DIAGAST

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

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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

Premarket Exempt

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Anti-A (AB01) - 23661562105209 Catalog Number : 210520

Device Description : Blood Grouping Reagent, Anti-A (Murine Monoclonal) (9113D10) - This reagent is d Blood Grouping Reagent, Anti-A (Murine Monoclonal) (9113D10) - This reagent is designed to determine the presence of ABO system blood group antigen A 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 : 5

Anti-B (AB02) - 23661562105216 Catalog Number : 210521

Device Description : Blood Grouping Reagent, Anti-B (Murine Monoclonal) (9621A8) - This reagent is de Blood Grouping Reagent, Anti-B (Murine Monoclonal) (9621A8) - This reagent is designed to determine the presence of ABO system blood group antigen B 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 : 5

Anti-A,B (AB03) - 23661562105223 Catalog Number : 210522

Device Description : Blood Grouping Reagent, Anti-A,B (Murine Monoclonal) (152D12+9113D10) - This rea Blood Grouping Reagent, Anti-A,B (Murine Monoclonal) (152D12+9113D10) - This reagent is designed to determine the presence of ABO system blood group antigen A and B 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 : 5

Anti-D (RH1) IgG - 23661562105247 Catalog Number : 210524

Device Description : Blood Grouping Reagent, Anti-D (Human/Murine Monoclonal) (IgG) (HM16) - This rea Blood Grouping Reagent, Anti-D (Human/Murine Monoclonal) (IgG) (HM16) - This reagent is designed to determine the presence of the blood Rhesus antigen D (RH1) 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 : 5

Anti-D (RH1) IgM - 23661562105254 Catalog Number : 210525

Device Description : Blood Grouping Reagent, Anti-D (Human/Murine Monoclonal) (P3X61) - This reagents Blood Grouping Reagent, Anti-D (Human/Murine Monoclonal) (P3X61) - This reagents are designed to determine the presence of the blood Rhesus antigen D (RH1) 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 : 5

Anti-D (RH1) IgM+IgG - 23661562105261 Catalog Number : 210526

Device Description : Blood Grouping Reagent, Anti-D (Human/Murine Monoclonal Blend) (P3X61+P3X21223B1 Blood Grouping Reagent, Anti-D (Human/Murine Monoclonal Blend) (P3X61+P3X21223B10+P3X290+P3X35) - This reagents are designed to determine the presence of the blood Rhesus antigen D (RH1) on the surface of human red blood cells by manual tube and gel agglutination methods.

Device Class :

Duns Number: 381527001

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 5

Anti-C (RH2) - 23661562105278 Catalog Number : 210527

Device Description : Blood Grouping Reagent, Anti-C (Human/Murine Monoclonal) (P3X25513G8+MS24) - Thi Blood Grouping Reagent, Anti-C (Human/Murine Monoclonal) (P3X25513G8+MS24) - This reagent is designed to determine the presence of the blood group antigen C (Rh2) 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 : 4

Anti-c (RH4) - 23661562105285 Catalog Number : 210528

Device Description : Blood Grouping Reagent, Anti-c (Human/Murine Monoclonal) (951) - This reagent is Blood Grouping Reagent, Anti-c (Human/Murine Monoclonal) (951) - This reagent is designed to determine the presence of the blood group antigen c (Rh4) 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 : 4

Anti-E (RH3) - 23661562105292 Catalog Number : 210529

Device Description : Blood Grouping Reagent, Anti-E (Human/Murine Monoclonal) (906) - This reagent is Blood Grouping Reagent, Anti-E (Human/Murine Monoclonal) (906) - This reagent is designed to determine the presence of the blood group antigen E (Rh3) 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 : 4

Anti-e (RH5) - 23661562105308 Catalog Number : 210230

Device Description : Blood Grouping Reagent, Anti-e (Human/Murine Monoclonal) (P3GD512+MS63) - This r Blood Grouping Reagent, Anti-e (Human/Murine Monoclonal) (P3GD512+MS63) - This reagent is designed to determine the presence of the blood group antigen e (Rh5) 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 : 4

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