ALBA BIOSCIENCE LIMITED

Address:5 JAMES HAMILTON WAY,PENICUIK Midlothian,GB

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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

Kit, Quality Control For Blood Banking Reagents (KSF) (1) Lectins And Protectins (KSI) (1)

Premarket Exempt

No Yes

Clear

ALBAsera Anti-Wra - 05060242471056 Catalog Number :

Device Description : Blood Grouping Reagent, ALBAsera Anti-Wra (Polyclonal) for indirect antiglobulin Blood Grouping Reagent, ALBAsera Anti-Wra (Polyclonal) for indirect antiglobulin test by tube technique.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAlect Anti-A1 Dolichos biflorus Blood Grouping Lectin - 05060242471063 Catalog Number :

Device Description : For the in vitro detection and identification of human A1 red blood cellls

Device Class : 2

Duns Number: 516536641

Premarket Exempt : Yes

Product Code : KSI

Prescription Use : No

Device Count : 1

ALBAcyte A1 Cells - 05060242471124 Catalog Number :

Device Description : 2-3% Reagent Red Blood Cells for ABO Reverse Grouping, ALBAcyte A1 Cells, for tu 2-3% Reagent Red Blood Cells for ABO Reverse Grouping, ALBAcyte A1 Cells, for tube technique.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAcyte A2 Cells - 05060242471131 Catalog Number :

Device Description : 2-3% Reagent Red Blood Cells for ABO Reverse Grouping, ALBAcyte A2 Cells, for tu 2-3% Reagent Red Blood Cells for ABO Reverse Grouping, ALBAcyte A2 Cells, for tube techniques.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAcyte B Cells - 05060242471148 Catalog Number :

Device Description : 2-3% Reagent Red Blood Cells for ABO Reverse Grouping, ALBAcyte B Cells, for tub 2-3% Reagent Red Blood Cells for ABO Reverse Grouping, ALBAcyte B Cells, for tube techniques.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAcyte Orr cells - 05060242471155 Catalog Number :

Device Description : 2-3% Reagent Red Blood Cells for ABO Reverse Grouping, ALBAcyte Orr Cells, for t 2-3% Reagent Red Blood Cells for ABO Reverse Grouping, ALBAcyte Orr Cells, for tube techniques.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAcyte IgG Sensitized Red Blood Cells - 05060242471162 Catalog Number :

Device Description : ALBAcyte IgG Sensitized Red Blood Cells for control of the direct and indirect a ALBAcyte IgG Sensitized Red Blood Cells for control of the direct and indirect antiglobulin test.

Device Class : 2

Duns Number: 516536641

Premarket Exempt : No

Product Code : KSF

Prescription Use : No

Device Count : 1

ALBAcyte Reagent RBCs for Reverse Grouping, Antibody Screen (untreated) - 05060242471179 Catalog Number :

Device Description : 2-3% Reagent Red Blood Cells, ALBAcyte Antibody Screening Cells for tube techniques.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAcyte Reagent RBCs for Antibody Identification Panels (untreated) - 05060242471186 Catalog Number :

Device Description : Reagent Red Blood Cells, ALBAcyte Antibody Identification Cells for tube techniq Reagent Red Blood Cells, ALBAcyte Antibody Identification Cells for tube techniques, 2-3% suspension.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAcyte 2-3% Reagent RBCs for Antibody Identification Panels (papain-treated) - 05060242471193 Catalog Number :

Device Description : Reagent Red Blood Cells, ALBAcyte Antibody Identification Cells (papain-treated) Reagent Red Blood Cells, ALBAcyte Antibody Identification Cells (papain-treated) for tube techniques, 2-3% suspension.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

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