Quality Control Kits For Blood Banking Reagents
Alba Bioscience Limited
Alba Bioscience Limited
PMN#
Quality Control Kits For Blood Banking Reagents
Alba Bioscience Limited
Quality Control Kits For Blood Banking Reagents
Alba Bioscience Limited
Quality Control Kits For Blood Banking Reagents
Alba Bioscience Limited
Stabilized Enzyme Solutions
ALBA Bioscience Limited (doing Business As Quotient)
Quality Control Kits For Blood Banking Reagents
ALBA Bioscience Limited (doing Business As Quotient)
Quality Control Kits For Blood Banking Reagents
ALBA Bioscience Limited (doing Business As Quotient)
Stabilized Enzyme Solutions
ALBA Bioscience Limited (doing Business As Quotient)
Quality Control Kits For Blood Banking Reagents
ALBA Bioscience Limited (doing Business As Quotient)
Quality Control Kits For Blood Banking Reagents
ALBA Bioscience Limited (doing Business As Quotient)
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
ALBA Bioscience Limited (doing Business As Quotient)
Kit, Quality Control For Blood Banking Reagents
ALBA Bioscience Limited (doing Business As Quotient)
GUDID#
Ortho™ BioClone™ PLUS Anti-Human Globulin IgG - 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.
2026-04-10
Ortho™ BioClone™ PLUS Anti-Human Globulin Anti-IgG (Rabbit) (Green) - 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.
2026-04-10
Ortho™ BioClone™ PLUS Anti-N - This Anti-N reagent is for the in vitro detection and identification of the human N blood group antigen by direct agglutination.
2026-04-10
Ortho™ Confidence Manual System - The Ortho™ Confidence Manual System is intended for daily use to evaluate ABO, RhD and antibody screening reagents by manual blood grouping methods.
2026-03-12
ALBA Elution Kit - The ALBA Elution Kit is intended for use in the acid elution of antibodies from intact red blood cells to allow further detection and/or identification. It is intended for professional use within a blood donor or clinical laboratory environment to perform acid elution of antibodies relating to transfusion in the general population. This pre-analytical procedure is performed manually.The ALBA Elution Kit is an accessory for sample preparation only and does not return diagnostic results for an analyte.The ALBA Elution Kit is Rx only.
2023-10-13
ORTHO® Elution Kit - The Ortho® Elution Kit is intended for use in the acid elution of antibodies from intact red blood cells to allow further detection and/or identification.
2025-12-04
Anti-Human Globulin Anti-IgG, -C3d Polyspecific Rabbit/Murine Monoclonal (Green) - 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.
2018-02-16
ALBAcheck - BGS Monoclonal 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).
2020-06-19
ALBAclone Anti-Jkb (Monoclonal) - This Anti-Jkb reagent is for the in vitro detection and identification of the human Jkb blood group antigen by direct agglutination.
2021-02-01
ALBAsera Anti-Wra - Blood Grouping Reagent, ALBAsera Anti-Wra (Polyclonal) for indirect antiglobulin test by tube technique.
2014-11-14
ALBAclone Anti-A,B - Blood Grouping Reagent, ALBAclone Anti-A,B (Murine Monoclonal IgM) for slide and tube techniques.
2014-11-28
ALBAclone Anti-D alpha - Blood Grouping Reagent, ALBAclone Anti-D alpha (Human/Murine Monoclonal IgM) for slide and tube techniques.
2014-11-14
Anti-human Globulin Anti-IgG, -C3d Polyspecific Rabbit/Murine Monoclonal - 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.
2020-02-20
Anti-Human Globulin Anti-IgG (Rabbit) (Green) - 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.
2020-02-20
ALBAclone Anti-Jka (Monoclonal) - This Anti-Jka reagent is for the in vitro detection and identification of the human Jka blood group antigen by direct agglutination.
2021-02-01
ALBAclone Anti-Jkb (Monoclonal) - This Anti-Jkb reagent is for the in vitro detection and identification of the human Jkb blood group antigen by direct agglutination.
