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) (2)

Premarket Exempt

No Yes

Clear

ALBAclone Anti-S (Monoclonal IgG) - 05060242471742 Catalog Number :

Device Description : The Anti-S reagent is for the in vitro detection and identification of the human The Anti-S reagent is for the in vitro detection and identification of the human S 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-s (Monoclonal IgG) - 05060242471759 Catalog Number :

Device Description : The Anti-s reagent is for the in vitro detection and identification of the human The Anti-s reagent is for the in vitro detection and identification of the human s 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-P1 (Murine Monoclonal) - 05060242471766 Catalog Number :

Device Description : This Anti-P1 reagent is for the in vitro detection and identification of human P This Anti-P1 reagent is for the in vitro detection and identification of human P1 positive red cells by direct agglutination.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAclone® Anti-Fyb (Human/Murine Monoclonal) - 05060242471780 Catalog Number :

Device Description : The Anti-Fyb reagent is for the in vitro detection and identification of human F The Anti-Fyb reagent is for the in vitro detection and identification of human Fyb positive red blood cells by direct agglutination.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

ALBAclone Anti-D fusion - 05060242471797 Catalog Number :

Device Description : This Anti-D reagent is for the in vitro detection and identification of human Rh This Anti-D reagent is for the in vitro detection and identification of human RhD blood group status in patient and donor samples by direct agglutination and the indirect antiglobulin test.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAcyte IgG Sensitized Red Blood Cells II - 05060242472329 Catalog Number :

Device Description : These IgG Sensitized Red Blood Cells are for the control of the Indirect Antiglo These IgG Sensitized Red Blood Cells are for the control of the Indirect Antiglobulin Test (IAT) and Direct Antiglobulin Test (DAT).

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code : KSF

Prescription Use : Yes

Device Count : 1

Anti-human Globulin Anti-IgG, -C3d Polyspecific Rabbit/Murine Monoclonal - 05060242472367 Catalog Number :

Device Description : Anti-Human Globulin Anti-IgG,-C3d; Polyspecific is intended for use in the direc 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

Anti-Human Globulin Anti-IgG (Rabbit) (Green) - 05060242472404 Catalog Number :

Device Description : Anti-Human Globulin Anti-IgG is intended for use in the direct antiglobulin test 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

ALBAcheck - BGS Monoclonal Control - 05060242472473 Catalog Number :

Device Description : ALBAcheck - BGS Monoclonal Control is designed to be used as a negative control ALBAcheck - BGS Monoclonal Control is designed to be used as a negative control in conjunction with Alba Bioscience Limited monoclonal blood grouping reagents (where referenced in the reagent IFU).

Device Class : 2

Duns Number: 516536641

Premarket Exempt : No

Product Code : KSF

Prescription Use : No

Device Count : 1

ALBAclone Anti-Jka (Monoclonal) - 05060242472480 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

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