ELDON SCHOOL KIT SKA 2521-25 614-08

GUDID 05713494000504

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 determinat

Eldon Biologicals A/S

ABO/Rh(D) multiple blood grouping IVD, kit, agglutination
Primary Device ID05713494000504
NIH Device Record Keyb921a5e6-b2e4-4915-8791-e3beb63c330e
Commercial Distribution StatusIn Commercial Distribution
Brand NameELDON SCHOOL KIT SKA 2521-25
Version Model Number614-08v03
Catalog Number614-08
Company DUNS307910120
Company NameEldon Biologicals A/S
Device Count50
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
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
Phone+4545931111
Emaileldoncard@eldoncard.com
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
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]
GS105713494000504 [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 Date2018-10-11
Device Publish Date2018-09-10

On-Brand Devices [ELDON SCHOOL KIT SKA 2521-25]

05713494000504For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transf
05713494000405For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transf
05713494000344For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transf
05713494000078For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transf

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