DIAGNOSTIC GRIFOLS SA

Address:PASSEIG FLUVIAL, 24,PARETS DEL VALLES Barcelona,ES

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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

System, Test, Automated Blood Grouping And Antibody (KSZ) (3) Detergent (JCB) (2)

Premarket Exempt

No Yes

Clear

DG Gel 8 Rh Pheno - 08437014205237 Catalog Number : 210387

Device Description : The DG Gel 8 Rh Pheno card is for the determination of human C, E, c, and e anti The DG Gel 8 Rh Pheno card is for the determination of human C, E, c, and e antigens on the surface of red blood cells of two separate blood samples.For use with the DG Gel System.For in vitro diagnostic use.

Device Class :

Duns Number: 463625602

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Grifols Diluent - 08437014205244 Catalog Number : 213677

Device Description : Grifols Diluent is for use in preparing human red blood cell suspensions used wi Grifols Diluent is for use in preparing human red blood cell suspensions used with the DG Gel 8 cards.

Device Class :

Duns Number: 463625602

Premarket Exempt : No

Product Code : KSZ

Prescription Use : Yes

Device Count : 1

Erytra Eflexis - 08437014205305 Catalog Number : 210600

Device Description : Erytra Eflexis® is a fully-automated analyzer designed to automate in vitro immu Erytra Eflexis® is a fully-automated analyzer designed to automate in vitro immunohematological testing of human blood utilizing DG Gel 8 cards technology, including Blood Grouping, Antigen Typing, Antibody Screening, Antibody Identification, Compatibility Tests, and Direct Antiglobulin Tests.As a standalone analyzer or interfaced to the customer’s Laboratory Information System (LIS), Erytra Eflexis® automates test processing functions and data management requirements using DG Gel 8 cards and digital image processing.

Device Class : 2

Duns Number: 463625602

Premarket Exempt : No

Product Code : KSZ

Prescription Use : Yes

Device Count : 1

DG Reader Net - 08437014205619 Catalog Number : 210700

Device Description : DG Reader Net is a device designed to read, interpret, and report the results of DG Reader Net is a device designed to read, interpret, and report the results of the processed DG Gel 8 cards. The instrument also identifies DG Gel 8 cards by reading their barcodes. As a stand-alone or interfaced to the customer’s Laboratory Information System (LIS), the instrument automates data management requirements using DG Gel 8 cards and digital image processing.

Device Class : 2

Duns Number: 463625602

Premarket Exempt : No

Product Code : KSZ

Prescription Use : Yes

Device Count : 1

Grifols Wash Solution A - 08437014205886 Catalog Number : 213682

Device Description : Grifols Wash Solution A is used for internal washing of the Grifols analyzer's f Grifols Wash Solution A is used for internal washing of the Grifols analyzer's fluidic system.The solution must be diluted prior to use.

Device Class : 1

Duns Number: 463625602

Premarket Exempt : Yes

Product Code : JCB

Prescription Use : Yes

Device Count : 1

Grifols Wash Solution B - 08437014205893 Catalog Number : 213683

Device Description : Grifols Wash Solution B is used for internal washing of the Grifols analyzer's f Grifols Wash Solution B is used for internal washing of the Grifols analyzer's fluidic system.The solution must be diluted prior to use.

Device Class : 1

Duns Number: 463625602

Premarket Exempt : Yes

Product Code : JCB

Prescription Use : Yes

Device Count : 1

DG Gel 8 Direct Coombs - 08437014205909 Catalog Number :

Device Description : The DG Gel 8 Direct Coombs card is used for the evaluation of the Direct Antiglo The DG Gel 8 Direct Coombs card is used for the evaluation of the Direct Antiglobulin Test of two different human blood samples. It allows to differentiate red blood cells sensitized in vivo by IgG type immunoglobulins or the complement C3d fractions.For use with the DG Gel System.For in vitro diagnostic use.

Device Class :

Duns Number: 463625602

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

DG Gel 8 ABO/Rh (2D) - 08437014205916 Catalog Number : 210128

Device Description : The DG Gel 8 ABO/Rh (2D) card is for the determination of ABO forward and revers The DG Gel 8 ABO/Rh (2D) card is for the determination of ABO forward and reverse group, and RhD antigen on the surface of red blood cells of human blood samples.For use with the DG Gel System.

Device Class :

Duns Number: 463625602

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

DG Gel 8 ABO/Rh+Kell - 08437014205923 Catalog Number : 210383

Device Description : The DG Gel 8 ABO/Rh + Kell card is for the determination of ABO forward and reve The DG Gel 8 ABO/Rh + Kell card is for the determination of ABO forward and reverse group, and D and K antigens on the surface of red blood cells of human blood samples.For use with the DG Gel System.For in vitro diagnostic use.

Device Class :

Duns Number: 463625602

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

DG Gel 8 A/B/D - 08437014205930 Catalog Number : 210384

Device Description : The DG Gel 8 A/B/D card is for the determination of human A, B and D antigens on The DG Gel 8 A/B/D card is for the determination of human A, B and D antigens on the surface of red blood cells of two separate blood samples.For use with the DG Gel System.For in vitro diagnostic use.

Device Class :

Duns Number: 463625602

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

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