Beckman Coulter, Inc.

Address:2470 Faraday Ave,CARLSBAD,CA,92010,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

Method, Nephelometric, Immunoglobulins (G, A, M) (CFN) (3) Cardiac C-Reactive Protein, Antigen, Antiserum, And Control (NQD) (1) Colorimetric Method, Cpk Or Isoenzymes (JHY) (1) Diazo Colorimetry, Bilirubin (CIG) (1) Ferritin, Antigen, Antiserum, Control (DBF) (1) Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides (CDT) (1) Azo Dye, Calcium (CJY) (1) System, Test, Rheumatoid Factor (DHR) (1)

Premarket Exempt

No Yes

Clear

AU - 15099590010959 Catalog Number :

Device Description : CRP Latex

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : NQD

Prescription Use : Yes

Device Count : 1

AU - 15099590010966 Catalog Number :

Device Description : RF Latex

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : DHR

Prescription Use : Yes

Device Count : 1

AU - 15099590011086 Catalog Number :

Device Description : Calcium Arsenazo

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : CJY

Prescription Use : Yes

Device Count : 1

AU - 15099590011093 Catalog Number :

Device Description : Triglyceride

Device Class : 1

Duns Number: 008254708

Premarket Exempt : No

Product Code : CDT

Prescription Use : Yes

Device Count : 1

AU - 15099590011468 Catalog Number :

Device Description : CK-MB

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : JHY

Prescription Use : Yes

Device Count : 1

AU - 15099590011574 Catalog Number :

Device Description : IgA

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : CFN

Prescription Use : Yes

Device Count : 1

AU - 15099590011581 Catalog Number :

Device Description : IgG

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : CFN

Prescription Use : Yes

Device Count : 1

AU - 15099590011598 Catalog Number :

Device Description : IgM

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : CFN

Prescription Use : Yes

Device Count : 1

AU - 15099590011680 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 - 15099590011901 Catalog Number :

Device Description : Ferritin

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : DBF

Prescription Use : Yes

Device Count : 1

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