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

Albumin, Antigen, Antiserum, Control (DCF) (1) Bromcresol Green Dye-Binding, Albumin (CIX) (1) C-Reactive Protein, Antigen, Antiserum, And Control (DCK) (1) Catalytic Methods, Amylase (JFJ) (1) Ferrozine (Colorimetric) Iron Binding Capacity (JMO) (1) Lipase-Esterase, Enzymatic, Photometric, Lipase (CHI) (1) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (1) Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes (CGS) (1) Phosphomolybdate (Colorimetric), Inorganic Phosphorus (CEO) (1) Photometric Method, Magnesium (JGJ) (1) System, Test, Low Density, Lipoprotein (MRR) (1)

Premarket Exempt

No Yes

Clear

AMY Reagent Kit - 00386100002138 Catalog Number : 10217-4

Device Description : Amylase Reagent Kit for use with EasyRA Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : JFJ

Prescription Use : Yes

Device Count : 1

ALB Reagent Kit - 00386100002145 Catalog Number : 10218-4

Device Description : Albumin Reagent Kit for use with EasyRA Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : CIX

Prescription Use : Yes

Device Count : 1

Mg Reagent Kit - 00386100002169 Catalog Number : 10220-4

Device Description : Magnesium Reagent Kit for use with EasyRA Analyzers

Device Class : 1

Duns Number: 112942404

Premarket Exempt : No

Product Code : JGJ

Prescription Use : Yes

Device Count : 1

Phos Reagent Kit - 00386100002176 Catalog Number : 10221-4

Device Description : Phosphorus (Inorganic) Reagent Kit for use with EasyRA Analyzers

Device Class : 1

Duns Number: 112942404

Premarket Exempt : No

Product Code : CEO

Prescription Use : Yes

Device Count : 1

CK Reagent Kit - 00386100002183 Catalog Number : 10222-4

Device Description : Creatine-Kinase Reagent Kit for use with EasyRA Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : CGS

Prescription Use : Yes

Device Count : 1

Iron (Fe) Reagent Kit - 00386100002190 Catalog Number : 10223-4

Device Description : Iron Reagent Kit for use with EasyRA Analyzers

Device Class : 1

Duns Number: 112942404

Premarket Exempt : No

Product Code : JMO

Prescription Use : Yes

Device Count : 1

LDL CHOL Reagent Kit - 00386100002206 Catalog Number : 10224-4

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

Device Class : 1

Duns Number: 112942404

Premarket Exempt : No

Product Code : JJY, MRR

Prescription Use : Yes

Device Count : 1

UALB Reagent Kit - 00386100002213 Catalog Number : 10225-4

Device Description : Microalbumin Reagent Kit for use with EasyRA Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : DCF

Prescription Use : Yes

Device Count : 1

Lipase Reagent Kit - 00386100002237 Catalog Number : 10227-4

Device Description : Lipase Reagent Kit for use with EasyRA Analyzer

Device Class : 1

Duns Number: 112942404

Premarket Exempt : Yes

Product Code : CHI

Prescription Use : Yes

Device Count : 1

CRP Reagent Kit - 00386100002244 Catalog Number : 10228-4

Device Description : Full Range C-Reactive Protein Reagent Kit for use with EasyRA Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : DCK

Prescription Use : Yes

Device Count : 1

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