Beckman Coulter, Inc.

Address:7381 EMPIRE DR.,FLORENCE,KY,41042,US

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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

Urease And Glutamic Dehydrogenase, Urea Nitrogen (CDQ) (2) Enzymatic Esterase--Oxidase, Cholesterol (CHH) (1) Enzymatic, Carbon-Dioxide (KHS) (1) Hexokinase, Glucose (CFR) (1) Biuret (Colorimetric), Total Protein (CEK) (1) Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides (CDT) (1) Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase (CFJ) (1) Phosphomolybdate (Colorimetric), Inorganic Phosphorus (CEO) (1) Kinetic Method, Gamma-Glutamyl Transpeptidase (JQB) (1)

Premarket Exempt

No Yes

Clear

AU - 15099590010140 Catalog Number :

Device Description : Cholesterol

Device Class : 1

Duns Number: 008254708

Premarket Exempt : Yes

Product Code : CHH

Prescription Use : Yes

Device Count : 1

AU - 15099590010171 Catalog Number :

Device Description : Gamma-Glutamyltransferase (GGT)

Device Class : 1

Duns Number: 008254708

Premarket Exempt : Yes

Product Code : JQB

Prescription Use : Yes

Device Count : 1

AU - 15099590010195 Catalog Number :

Device Description : Glucose

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : CFR

Prescription Use : Yes

Device Count : 1

AU - 15099590010201 Catalog Number :

Device Description : Inorganic Phosphorus

Device Class : 1

Duns Number: 008254708

Premarket Exempt : No

Product Code : CEO

Prescription Use : Yes

Device Count : 1

AU - 15099590010249 Catalog Number :

Device Description : Lactate Dehydrogenase

Device Class : 2

Duns Number: 008254708

Premarket Exempt : Yes

Product Code : CFJ

Prescription Use : Yes

Device Count : 1

AU - 15099590010270 Catalog Number :

Device Description : Lipase

Device Class : 1

Duns Number: 008254708

Premarket Exempt : No

Product Code : CDT

Prescription Use : Yes

Device Count : 1

AU - 15099590010294 Catalog Number :

Device Description : Total Protein

Device Class : 2

Duns Number: 008254708

Premarket Exempt : Yes

Product Code : CEK

Prescription Use : Yes

Device Count : 1

AU - 15099590010317 Catalog Number :

Device Description : Urea/Urea Nitrogen

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : CDQ

Prescription Use : Yes

Device Count : 1

AU - 15099590010348 Catalog Number :

Device Description : Bicarbonate

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : KHS

Prescription Use : Yes

Device Count : 1

AU - 15099590010386 Catalog Number :

Device Description : Urea Stat/Urea Nitrogen Stat

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : CDQ

Prescription Use : Yes

Device Count : 1

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