MEDICA CORPORATION

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Calibrator, Secondary (JIT) (5) Electrode, Ion Specific, Potassium (CEM) (2) Electrode, Ion Specific, Sodium (JGS) (2) Calibrator, Multi-Analyte Mixture (JIX) (1) Electrode, Ion-Specific, Chloride (CGZ) (1) Flame Photometry, Lithium (JIH) (1)

Premarket Exempt

No Yes

Clear

ISE Sodium electrode - 00386100001636 Catalog Number : 5201

Device Description : ISE Sodium Electrode for use with EasyElectrolyte Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : JGS

Prescription Use : Yes

Device Count : 1

ISE Potassium Electrode - 00386100001643 Catalog Number : 5202

Device Description : ISE Potassium Electrode for use with EasyElectrolyte Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : CEM

Prescription Use : Yes

Device Count : 1

ISE Disposable Reference Electrode - 00386100001650 Catalog Number : 5204

Device Description : ISE Disposable Reference Electrode for use with EasyElectrolyte Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : JGS, CEM, CGZ

Prescription Use : Yes

Device Count : 1

ISE Lithium Electrode - 00386100001667 Catalog Number : 5205

Device Description : ISE Lithium Electrode for use with EasyElectrolyte Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : JIH

Prescription Use : Yes

Device Count : 1

Urine Creatinine Calibrator Kit - 00386100001735 Catalog Number : 10652

Device Description : Urine Creatinine Calibrator Kit for use with EasyRA Analyzer

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

Chemistry HDL Calibrator Kit - 00386100001742 Catalog Number : 10653

Device Description : HDL Calibrator Kit for use with EasyRA Analyzer

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

Chemistry LDL Calibrator - 00386100001766 Catalog Number : 10655

Device Description : LDL Calibrator for use with EasyRA Analyzer

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : JIX

Prescription Use : Yes

Device Count : 1

Chemistry UALB Calibrator Kit - 00386100001773 Catalog Number : 10656

Device Description : Microalbumin Calibrator Kit for use with EasyRA Analyzer

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

Chemistry HbA1c Calibrator Kit - 00386100001797 Catalog Number : 10658

Device Description : HbA1c Calibrator Kit for use with EasyRA Analyzer

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

CRP Calibrator Kit - 00386100001803 Catalog Number : 10659

Device Description : CRP Calibrator Kit for use with EasyRA Analyzer

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

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