DIAGAST

Address:Parc Eurasante,LOOS Hauts-de-France,FR

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- Catalog Number : 210542

Device Description : Blood Grouping Reagent, Anti-Leb (Murine Monoclonal) (GX336) - This reagent is d Blood Grouping Reagent, Anti-Leb (Murine Monoclonal) (GX336) - This reagent is designed to determine the presence of the blood group antigen Leb (LE2) on the surface of human red blood cells by manual tube method.

Device Class :

Duns Number: 381527001

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

- Catalog Number : 210543

Device Description : Negative control reagent for Anti-D Monoclonal Blood Grouping Reagents (210524-2 Negative control reagent for Anti-D Monoclonal Blood Grouping Reagents (210524-210525-210526) for manual tube technique

Device Class :

Duns Number: 381527001

Premarket Exempt : No

Product Code : KSF

Prescription Use : No

Device Count : 5

- Catalog Number : 210544

Device Description : Low-ionic-strength phosphate buffered saline solution ready for use to prepare h Low-ionic-strength phosphate buffered saline solution ready for use to prepare human red blood cell suspensions for immunohematological testing in tube methods

Device Class : 2

Duns Number: 381527001

Premarket Exempt : Yes

Product Code : KSG

Prescription Use : No

Device Count : 1

- Catalog Number : 210545

Device Description : Papain is a ready to use stabilized solution of proteolytic enzyme, derived from Papain is a ready to use stabilized solution of proteolytic enzyme, derived from papaya (Carica papaya), used to treat human red blood cells in immunohematology.Intended to be used with DIAGAST Anti-Lea (LE1) (REF 210541)

Device Class : 2

Duns Number: 381527001

Premarket Exempt : Yes

Product Code : KSK

Prescription Use : No

Device Count : 1

- Catalog Number : 210546

Device Description : Anti-Human Globulin Anti-IgG,-C3d (Murine Monoclonal) (18833+18896+12011D10) is Anti-Human Globulin Anti-IgG,-C3d (Murine Monoclonal) (18833+18896+12011D10) is intended for use in the direct antiglobulin test to detect the in vivo coating on human red blood cells with IgG and/or C3d components. In addition to recognizing IgG antibodies and the complement fragment C3d, Anti Human Globulin Anti-IgG, C3d is able to recognize IgM antibodies on the surface of red blood cells since IgM antibodies always fix complement

Device Class :

Duns Number: 381527001

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 4

- Catalog Number : 210547

Device Description : Anti-Human Globulin Anti-IgG (Murine Monoclonal) (18833+18896) is intended for u Anti-Human Globulin Anti-IgG (Murine Monoclonal) (18833+18896) is intended for use in the direct antiglobulin test to detect in vivo coating on human red blood cells with IgG and for the indirect antiglobulin test for antibody screening and identification, and crossmatch and for erythrocyte phenotyping with blood phenotyping reagents requiring an indirect antiglobulin test method.

Device Class :

Duns Number: 381527001

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 4

- Catalog Number : 210548

Device Description : Anti-Human Globulin Anti-C3d (Murine Monoclonal) (12011D10) is intended for use Anti-Human Globulin Anti-C3d (Murine Monoclonal) (12011D10) is intended for use in the direct antiglobulin test to detect the in vivo coating of human red blood cells with C3d components. Anti-Human Globulin Anti-C3d only recognizes the complement fragment and, consequently, cannot react with component C4.

Device Class :

Duns Number: 381527001

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 4

- Catalog Number : 210549

Device Description : Anti-Human Globulin Anti-IgG (Murine Monoclonal) (18833+18896) is intended for u Anti-Human Globulin Anti-IgG (Murine Monoclonal) (18833+18896) is intended for use in the direct antiglobulin test to detect in vivo coating on human red blood cells with IgG and for the indirect antiglobulin test for antibody screening and identification, and crossmatch and for erythrocyte phenotyping with blood phenotyping reagents requiring an indirect antiglobulin test method.

Device Class :

Duns Number: 381527001

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 4

- Catalog Number : 210550

Device Description : Anti-Human Globulin Anti-IgG,-C3d (Murine Monoclonal) (18833+18896+12011D10) is Anti-Human Globulin Anti-IgG,-C3d (Murine Monoclonal) (18833+18896+12011D10) is intended for use in the direct antiglobulin test to detect the in vivo coating on human red blood cells with IgG and/or C3d components. In addition to recognizing IgG antibodies and the complement fragment C3d, Anti Human Globulin Anti-IgG, C3d is able to recognize IgM antibodies on the surface of red blood cells since IgM antibodies always fix complement

Device Class :

Duns Number: 381527001

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 4

- Catalog Number : 17301

Device Description : Blood Grouping Reagent Anti-A (Murine Monoclonal) formulated for Automated Syste Blood Grouping Reagent Anti-A (Murine Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® Systems

Device Class :

Duns Number: 381527001

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 10