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 Test System For Hematopoietic Neoplasms (PWD) (5) Calibrator, Multi-Analyte Mixture (JIX) (2) Flow Cytometric Reagents And Accessories. (OYE) (2) Calibrator, Secondary (JIT) (1)

Premarket Exempt

No Yes

Clear

Navios - 15099590515492 Catalog Number : A52102

Device Description : Navios Flow Cytometer

Device Class : 2

Duns Number: 985071975

Premarket Exempt : No

Product Code : OYE

Prescription Use : Yes

Device Count : 1

Navios - 15099590515522 Catalog Number : A52103

Device Description : Navios Flow Cytometer

Device Class : 2

Duns Number: 985071975

Premarket Exempt : No

Product Code : OYE

Prescription Use : Yes

Device Count : 1

AU - 15099590635572 Catalog Number :

Device Description : Lyophilized Chemistry Calibrator Level 2

Device Class : 2

Duns Number: 985071975

Premarket Exempt : No

Product Code : JIX

Prescription Use : Yes

Device Count : 1

AU - 15099590635602 Catalog Number :

Device Description : Lyophilized Chemistry Calibrator Level 1

Device Class : 2

Duns Number: 985071975

Premarket Exempt : No

Product Code : JIX

Prescription Use : Yes

Device Count : 1

AU - 15099590666361 Catalog Number :

Device Description : Urine CSF Albumin Calibrator

Device Class : 2

Duns Number: 985071975

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

ClearLLab - 15099590670979 Catalog Number : B66807

Device Description : ClearLLab T1

Device Class : 2

Duns Number: 985071975

Premarket Exempt : No

Product Code : PWD

Prescription Use : Yes

Device Count : 1

ClearLLab - 15099590670986 Catalog Number : B66808

Device Description : ClearLLab T2

Device Class : 2

Duns Number: 985071975

Premarket Exempt : No

Product Code : PWD

Prescription Use : Yes

Device Count : 1

ClearLLab - 15099590670993 Catalog Number : B66809

Device Description : ClearLLab B1

Device Class : 2

Duns Number: 985071975

Premarket Exempt : No

Product Code : PWD

Prescription Use : Yes

Device Count : 1

ClearLLab - 15099590671006 Catalog Number : B66810

Device Description : ClearLLab B2

Device Class : 2

Duns Number: 985071975

Premarket Exempt : No

Product Code : PWD

Prescription Use : Yes

Device Count : 1

ClearLLab - 15099590671013 Catalog Number : B66812

Device Description : ClearLLab M

Device Class : 2

Duns Number: 985071975

Premarket Exempt : No

Product Code : PWD

Prescription Use : Yes

Device Count : 1

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