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

Manual Blood Grouping And Antibody Test Systems (PBC) (3) System, Test, Automated Blood Grouping And Antibody (KSZ) (3)

Premarket Exempt

No Yes

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DG Gel 8 Anti-C - 08437014205114 Catalog Number : 210121

Device Description : For the determination of human C antigen on the surface of red blood cells of ei For the determination of human C antigen on the surface of red blood cells of eight 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 Anti-E - 08437014205121 Catalog Number : 210122

Device Description : For the determination of human E antigen on the surface of red blood cells of ei For the determination of human E antigen on the surface of red blood cells of eight 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 Anti-c - 08437014205138 Catalog Number : 210123

Device Description : For the determination of human c antigen on the surface of red blood cells of ei For the determination of human c antigen on the surface of red blood cells of eight 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 Anti-e - 08437014205145 Catalog Number : 210124

Device Description : For the determination of human e antigen on the surface of red blood cells of ei For the determination of human e antigen on the surface of red blood cells of eight 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 Spin - 08437014205152 Catalog Number : 210363

Device Description : DG SPIN Centrifugue is a device specifically designed to centrifuge DG Gel 8 cards.

Device Class : 2

Duns Number: 463625602

Premarket Exempt : No

Product Code : PBC

Prescription Use : Yes

Device Count : 1

DG Therm - 08437014205169 Catalog Number : 213734

Device Description : DG THERM Incubator is a device specifically designed to incubate DG Gel 8 Cards DG THERM Incubator is a device specifically designed to incubate DG Gel 8 Cards and/or test tubes at 37ºC for inmmunohematology applications.

Device Class : 2

Duns Number: 463625602

Premarket Exempt : No

Product Code : PBC

Prescription Use : Yes

Device Count : 1

DG Reader - 08437014205176 Catalog Number : 213779

Device Description : The DG Reader is a device designed to read, interpret, and generate reports of t The DG Reader is a device designed to read, interpret, and generate reports of the results of processed DG Gel 8 cards. The instruments also identifies DG Gel 8 cards by Reading their barcodes. As a stand-alone instrument or interfaced to the customer's Laboratory Information System (LIS), the DG Reader automates data management requirements using DG Gel 8 cards and digital image processing.

Device Class : 2

Duns Number: 463625602

Premarket Exempt : No

Product Code : PBC

Prescription Use : Yes

Device Count : 1

WADiana Compact - 08437014205183 Catalog Number : 213789

Device Description : WADiana Compact is a fully automated analyzer designed to automate in vitro immu WADiana Compact is a fully automated analyzer designed to automate in vitro immunohematological testing of human blood utilizing the DG Gel 8 cards technology. As a standalone or interfaced to the customer's Laboratory Information System (LIS), the WADiana Compact analyzer 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

Erytra - 08437014205190 Catalog Number : 210401

Device Description : The Erytra is a fully-automated high-throughput analyzer designed to automate in The Erytra is a fully-automated high-throughput analyzer designed to automate in vitro immunohematologial test of human blood utilizing DG Gel 8 card technology, including Blood Grouping, Antigen Typing, Antibody Screening, Antibody Identification, Compatability Tests, and Direct Antiglobulin Tests.As a standalone analyzer or interfaced to the customer's Laboratory Information System (LIS), the Erytra 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

Erytra - 08437014205220 Catalog Number : 210400

Device Description : The Erytra® is a fully-automated high-throughput analyzer designed to automate i The Erytra® is a fully-automated high-throughput analyzer designed to automate in vitro immunohematological testing of human blood utilizing DG Gel® 8 card 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), the Erytra® 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

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