ELDONBOX 2521-100 100 ELDONCARD 2521 414-03

GUDID 05713494000313

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.

Eldon Biologicals A/S

ABO/Rh(D) multiple blood grouping IVD, kit, agglutination
Primary Device ID05713494000313
NIH Device Record Keyb602f80f-052d-47fc-8236-7538b51089d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameELDONBOX 2521-100 100 ELDONCARD 2521
Version Model Number414-03v03
Catalog Number414-03
Company DUNS307910120
Company NameEldon Biologicals A/S
Device Count200
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

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
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
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
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
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
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
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
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
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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS105713494000313 [Unit of Use]
GS105713494001976 [Primary]
GS105713494002225 [Primary]
GS105713494002546 [Primary]
GS105713494002683 [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 Date2021-02-12
Device Publish Date2021-02-04

On-Brand Devices [ELDONBOX 2521-100 100 ELDONCARD 2521]

05713494000023For ABO and Rh D blood grouping Para ABO y Rh D agrupación de la sangre. Not for use for screen
05713494000313For ABO and Rh D blood grouping Para ABO y Rh D agrupación de la sangre. Not for use for screen

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