ELDON HOME KIT HKA 2511-5 504-36

GUDID 05713494000306

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(D) multiple blood grouping IVD, kit, agglutination
Primary Device ID05713494000306
NIH Device Record Keyd6928086-a966-450f-b0d4-3404abff555b
Commercial Distribution StatusIn Commercial Distribution
Brand NameELDON HOME KIT HKA 2511-5
Version Model Number504-36v01
Catalog Number504-36
Company DUNS307910120
Company NameEldon Biologicals A/S
Device Count5
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

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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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 37 Degrees Celsius
Handling 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
GS105713494000306 [Unit of Use]
GS105713494001785 [Primary]
GS105713494001792 [Primary]
GS105713494001808 [Primary]
GS105713494001952 [Primary]
GS105713494001969 [Primary]
GS105713494002287 [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 Date2020-12-21
Device Publish Date2020-12-12

Devices Manufactured by Eldon Biologicals A/S

05713494002690 - ONE MAN KIT OKA 2511-12024-07-15 For ABO and RhD Blood grouping. Para ABO y RhD agrupación de la sangre. Not for use for screening purposes prior to transfusion
05713494002638 - ELDON HOME KIT HKA 2511-12023-03-16 For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transfusion. Dry format cards for ABO
05713494002409 - ELDON HOME KIT HKA 2511-12022-12-06 For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transfusion. Dry format cards for ABO
05713494001761 - ELDON HOME KIT HKA 2511-12021-10-19 For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transfusion. Dry format cards for ABO
05713494001778 - ELDON HOME KIT HKA 2511-12021-10-19 For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transfusion. Dry format cards for ABO
05713494002270 - ELDON HOME KIT HKA 2511-12021-09-24 For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transfusion. Dry format cards for ABO
05713494001990 - ELDON HOME KIT HKA 2511-12021-05-05 For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transfusion. Dry format cards for ABO
05713494000313 - ELDONBOX 2521-100 100 ELDONCARD 25212021-02-12 For ABO and Rh D blood grouping Para ABO y Rh D agrupación de la sangre. Not for use for screening purposes prior to transfusio

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