BECKMAN COULTER IRELAND INC.

Address:LISMEEHAN,O CALLAGHANS MILLS Clare,IE

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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

Flow Cytometric Reagents And Accessories. (OYE) (3) Counter, Differential Cell (GKZ) (2) Mixture, Hematology Quality Control (JPK) (2) Detergent (JCB) (1) Diluent, Blood Cell (GIF) (1) Products, Red-Cell Lysing Products (GGK) (1)

Premarket Exempt

No Yes

Clear

DxH 500 - 15099590671242 Catalog Number : B40601

Device Description : DxH 500

Device Class : 2

Duns Number: 985071975

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

DxH 500 Series Diluent - 15099590671853 Catalog Number : B36845

Device Description : DxH 500 Series Diluent

Device Class : 1

Duns Number: 985071975

Premarket Exempt : Yes

Product Code : GIF

Prescription Use : Yes

Device Count : 1

DxH 500 Series Lyse - 15099590671860 Catalog Number : B36846

Device Description : DxH 500 Series Lyse

Device Class : 1

Duns Number: 985071975

Premarket Exempt : Yes

Product Code : GGK

Prescription Use : Yes

Device Count : 1

DxH 500 Series Cleaner - 15099590671877 Catalog Number : B36868

Device Description : DxH 500 Series Cleaner

Device Class : 1

Duns Number: 985071975

Premarket Exempt : Yes

Product Code : JCB

Prescription Use : Yes

Device Count : 1

DxH 500 Series Control - 15099590671884 Catalog Number :

Device Description : DxH 500 Series Control

Device Class : 2

Duns Number: 985071975

Premarket Exempt : Yes

Product Code : JPK

Prescription Use : Yes

Device Count : 1

DxH 500 Series Calibrator - 15099590671990 Catalog Number :

Device Description : DxH 520 Series Calibrator

Device Class : 2

Duns Number: 985071975

Premarket Exempt : Yes

Product Code : JPK

Prescription Use : Yes

Device Count : 1

Navios EX - 15099590677466 Catalog Number : B80910

Device Description : Navios EX Flow Cytometer (10 Color/3 Laser)

Device Class : 2

Duns Number: 985071975

Premarket Exempt : No

Product Code : OYE

Prescription Use : Yes

Device Count : 1

DxH 520 - 15099590679781 Catalog Number :

Device Description : DxH 520 Hematology Instrument

Device Class : 2

Duns Number: 985071975

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

Navios EX - 15099590682996 Catalog Number : B80911

Device Description : NAVIOS EX FLOW CYTOMETER (8 COLOR/2 LASER)

Device Class : 2

Duns Number: 985071975

Premarket Exempt : No

Product Code : OYE

Prescription Use : Yes

Device Count : 1

Navios EX - 15099590683009 Catalog Number : B80912

Device Description : NAVIOS EX FLOW CYTOMETER (6 COLOR/2 LASER)

Device Class : 2

Duns Number: 985071975

Premarket Exempt : No

Product Code : OYE

Prescription Use : Yes

Device Count : 1

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