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

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (JJE) (3) Azo Dye, Calcium (CJY) (1) Fibrin Split Products (GHH) (1) General Purpose Reagent (PPM) (1) Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (CJE) (1) Starch-Dye Bound Polymer, Amylase (CIW) (1) Acid, Uric, Uricase (Colorimetric) (KNK) (1) System, Test, Automated Blood Grouping And Antibody (KSZ) (1)

Premarket Exempt

No Yes

Clear

AU - 14987666543009 Catalog Number :

Device Description : AU680 Chemistry Analyzer (with ISE)

Device Class : 1

Duns Number: 008254708

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

AU - 14987666543016 Catalog Number :

Device Description : AU5800 Chemistry Analyzer

Device Class : 1

Duns Number: 008254708

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

AU - 14987666543023 Catalog Number :

Device Description : AU5800 Chemistry Analyzer, Automation-ready

Device Class : 1

Duns Number: 008254708

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

PK7400 - 14987666543344 Catalog Number :

Device Description : PK7400 Automated Microplate System

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : KSZ

Prescription Use : Yes

Device Count : 1

AU - 15099590000028 Catalog Number :

Device Description : ALP

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : CJE

Prescription Use : Yes

Device Count : 1

AU - 15099590000035 Catalog Number :

Device Description : α-Amylase

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : CIW

Prescription Use : Yes

Device Count : 1

AU - 15099590000110 Catalog Number :

Device Description : Wash Solution

Device Class : 1

Duns Number: 008254708

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 1

AU - 15099590000325 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 - 15099590000332 Catalog Number :

Device Description : D-Dimer

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : GHH

Prescription Use : Yes

Device Count : 1

AU - 15099590000349 Catalog Number :

Device Description : Uric Acid

Device Class : 1

Duns Number: 008254708

Premarket Exempt : No

Product Code : KNK

Prescription Use : Yes

Device Count : 1

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