FDA.reportPublic FDA data

ProLyte Electrolyte Analyzer

Primary DI
00811403019984
Brand
ProLyte Electrolyte Analyzer
Company
Diamond Diagnostics Inc.
Model
0-DD-PROLYTE
Device description
The Prolyte® Electrolyte Analyzer is intended to measure sodium, potassium, chloride and lithium in whole blood, serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases involving electrolyte imbalance.
Published
2023-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JGSElectrode, Ion Specific, Sodium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JGSElectrode, Ion Specific, SodiumClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811403019984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811403019984008114030199848114030199840811403019984

GMDN Terms#

Term, Definition table
TermDefinition
Ion-selective analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the quantitative measurement of electrolytes and/or other ions in a clinical specimen using ion-specific membranes to selectively measure electrical potential against a reference electrode to determine the target ion concentration.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
947514303
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811403010158Photometer LampOY-MU8550D2023-06-13
00811403010240Reference SolutionIL-09756904D2023-06-13
00811403013074Pump Tubing KitCD-105673D2023-06-13
00811403013173C1/C2 Cleaning SolutionCD-473389D2023-06-13
00811403010387Wash PackCD-473497D2023-06-13
00811403013296pH ElectrodeCD-476267D2023-06-13
00811403013302Calcium ElectrodeCD-476268D2023-06-13
00811403013319Potassium ElectrodeCD-476270D2023-06-13
00811403013326Reference ElectrodeCD-476273D2023-06-13
00811403013333Chloride ElectrodeCD-476279D2023-06-13
00811403013371Fill SolutionCD-478533D2023-06-13
00811403013388Na-K-Ca-Cl Fill SolutionCD-478535D2023-06-13
00811403013456Conditoner SolutionCD-478701D2023-06-13
00811403013463Reference SolutionCD-478822D2023-06-13
00811403013609Printer PaperCD-67252D2023-06-13
00811403013630Pump TubingCD-673705D2023-06-13
00811403014040Salt Bridge SolutionDA-D105D2023-06-13
00811403014217Quick IMT Sample DiluentDA-S635D2023-06-13
00811403014224Quick IMT Diluent CheckDA-S640D2023-06-13
00811403015504Maintenance KitHM-XEA328ASD2023-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701700860396SelectraVitalScientific B.V.JGS2025-05-06
07613336227763Sodium electrodeRoche Diagnostics GmbHJGS2025-03-05
03661540304187Sodium ElectrodeELITECHGROUP INC.JGS2023-10-01
00811403012541Sodium ElectrodeDiamond Diagnostics Inc.JGS2023-06-12
00811403015849Solution ValveDiamond Diagnostics Inc.JGS2023-06-06
00811403010165Sodium ElectrodeDiamond Diagnostics Inc.JGS2023-06-05
00811403015795Sodium ElectrodeDiamond Diagnostics Inc.JGS2023-06-05
00385480616218Stat ProfileNOVA BIOMEDICAL CORPORATIONJGS2022-12-07
00054749002597i-STATABBOTT POINT OF CARE INC.JGS2021-10-12
00054749004379i-STATABBOTT POINT OF CARE INC.JGS2021-10-12
00054749004386i-STATABBOTT POINT OF CARE INC.JGS2021-10-12
00054749004393i-STATABBOTT POINT OF CARE INC.JGS2021-10-12
04015630014286Sodium ElectrodeRoche Diagnostics GmbHJGS2021-07-30
04015630028702Roche 9180 Sodium electrodeRoche Diagnostics GmbHJGS2021-07-30
04987762129872Sodium ElectrodeJEOL LTD.JGS2020-09-15
00817302023213Carolina Liquid Chemistries Corp. ISE Internal Standard Solution DT88820CAROLINA LIQUID CHEMISTRIES CORPORATIONJGS2020-05-08
00817302023220Carolina Liquid Chemistries Corp. ISE Reference Solution DT88811CAROLINA LIQUID CHEMISTRIES CORPORATIONJGS2020-05-08
04580262010260Na ElectrodeTOKYO BOEKI MEDISYS INC.JGS2019-09-30
08426951070770GEM Premier ChemSTAT PAK Na+,K+,Ca++,Cl-, Glu, Crea, BUN, tCO2, Hct, Lac,pH,pCO2INSTRUMENTATION LABORATORY COMPANYJGS2019-06-28
08426951070787GEM Premier ChemSTAT PAK Na+,K+,Ca++,Cl-, Glu, Crea, BUN, tCO2, Hct, Lac,pH,pCO2INSTRUMENTATION LABORATORY COMPANYJGS2019-06-28
08426951070794GEM Premier ChemSTAT PAK Na+,K+,Ca++,Cl-, Glu, Crea, BUN, tCO2, Hct, Lac,pH,pCO2INSTRUMENTATION LABORATORY COMPANYJGS2019-06-28
08426951070800GEM Premier ChemSTAT PAK Na+,K+,Ca++,Cl-, Glu, Crea, BUN, tCO2, Hct, Lac,pH,pCO2INSTRUMENTATION LABORATORY COMPANYJGS2019-06-28
08426951070817GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, HctINSTRUMENTATION LABORATORY COMPANYJGS2019-06-28
08426951070824GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, HctINSTRUMENTATION LABORATORY COMPANYJGS2019-06-28
08426951070831GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, HctINSTRUMENTATION LABORATORY COMPANYJGS2019-06-28
08426951070848GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, HctINSTRUMENTATION LABORATORY COMPANYJGS2019-06-28
00850229007324SelectaLyte (Sodium Electrode)AWARENESS TECHNOLOGY, INCORPORATEDJGS2019-06-26
00386100001636ISE Sodium electrode MEDICA CORPORATIONJGS2018-12-11
00386100001650ISE Disposable Reference Electrode MEDICA CORPORATIONJGS2018-12-11
00386100002503Na/K/Cl AnalyzerMEDICA CORPORATIONJGS2018-12-11