagnostics GmbH
08740062160
In Commercial Distribution

  • 07613336164358 ()
08740062160

  • Multiple human hormone IVD, control
For use in the quantitative determination of Sodium, Potassium, and Chloride in Human Urine.
Diamond Diagnostics Inc.
SM-B03417601D
In Commercial Distribution

  • 00811403019038 ()


  • Multiple electrolyte IVD, calibrator
Provide calibration points for the Na, K, Cl and Li electrodes.
Diamond Diagnostics Inc.
MN-2121D
In Commercial Distribution

  • 00811403018925 ()


  • Multiple blood gas analyte IVD, control
Provide Urine calibration points for the Na+, K+, and CI- electrodes.
Diamond Diagnostics Inc.
TB-20270480D
In Commercial Distribution

  • 00811403018598 ()


  • Multiple electrolyte IVD, calibrator
To provide calibration points for the Na+, K+, and CI- electrodes on the Tokyo Boeki Biolis 24i and Prestige 24i Systems.
Diamond Diagnostics Inc.
TB-20270478D
In Commercial Distribution

  • 00811403018574 ()


  • Multiple electrolyte IVD, calibrator
To provide calibration points for the Na+, K+, and CI- electrodes on the Tokyo Boeki Biolis 24i and Prestige 24i Systems.
Diamond Diagnostics Inc.
TB-20270477D
In Commercial Distribution

  • 00811403018567 ()


  • Multiple electrolyte IVD, calibrator
No Description
Diamond Diagnostics Inc.
TB-30270905D
In Commercial Distribution

  • 00811403018529 ()


  • Multiple electrolyte IVD, calibrator
No Description
Diamond Diagnostics Inc.
OY-AUH1018D
In Commercial Distribution

  • 00811403016587 ()


  • Multiple electrolyte IVD, calibrator
For the quantitative determination of Na+, K+, and Cl- concentrations in human serum and urine on Olympus Analyzers.
Diamond Diagnostics Inc.
OY-AUH1014D
In Commercial Distribution

  • 00811403016532 ()


  • Multiple electrolyte IVD, calibrator
For the quantitative determination of Na+, K+, and Cl- concentrations in human serum and urine.
Diamond Diagnostics Inc.
OY-AUH1011D
In Commercial Distribution

  • 00811403016501 ()


  • Multiple electrolyte IVD, calibrator
Provide calibration points for the Na, K, Ca and pH electrodes.
Diamond Diagnostics Inc.
IL-2123D
In Commercial Distribution

  • 00811403015672 ()


  • Multiple blood gas analyte IVD, control
Provide calibration points for the Na+, K+, Cl- and Li+ electrodes.
Diamond Diagnostics Inc.
IL-2121D
In Commercial Distribution

  • 00811403015665 ()


  • Multiple blood gas analyte IVD, control
For monitoring the performance of blood gas, electrolyte, metabolite, and CO-Oximeter (Radiometer) instrumentation for the analytes and analyzers listed on the Expected Values Chart.
Diamond Diagnostics Inc.
DD-97123
In Commercial Distribution

  • 00811403014873 ()


  • Multiple blood gas analyte IVD, control
For monitoring the performance of blood gas, electrolyte, metabolite, and CO-Oximeter (Radiometer) instrumentation for the analytes and analyzers listed on the Expected Values Chart.
Diamond Diagnostics Inc.
DD-97003
In Commercial Distribution

  • 00811403014866 ()


  • Multiple blood gas analyte IVD, control
For monitoring the performance of blood gas, electrolyte, metabolite, and CO-Oximeter (Radiometer) instrumentation for the analytes and analyzers listed on the Expected Values Chart.
Diamond Diagnostics Inc.
DD-97001
In Commercial Distribution

  • 00811403014842 ()


  • Multiple blood gas analyte IVD, control
For monitoring the performance of blood gas, electrolyte, metabolite, and CO-Oximeter.
Diamond Diagnostics Inc.
DD-96123
In Commercial Distribution

  • 00811403014835 ()


  • Multiple blood gas analyte IVD, control
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