FDA.reportPublic FDA data

Na/K/Cl/Ca/Li Solution pack

Primary DI
00386100003128
Brand
Na/K/Cl/Ca/Li Solution pack
Company
MEDICA CORPORATION
Model
2124
Catalog number
2124
Device description
Na/K/Cl/Ca/Li Solution pack for use with EasyLyte analyzers
Published
2018-12-05
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
K152327000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152327000EasyLyte Na/K/Cl/Ca AnalyzerMedica Corporation2016-12-01JFP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00386100003128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00386100003128003861000031283861000031280386100003128

GMDN Terms#

Term, Definition table
TermDefinition
Multiple electrolyte IVD, calibratorA material which is used to establish known points of reference for a number of assays intended to be 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
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08426950807599GEM Premier 5000 PAK BG/ISE/GL/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
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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
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08426950807759GEM Premier 5000 PAK BG/ISE/GL/COOX 300 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
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