Eldon Biologicals A/S

Address:SANDTOFTEN 10,GENTOFTE Hovedstaden,DK

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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) (10)

Premarket Exempt

Clear

ELDONBOX 2511-100 100 ELDONCARD 2511 - 05713494000016 Catalog Number : 404-02

Device Description : For ABO and Rh D blood grouping Para ABO y Rh D agrupación de la sangre.Not for For ABO and Rh D blood grouping Para ABO y Rh D agrupación de la sangre.Not for use for screening purposes prior to transfusion.No para el uso para defender propósitos antes de la transfusión.Dry format cards for ABO and/or RhD determination for the grouping of stabilized venous blood, capillary blood or washed red cells.

Device Class :

Duns Number: 307910120

Premarket Exempt : No

Product Code : KSZ

Prescription Use : No

Device Count : 100

ELDONBOX 2521-100 100 ELDONCARD 2521 - 05713494000023 Catalog Number : 414-03

Device Description : For ABO and Rh D blood grouping Para ABO y Rh D agrupación de la sangre. Not for For ABO and Rh D blood grouping Para ABO y Rh D agrupación de la sangre. Not for use for screening purposes prior totransfusion. No para el uso para defender propósitos antes de la transfusión. Dry format cards for ABO and/or RhD determinationfor the grouping of stabilized venous blood, capillary blood or washed red cells.

Device Class :

Duns Number: 307910120

Premarket Exempt : No

Product Code : KSZ

Prescription Use : No

Device Count : 200

ELDON HOME KIT HKA 2511-1 - 05713494000030 Catalog Number : 500-07

Device Description : For self-testing of ABO and RhD Blood groups. Not for use for screening purposes For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transfusion. Dry format cards for ABO and/or RhD determination for the grouping of stabilized venous blood, capillary blood or washed red cells.

Device Class : 2

Duns Number: 307910120

Premarket Exempt : No

Product Code : KSZ

Prescription Use : No

Device Count : 1

ELDON HOME KIT HKA 2511-1 - 05713494000047 Catalog Number : 504-16

Device Description : For self-testing of ABO and RhD Blood groups. Not for use for screening purposes For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transfusion. Dry format cards for ABOand/or RhD determination for the grouping of stabilized venous blood, capillary blood or washed red cells.

Device Class : 2

Duns Number: 307910120

Premarket Exempt : No

Product Code : KSZ

Prescription Use : No

Device Count : 1

ELDON HOME KIT HKA 2511-1 - 05713494000054 Catalog Number : 504-18

Device Description : For self-testing of ABO and RhD Blood groups. Not for use for screening purposes For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transfusion. Dry format cards for ABOand/or RhD determination for the grouping of stabilized venous blood, capillary blood or washed red cells.

Device Class : 2

Duns Number: 307910120

Premarket Exempt : No

Product Code : KSZ

Prescription Use : No

Device Count : 1

ELDON SCHOOL KIT SKA 2521-25 - 05713494000078 Catalog Number : 614-07

Device Description : For self-testing of ABO and RhD Blood groups. Not for use for screening purposes For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transfusion. Dry format cards for ABOand/or RhD determination for the grouping of stabilized venous blood, capillary blood or washed red cells.

Device Class :

Duns Number: 307910120

Premarket Exempt : No

Product Code : KSZ

Prescription Use : No

Device Count : 50

DOCTOR´S KIT DKS RhD-25 - 05713494000085 Catalog Number : 660-01

Device Description : For 75 RhD blood group determinations. Dry format cards for ABO and/or RhD deter For 75 RhD blood group determinations. Dry format cards for ABO and/or RhD determination for the grouping of stabilized venous blood, capillary blood or washed red cells.

Device Class :

Duns Number: 307910120

Premarket Exempt : No

Product Code : KSZ

Prescription Use : No

Device Count : 75

ELDON BAG 2511-25 25 ELDONCARD 2511 AB0-D - 05713494000092 Catalog Number : 704-03

Device Description : For AB0 and Rh D Blood Grouping.Para AB0 y Rh D agrupación de la sangre.Not for For AB0 and Rh D Blood Grouping.Para AB0 y Rh D agrupación de la sangre.Not for use for screening purposes prior to transfusion.No para el uso para defender propósitos antes de la transfusión.Dry format cards for ABO and/or RhD determination for the grouping of stabilized venous blood, capillary blood or washed red cells.

Device Class :

Duns Number: 307910120

Premarket Exempt : No

Product Code : KSZ

Prescription Use : No

Device Count : 25

ELDON BAG 2521-25 25 ELDONCARD 2521 AB0-D - 05713494000108 Catalog Number : 714-02

Device Description : For AB0 and Rh D Blood Grouping. Para AB0 y Rh D agrupación de la sangre. Not fo For AB0 and Rh D Blood Grouping. Para AB0 y Rh D agrupación de la sangre. Not for use for screening purposes prior totransfusion. No para el uso para defender propósitos antes de la transfusión. Dry format cards for ABO and/or RhD determinationfor the grouping of stabilized venous blood, capillary blood or washed red cells.

Device Class :

Duns Number: 307910120

Premarket Exempt : No

Product Code : KSZ

Prescription Use : No

Device Count : 50

ELDON HOME KIT HKA 2511-1 - 05713494000115 Catalog Number : 504-15

Device Description : For self-testing of AB0 and RhD blood groups. Not for use for screening purposes For self-testing of AB0 and RhD blood groups. Not for use for screening purposes prior to transfusion. Dry format cards for ABO and/or RhD determination for the grouping of stabilized venous blood, capillary blood or washed red cells.

Device Class : 2

Duns Number: 307910120

Premarket Exempt : No

Product Code : KSZ

Prescription Use : No

Device Count : 1

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