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

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl (LBS) (2) Acid, Uric, Uricase (Colorimetric) (KNK) (1) Alkaline Picrate, Colorimetry, Creatinine (CGX) (1) Antistreptolysin - Titer/Streptolysin O Reagent (GTQ) (1) Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes (CGS) (1) Photometric Method, Iron (Non-Heme) (JIY) (1) Photometric Method, Magnesium (JGJ) (1) Acid, Lactic, Enzymatic Method (KHP) (1) Prealbumin, Fitc, Antigen, Antiserum, Control (DDS) (1)

Premarket Exempt

No Yes

Clear

AU - 15099590010706 Catalog Number :

Device Description : Prealbumin

Device Class : 1

Duns Number: 008254708

Premarket Exempt : Yes

Product Code : DDS

Prescription Use : Yes

Device Count : 1

AU - 15099590010737 Catalog Number :

Device Description : Creatinine

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : CGX

Prescription Use : Yes

Device Count : 1

AU - 15099590010744 Catalog Number :

Device Description : CK (NAC)

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : CGS

Prescription Use : Yes

Device Count : 1

AU - 15099590010812 Catalog Number :

Device Description : Iron

Device Class : 1

Duns Number: 008254708

Premarket Exempt : No

Product Code : JIY

Prescription Use : Yes

Device Count : 1

AU - 15099590010850 Catalog Number :

Device Description : Magnesium

Device Class : 1

Duns Number: 008254708

Premarket Exempt : No

Product Code : JGJ

Prescription Use : Yes

Device Count : 1

AU - 15099590010898 Catalog Number :

Device Description : Lactate

Device Class : 1

Duns Number: 008254708

Premarket Exempt : Yes

Product Code : KHP

Prescription Use : Yes

Device Count : 1

AU - 15099590010904 Catalog Number :

Device Description : ASO

Device Class : 1

Duns Number: 008254708

Premarket Exempt : Yes

Product Code : GTQ

Prescription Use : Yes

Device Count : 1

AU - 15099590010911 Catalog Number :

Device Description : HDL-Cholesterol

Device Class : 1

Duns Number: 008254708

Premarket Exempt : No

Product Code : LBS

Prescription Use : Yes

Device Count : 1

AU - 15099590010928 Catalog Number :

Device Description : LDL-Cholesterol

Device Class : 1

Duns Number: 008254708

Premarket Exempt : No

Product Code : LBS

Prescription Use : Yes

Device Count : 1

AU - 15099590010942 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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