BECKMAN COULTER IRELAND INC.

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) (4) Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control (LKL) (1) Alpha-1-Antitrypsin, Antigen, Antiserum, Control (DEM) (1) Assay, Glycosylated Hemoglobin (LCP) (1) Calibrator, Multi-Analyte Mixture (JIX) (1) Calibrator, Secondary (JIT) (1) Detergent (JCB) (1) Hemoglobin A1c Test System (PDJ) (1) Albumin, Antigen, Antiserum, Control (DCF) (1) Mixture, Hematology Quality Control (JPK) (1)

Premarket Exempt

No Yes

Clear

AU - 15099590010591 Catalog Number :

Device Description : α-1 Acidglycoprotein

Device Class : 1

Duns Number: 985071975

Premarket Exempt : Yes

Product Code : LKL

Prescription Use : Yes

Device Count : 1

AU - 15099590010607 Catalog Number :

Device Description : α-1 ANTITRYPSIN

Device Class : 2

Duns Number: 985071975

Premarket Exempt : No

Product Code : DEM

Prescription Use : Yes

Device Count : 1

AU - 15099590010645 Catalog Number :

Device Description : MICROALBUMIN

Device Class : 2

Duns Number: 985071975

Premarket Exempt : No

Product Code : DCF

Prescription Use : Yes

Device Count : 1

AU - 15099590012120 Catalog Number :

Device Description : HbA1c Advanced

Device Class : 2

Duns Number: 985071975

Premarket Exempt : No

Product Code : PDJ, LCP

Prescription Use : No

Device Count : 1

AU - 15099590070441 Catalog Number :

Device Description : BICARBONATE CALIBRATOR

Device Class : 2

Duns Number: 985071975

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

AU - 15099590131180 Catalog Number :

Device Description : SYSTEM CALIBRATOR

Device Class : 2

Duns Number: 985071975

Premarket Exempt : No

Product Code : JIX

Prescription Use : Yes

Device Count : 1

AQUIOS Tetra-1 Panel - 15099590225704 Catalog Number : B23533

Device Description : AQUIOS Tetra-1 Panel CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5

Device Class : 2

Duns Number: 985071975

Premarket Exempt : No

Product Code : OYE

Prescription Use : Yes

Device Count : 1

AQUIOS Tetra-2+ Panel - 15099590225735 Catalog Number : B23534

Device Description : AQUIOS Tetra-2+ Panel CD45-FITC/(CD56 + CD16)-RD1/CD19-ECD/CD3-PC5

Device Class : 2

Duns Number: 985071975

Premarket Exempt : No

Product Code : OYE

Prescription Use : Yes

Device Count : 1

AQUIOS IMMUNO-TROL Cells - 15099590225759 Catalog Number : B23535

Device Description : AQUIOS Immuno-Trol Cells

Device Class : 2

Duns Number: 985071975

Premarket Exempt : No

Product Code : OYE, JPK

Prescription Use : Yes

Device Count : 1

AQUIOS - 15099590225773 Catalog Number : B23536

Device Description : AQUIOS Sodium Hypochlorite Solution

Device Class : 1

Duns Number: 985071975

Premarket Exempt : No

Product Code : JCB, OYE

Prescription Use : Yes

Device Count : 1

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