MEDICA CORPORATION

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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

Diazo Colorimetry, Bilirubin (CIG) (2) Azo Dye, Calcium (CJY) (1) Enzymatic Esterase--Oxidase, Cholesterol (CHH) (1) Enzymatic, Carbon-Dioxide (KHS) (1) Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl (LBS) (1) Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides (CDT) (1) Nadh Oxidation/Nad Reduction, Ast/Sgot (CIT) (1) Acid, Uric, Uricase (Colorimetric) (KNK) (1) Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (CJE) (1)

Premarket Exempt

No Yes

Clear

CHOL Reagent Kit - 00386100002008 Catalog Number : 10204-4

Device Description : Cholesterol Reagent Kit for use with EasyRA Analyzers

Device Class : 1

Duns Number: 112942404

Premarket Exempt : No

Product Code : CHH

Prescription Use : Yes

Device Count : 1

SGOT (AST) Reagent Kit - 00386100002022 Catalog Number : 10206-4

Device Description : Aspartate Aminotransferase Reagent Kit for use with EasyRA Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : CIT

Prescription Use : Yes

Device Count : 1

TBIL Reagent Kit - 00386100002039 Catalog Number : 10207-4

Device Description : Total Bilirubin Reagent Kit for use with EasyRA Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : CIG

Prescription Use : Yes

Device Count : 1

Uric Reagent Kit - 00386100002046 Catalog Number : 10208-4

Device Description : Uric Acid Reagent Kit for use with EasyRA Analyzers

Device Class : 1

Duns Number: 112942404

Premarket Exempt : No

Product Code : KNK

Prescription Use : Yes

Device Count : 1

CO2 Reagent Kit - 00386100002053 Catalog Number : 10209-4

Device Description : Carbon dioxide Reagent Kit for use with EasyRA Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : KHS

Prescription Use : Yes

Device Count : 1

Ca Reagent Kit - 00386100002060 Catalog Number : 10210-4

Device Description : Calcium Reagent Kit for use with EasyRA Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : CJY

Prescription Use : Yes

Device Count : 1

HDL CHOL Reagent Kit - 00386100002077 Catalog Number : 10211-4

Device Description : HDL Cholesterol Reagent Kit for use with EasyRA Analyzers

Device Class : 1

Duns Number: 112942404

Premarket Exempt : No

Product Code : LBS

Prescription Use : Yes

Device Count : 1

DBIL Reagent Kit - 00386100002084 Catalog Number : 10212-4

Device Description : Direct Bilirubin Reagent Kit for use with EasyRA Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : CIG

Prescription Use : Yes

Device Count : 1

ALP Reagent Kit - 00386100002107 Catalog Number : 10214-4

Device Description : Alkaline Phosphatase Reagent Kit for use with EasyRA Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : CJE

Prescription Use : Yes

Device Count : 1

TRIG Reagent Kit - 00386100002121 Catalog Number : 10216-4

Device Description : Triglycerides Reagent Kit for use with EasyRA Analyzers

Device Class : 1

Duns Number: 112942404

Premarket Exempt : No

Product Code : CDT

Prescription Use : Yes

Device Count : 1

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