ELDON HOME KIT HKA 2511-1 504-18

GUDID 05713494002409

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.

Eldon Biologicals A/S

ABO/Rh multiple blood grouping IVD, kit, agglutination
Primary Device ID05713494002409
NIH Device Record Key89601b66-162f-4301-9d50-51529feee20b
Commercial Distribution StatusIn Commercial Distribution
Brand NameELDON HOME KIT HKA 2511-1
Version Model Number504-18v13
Catalog Number504-18
Company DUNS307910120
Company NameEldon Biologicals A/S
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105713494002409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSZSystem, Test, Automated Blood Grouping And Antibody

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-06
Device Publish Date2022-11-28

On-Brand Devices [ELDON HOME KIT HKA 2511-1]

05713494000511For self-testing of AB0 and RhD blood groups. Not for use for screening purposes prior to transf
05713494000481For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transf
05713494000467For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transf
05713494000450For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transf
05713494000115For self-testing of AB0 and RhD blood groups. Not for use for screening purposes prior to transf
05713494000054For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transf
05713494000047For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transf
05713494000030For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transf
05713494000528For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transf
05713494000535For self-testing of AB0 and RhD blood groups. Not for use for screening purposes prior to transf
05713494001754For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transf
05713494001990For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transf
05713494002270For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transf
05713494001778For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transf
05713494001761For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transf
05713494002409For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transf
05713494002638For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transf

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