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)

Premarket Exempt

No Yes

Clear

ALBAcyte C3 Coated Red Blood Cells - 05060242471612 Catalog Number :

Device Description : For control of the indirect and direct antiglobulin test. ALBAcyte® C3 Coated R For control of the indirect and direct antiglobulin test. ALBAcyte® C3 Coated Red Blood Cells is used as a control to confirm the presence or absence of Anti-C3 reactivity of Anti-Human Globulin Reagent and as indicator cells in AHG testing.

Device Class : 2

Duns Number: 516536641

Premarket Exempt : No

Product Code : KSF

Prescription Use : No

Device Count : 1

Anti-Human Globulin Anti-IgG - 05060242471629 Catalog Number :

Device Description : Anti-Human Globulin, Anti-IgG, is intended for use in the direct antiglobulin te Anti-Human Globulin, Anti-IgG, is intended for use in the direct antiglobulin test to detect the in vivo coating of human red blood cells with IgG.Anti-Human Globulin, Anti-IgG, is intended for use in the indirect antiglobulin test to detect the in vitro coating of human red blood cells with IgG.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Anti-Human Globulin Anti-IgG, -C3d Polyspecific Rabbit/Murine Monoclonal (Green) - 05060242471636 Catalog Number :

Device Description : Anti-Human Globulin, Anti-IgG,-C3d; Polyspecific is intended for use in the dire Anti-Human Globulin, Anti-IgG,-C3d; Polyspecific is intended for use in the direct antiglobulin test to detect the in vivo coating of human red blood cells with IgG and/or C3b and/or C3d components.Anti-Human Globulin, Anti-IgG,-C3d; Polyspecific is intended for use in the indirect antiglobulin test to detect the in vitro coating of human red blood cells with IgG and/or C3b and/or C3d components.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAclone® Anti-Cw - 05060242471650 Catalog Number :

Device Description : This Anti-Cw reagent is for the in vitro detection and identification of the hum This Anti-Cw reagent is for the in vitro detection and identification of the human Cw blood group antigen by direct agglutination.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAclone® Anti-C - 05060242471667 Catalog Number :

Device Description : This Anti-C reagent is for the in vitro detection and identification of the huma This Anti-C reagent is for the in vitro detection and identification of the human C blood group antigen by direct agglutination.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAclone® Anti-e - 05060242471674 Catalog Number :

Device Description : This Anti-e reagent is for the in vitro detection and identification of the huma This Anti-e reagent is for the in vitro detection and identification of the human e blood group antigen by direct agglutination.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAclone Anti-K (Monoclonal) - 05060242471681 Catalog Number :

Device Description : The Anti-K reagent is for the in vitro detection and identification of the human The Anti-K reagent is for the in vitro detection and identification of the human K blood group antigen by direct agglutination.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAclone Anti-Fya (Monoclonal IgG) - 05060242471698 Catalog Number :

Device Description : This Anti-Fya reagent is for the in vitro detection and identification of the hu This Anti-Fya reagent is for the in vitro detection and identification of the human Fya blood group antigen by Indirect Antiglobulin Test.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAclone Anti-Jka (Monoclonal) - 05060242471704 Catalog Number :

Device Description : This Anti-Jka reagent is for the in vitro detection and identification of the hu This Anti-Jka reagent is for the in vitro detection and identification of the human Jka blood group antigen by direct agglutination.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAclone Anti-Jkb (Monoclonal) - 05060242471711 Catalog Number :

Device Description : This Anti-Jkb reagent is for the in vitro detection and identification of the hu This Anti-Jkb reagent is for the in vitro detection and identification of the human Jkb blood group antigen by direct agglutination.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

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