FDA.reportPublic FDA data

Calcium Reference Electrode

Primary DI
00386100003159
Brand
Calcium Reference Electrode
Company
MEDICA CORPORATION
Model
2152
Catalog number
2152
Device description
ISE Disposable Reference Electrode for use with EasyLyte analyzers
Published
2018-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JFPElectrode, Ion Specific, Calcium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFPElectrode, Ion Specific, CalciumClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K943091000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K943091000EASY LYTE CALCIUM ANALYZERMedica Corp.1995-01-17JFP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00386100003159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00386100003159003861000031593861000031590386100003159

GMDN Terms#

Term, Definition table
TermDefinition
Reference electrode IVDAn electrochemical sensor intended to be used as a known reference for electrical potential in an assay that is used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.

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
00811403010028SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics Inc.JFP2023-06-05
00811403015870Daily Rinse KitDiamond Diagnostics Inc.JFP2023-06-05
00811403019892SmartLyte Electrolyte AnalyzerDiamond Diagnostics Inc.JFP2023-06-05
00630414606095epoc NXS HostEpocal IncJFP2020-06-18
10054749005519i-STATABBOTT POINT OF CARE INC.JFP2020-05-01
00386100003630pH/pCO2/pO2/Na/K/Cl AnalyzerMEDICA CORPORATIONJFP2018-12-05
00386100002398Daily Cleaning Solution Kit MEDICA CORPORATIONJFP2018-12-04
00386100002893Calcium Na/K/Ca/pH AnalyzerMEDICA CORPORATIONJFP2018-12-04
00386100003067Na/K/Ca/pH Solution Pack MEDICA CORPORATIONJFP2018-12-04
00386100003111Na/K/Ca/pH Solution PackMEDICA CORPORATIONJFP2018-12-04
00386100003296Daily Rinse/Cleaning Solution Kit MEDICA CORPORATIONJFP2018-12-04
00856522006118CC CartridgeLifehealthJFP2018-04-23
08426950807575GEM Premier 5000 PAK BG/ISE/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807582GEM Premier 5000 PAK BG/ISE/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807599GEM Premier 5000 PAK BG/ISE/GL/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807605GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807612GEM Premier 5000 PAK BG/ISE/COOX 75 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807629GEM Premier 5000 PAK BG/ISE/COOX/TBILI 75 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807636GEM Premier 5000 PAK BG/ISE/GL/COOX 75 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807643GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 75 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807674GEM Premier 5000 PAK BG/ISE/COOX 150 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807681GEM Premier 5000 PAK BG/ISE/COOX/TBILI 150 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807698GEM Premier 5000 PAK BG/ISE/GL/COOX 150 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807704GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 150 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807735GEM Premier 5000 PAK BG/ISE/COOX 300 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807742GEM Premier 5000 PAK BG/ISE/COOX/TBILI 300 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807759GEM Premier 5000 PAK BG/ISE/GL/COOX 300 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807766GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 300 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807797GEM Premier 5000 PAK BG/ISE/COOX 450 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807803GEM Premier 5000 PAK BG/ISE/COOX/TBILI 450 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24