FDA.reportPublic FDA data

ISE Lithium Electrode

Primary DI
00386100001667
Brand
ISE Lithium Electrode
Company
MEDICA CORPORATION
Model
5205
Catalog number
5205
Device description
ISE Lithium Electrode for use with EasyElectrolyte Analyzers
Published
2018-12-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JIHFlame Photometry, Lithium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIHFlame Photometry, LithiumClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002407000EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZERMedica Corp.2001-02-02JGS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00386100001667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00386100001667003861000016673861000016670386100001667

GMDN Terms#

Term, Definition table
TermDefinition
Lithium electrodeAn electrochemical sensor that preferentially responds as a potentiometric indicator to lithium ions.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
781-275-4892technicalsupport@medicacorp.com

Regulatory Flags#

DUNS number
112942404
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00386100002145ALB Reagent Kit10218-410218-42019-02-14
00386100002008CHOL Reagent Kit 10204-410204-42019-02-14
00386100002022SGOT (AST) Reagent Kit10206-410206-42019-02-14
00386100002039TBIL Reagent Kit10207-410207-42019-02-14
00386100002053CO2 Reagent Kit 10209-410209-42019-02-14
00386100002060Ca Reagent Kit 10210-410210-42019-02-14
00386100002077HDL CHOL Reagent Kit10211-410211-42019-02-14
00386100002084DBIL Reagent Kit 10212-410212-42019-02-14
00386100002107ALP Reagent Kit 10214-410214-42019-02-14
00386100002121TRIG Reagent Kit10216-410216-42019-02-14
00386100002138AMY Reagent Kit10217-410217-42019-02-14
00386100002169Mg Reagent Kit10220-410220-42019-02-14
00386100002176Phos Reagent Kit10221-410221-42019-02-14
00386100002183CK Reagent Kit 10222-410222-42019-02-14
00386100002190Iron (Fe) Reagent Kit10223-410223-42019-02-14
00386100002206LDL CHOL Reagent Kit 10224-410224-42019-02-14
00386100002213UALB Reagent Kit10225-410225-42019-02-14
00386100002237Lipase Reagent Kit 10227-410227-42019-02-20
00386100002244CRP Reagent Kit10228-410228-42019-02-14
00386100002268HbA1c Reagent Kit 10230-210230-22019-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811403015979Internal Filling Solution Diamond Diagnostics Inc.JIH2023-06-06
00811403010028SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics Inc.JIH2023-06-05
00811403019892SmartLyte Electrolyte AnalyzerDiamond Diagnostics Inc.JIH2023-06-05
00811403019984ProLyte Electrolyte AnalyzerDiamond Diagnostics Inc.JIH2023-06-05
00386100002282ISE Reagent PackMEDICA CORPORATIONJIH2019-02-14
00386100004378EasyRA Analyzer (LIS)MEDICA CORPORATIONJIH2019-02-14
00386100004385EasyRA Analyzer (ISE&LIS)MEDICA CORPORATIONJIH2019-02-14
00386100002480Lithium Electrode MEDICA CORPORATIONJIH2018-12-11
00386100002558EasyElectrolyte Reagent Module, Na/K/Li AnalyzersMEDICA CORPORATIONJIH2018-12-11
00386100003524Na/K/Li AnalyzerMEDICA CORPORATIONJIH2018-12-11
00386100002886Lithium Na/K/Li AnalyzerMEDICA CORPORATIONJIH2018-12-04
00386100002909Na/K/Cl/Li AnalyzerMEDICA CORPORATIONJIH2018-12-04
00386100002916Na/K/Cl/Li Solution Pack MEDICA CORPORATIONJIH2018-12-04
00386100002923Na/K/Cl/Li Solution PackMEDICA CORPORATIONJIH2018-12-04
00386100003074Na/K/Li Solution PackMEDICA CORPORATIONJIH2018-12-04
00386100003104Na/K/Li Solution PackMEDICA CORPORATIONJIH2018-12-04
00386100003005Lithium ElectrodeMEDICA CORPORATIONJIH2018-11-08
00842768005367Dimension® Flex® reagent cartridge LISiemens Healthcare Diagnostics Inc.JIH2016-09-24
00630414451824RAPIDChem® 754 Na+K+Li+ Reagent ModuleSiemens Healthcare Diagnostics Inc.JIH2016-09-24
00630414451862RAPIDChem® 700 Lithium SensorSiemens Healthcare Diagnostics Inc.JIH2016-09-24
04015630028795Roche 9180 Lithium ElectrodeRoche Diagnostics GmbHJIH2016-09-20
10758750004720VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JIH2016-08-26
10758750009466VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JIH2016-08-26