2019-06-21
ALBAclone Anti-Lub - Blood Grouping Reagent, ALBAclone Anti-Lub (Murine Monoclonal IgG) for tube technique.
2014-11-14
ALBAclone Anti-Jka (Monoclonal) - This Anti-Jka reagent is for the in vitro detection and identification of the human Jka blood group antigen by direct agglutination.
2019-06-21
ALBAclone Anti-M - Blood Grouping Reagent, ALBAclone Anti-M (Murine Monoclonal IgG) for tube technique.
2014-11-14
ALBAclone® Anti-Cw - This Anti-Cw reagent is for the in vitro detection and identification of the human Cw blood group antigen by direct agglutination.
2018-06-05
ALBAclone Anti-Fya (Monoclonal IgG) - This Anti-Fya reagent is for the in vitro detection and identification of the human Fya blood group antigen by Indirect Antiglobulin Test.
2019-06-27
Bovine Serum Albumin 22% - Bovine Serum Albumin 22%.
2014-11-14
ALBAclone Anti-P1 (Murine Monoclonal) - This Anti-P1 reagent is for the in vitro detection and identification of human P1 positive red cells by direct agglutination.
2019-06-21
ALBAclone Anti-Lea - Blood Grouping Reagent, ALBAclone Anti-Lea (Murine Monoclonal IgM) for tube technique.
2014-11-14
ALBAclone Anti-Leb - Blood Grouping Reagent, ALBAclone Anti-Leb (Murine Monoclonal IgM) for tube technique.
2014-11-14
ALBAzyme™ Papain Solution Kit - ALBAzyme™ Papain Solution Kit is used for the preparation and testing of papainized red blood cells.
2017-03-29
ALBAclone Anti-E - Blood Grouping Reagent, ALBAclone Anti-E (Human/Murine Monoclonal IgM) for tube technique.
2014-11-28
ALBAclone Anti-K (Monoclonal) - The Anti-K reagent is for the in vitro detection and identification of the human K blood group antigen by direct agglutination.
2019-06-27
ALBAclone® Anti-Human Globulin Anti-C3d - Anti-Human Globulin, Anti-C3d, is intended for use in the direct antiglobulin test to detect the in vivo coating of human red blood cells with C3b and/or C3d components.
2018-02-16
ALBAclone® Anti-C - This Anti-C reagent is for the in vitro detection and identification of the human C blood group antigen by direct agglutination.
2018-06-05
ALBAclone Anti-S (Monoclonal IgG) - The Anti-S reagent is for the in vitro detection and identification of the human S blood group antigen by Indirect Antiglobulin Test.
2019-06-21
ALBAclone Anti-N - Blood Grouping Reagent, ALBAclone Anti-N (Murine Monoclonal IgG) for tube technique.
2014-11-14
ALBAlect Anti-A1 Dolichos biflorus Blood Grouping Lectin - For the in vitro detection and identification of human A1 red blood cellls
2016-09-24
ALBAclone Anti-D fusion - 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.
2018-10-24
ALBAclone Anti-s (Monoclonal IgG) - The Anti-s reagent is for the in vitro detection and identification of the human s blood group antigen by Indirect Antiglobulin Test.
2019-06-27
ALBAhance PEG - ALBAhance PEG for the potentiation of indirect antiglobulin tests.
2014-11-14
ALBAclone Anti-A - Blood Grouping Reagent, ALBAclone Anti-A, Murine Monoclonal IgM for slide and tube techniques.
2014-11-28
ALBAclone Anti-D blend - Blood Grouping Reagent, ALBAclone Anti-D blend (Human/Murine Monoclonal IgM/IgG) for slide and tube techniques.
2014-11-28
ALBAhance LISS Additive Reagent - ALBAhance LISS Additive Reagent.
2014-11-14
Anti-Human Globulin Anti-IgG - 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.
2018-02-16