Beckman Coulter, Inc.

Address:5350 Lakeview Parkway South Dr,INDIANAPOLIS,IN,46268,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

Diazo Colorimetry, Bilirubin (CIG) (2) Bromcresol Green Dye-Binding, Albumin (CIX) (1) Cresolphthalein Complexone, Calcium (CIC) (1) Enzymatic Esterase--Oxidase, Cholesterol (CHH) (1) Ferrozine (Colorimetric) Iron Binding Capacity (JMO) (1) General Purpose Reagent (PPM) (1) Nadh Oxidation/Nad Reduction, Ast/Sgot (CIT) (1) Assay, Glycosylated Hemoglobin (LCP) (1) Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (CJE) (1)

Premarket Exempt

No Yes

Clear

AU - 15099590011925 Catalog Number :

Device Description : UIBC

Device Class : 1

Duns Number: 008254708

Premarket Exempt : No

Product Code : JMO

Prescription Use : Yes

Device Count : 1

AU - 15099590012052 Catalog Number :

Device Description : HbA1c

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

AU - 15099590012069 Catalog Number :

Device Description : System Monitoring Solution

Device Class : 1

Duns Number: 008254708

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 1

AU - 15099590020002 Catalog Number :

Device Description : Albumin

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : CIX

Prescription Use : Yes

Device Count : 1

AU - 15099590020019 Catalog Number :

Device Description : ALP

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : CJE

Prescription Use : Yes

Device Count : 1

AU - 15099590020026 Catalog Number :

Device Description : AST

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : CIT

Prescription Use : Yes

Device Count : 1

AU - 15099590020033 Catalog Number :

Device Description : Direct Bilirubin

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : CIG

Prescription Use : Yes

Device Count : 1

AU - 15099590020040 Catalog Number :

Device Description : Total Bilirubin

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : CIG

Prescription Use : Yes

Device Count : 1

AU - 15099590020057 Catalog Number :

Device Description : Calcium oCPC

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : CIC

Prescription Use : Yes

Device Count : 1

AU - 15099590020071 Catalog Number :

Device Description : Cholesterol

Device Class : 1

Duns Number: 008254708

Premarket Exempt : Yes

Product Code : CHH

Prescription Use : Yes

Device Count : 1

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