Beckman Coulter, Inc.

Address:250 S Kraemer Blvd,BREA,CA,92821,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

Turbidimetric Method, Lipoproteins (JHN) (2) Ceruloplasmin, Antigen, Antiserum, Control (DDB) (1) Complement C3, Antigen, Antiserum, Control (CZW) (1) Complement C4, Antigen, Antiserum, Control (DBI) (1) Biuret (Colorimetric), Total Protein (CEK) (1) System, Test, Beta-2-Microglobulin Immunological (JZG) (1) System, Test, C-Reactive Protein (DCN) (1) Transferrin, Rhodamine, Antigen, Antiserum, Control (DDD) (1) Haptoglobin, Antigen, Antiserum, Control (DAD) (1)

Premarket Exempt

No Yes

Clear

AU - 15099590010393 Catalog Number :

Device Description : APO A1

Device Class : 1

Duns Number: 008254708

Premarket Exempt : No

Product Code : JHN

Prescription Use : Yes

Device Count : 1

AU - 15099590010409 Catalog Number :

Device Description : APO B

Device Class : 1

Duns Number: 008254708

Premarket Exempt : No

Product Code : JHN

Prescription Use : Yes

Device Count : 1

AU - 15099590010447 Catalog Number :

Device Description : CRP

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : DCN

Prescription Use : Yes

Device Count : 1

AU - 15099590010485 Catalog Number :

Device Description : β-2 Microglobulin

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : JZG

Prescription Use : Yes

Device Count : 1

AU - 15099590010492 Catalog Number :

Device Description : Transferrin

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : DDD

Prescription Use : Yes

Device Count : 1

AU - 15099590010560 Catalog Number :

Device Description : C3

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : CZW

Prescription Use : Yes

Device Count : 1

AU - 15099590010577 Catalog Number :

Device Description : C4

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : DBI

Prescription Use : Yes

Device Count : 1

AU - 15099590010614 Catalog Number : OSR6164

Device Description : Ceruloplasmin Reagent

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : DDB

Prescription Use : Yes

Device Count : 1

AU - 15099590010621 Catalog Number :

Device Description : Haptoglobin

Device Class : 2

Duns Number: 008254708

Premarket Exempt : Yes

Product Code : DAD

Prescription Use : Yes

Device Count : 1

AU - 15099590010676 Catalog Number :

Device Description : Urinary/CSF Protein

Device Class : 2

Duns Number: 008254708

Premarket Exempt : Yes

Product Code : CEK

Prescription Use : Yes

Device Count : 1

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