ELDON BIOLOGICALS A/S

Matched from indexed company URL: Eldon Biologicals A

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30037831423003783142ELDON BIOLOGICALS A/S1N2026-01-01SANDTOFTEN 10 GENTOFTE Hovedstaden DK DK-2820

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05713494000351DOCTOR'S KIT DKS RhD-25 - For 75 RhD blood group determinations. Not for use for screening purposes prior to transfusion. Dry format cards for RhD determination for the grouping of stabilized venous blood, capillary blood or washed red cells.+4545931111eldoncard@eldoncard.com
05713494002409ELDON HOME KIT HKA 2511-1 - 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.+4545931111eldoncard@eldoncard.com
05713494002638ELDON HOME KIT HKA 2511-1 - 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.+4545931111eldoncard@eldoncard.com
05713494002683ELDON MILITARY KIT MKA 2521-25 - For ABO and RhD Blood grouping.Para ABO y RhD agrupación de la sangre.Not for use for screening purposes prior to transfusion No para uso en cribado antes de transfusionDry format cards for ABO and /or RhD determination for the grouping of stabilized venous blood, capillary blood or washed resuspended red blood cells. For in vitro diagnostic use by professionals. Manual test for detection/confirmation of the presence or absence of antigens A, B and D on human red blood cells from two individuals per ELDONCARD 2521. For blood centers’, field hospitals preliminary blood group determination prior to conventional blood grouping using capillary blood, venous, or washed suspensions or diluted red blood cells. Not to be used for screening purposes prior to transfusion.+4545931111eldoncard@eldoncard.com
05713494002690ONE MAN KIT OKA 2511-1 - For ABO and RhD Blood grouping.Para ABO y RhD agrupación de la sangre.Not for use for screening purposes prior to transfusion No para uso en cribado antes de transfusionDry format cards for ABO and /or RhD determination for the grouping of stabilized venous blood, capillary blood or washed resuspended red blood cells. For in vitro diagnostic use by professionals. Manual test for detection/confirmation of the presence or absence of antigens A, B and D on human red blood cells from two individuals per ELDONCARD 2521. For blood centers’, field hospitals preliminary blood group determination prior to conventional blood grouping using capillary blood, venous, or washed suspensions or diluted red blood cells. Not to be used for screening purposes prior to transfusion.+4545931111eldoncard@eldoncard.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
173491159215654K790282ELDONCARDKSZ1979-05-04

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KSZ11979-05-04

GUDID#

ELDON MILITARY KIT MKA 2521-25 - For ABO and RhD Blood grouping.Para ABO y RhD agrupación de la sangre.Not for use for screening purposes prior to transfusion No para uso en cribado antes de transfusionDry format cards for ABO and /or RhD determination for the grouping of stabilized venous blood, capillary blood or washed resuspended red blood cells. For in vitro diagnostic use by professionals. Manual test for detection/confirmation of the presence or absence of antigens A, B and D on human red blood cells from two individuals per ELDONCARD 2521. For blood centers’, field hospitals preliminary blood group determination prior to conventional blood grouping using capillary blood, venous, or washed suspensions or diluted red blood cells. Not to be used for screening purposes prior to transfusion.

Eldon Biologicals A/S

2024-07-05

ONE MAN KIT OKA 2511-1 - For ABO and RhD Blood grouping.Para ABO y RhD agrupación de la sangre.Not for use for screening purposes prior to transfusion No para uso en cribado antes de transfusionDry format cards for ABO and /or RhD determination for the grouping of stabilized venous blood, capillary blood or washed resuspended red blood cells. For in vitro diagnostic use by professionals. Manual test for detection/confirmation of the presence or absence of antigens A, B and D on human red blood cells from two individuals per ELDONCARD 2521. For blood centers’, field hospitals preliminary blood group determination prior to conventional blood grouping using capillary blood, venous, or washed suspensions or diluted red blood cells. Not to be used for screening purposes prior to transfusion.

Eldon Biologicals A/S

2024-07-05

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