ELDON SCHOOL KIT SKA 2511-30 504-32

GUDID 05713494000498

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 determinati

Eldon Biologicals A/S

ABO/Rh(D) multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination

• Primary Device ID: 05713494000498
• NIH Device Record Key: 03cd3d2c-be33-4b3a-b120-6f83fd8037ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELDON SCHOOL KIT SKA 2511-30
• Version Model Number: 504-32v04
• Catalog Number: 504-32
• Company DUNS: 307910120
• Company Name: Eldon Biologicals A/S
• Device Count: 30
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4545931111
• Email: eldoncard@eldoncard.com
• Phone: +4545931111
• Email: eldoncard@eldoncard.com
• Phone: +4545931111
• Email: eldoncard@eldoncard.com
• Phone: +4545931111
• Email: eldoncard@eldoncard.com
• Phone: +4545931111
• Email: eldoncard@eldoncard.com
• Phone: +4545931111
• Email: eldoncard@eldoncard.com
• Phone: +4545931111
• Email: eldoncard@eldoncard.com
• Phone: +4545931111
• Email: eldoncard@eldoncard.com
• Phone: +4545931111
• Email: eldoncard@eldoncard.com
• Phone: +4545931111
• Email: eldoncard@eldoncard.com
• Phone: +4545931111
• Email: eldoncard@eldoncard.com
• Phone: +4545931111
• Email: eldoncard@eldoncard.com
• Phone: +4545931111
• Email: eldoncard@eldoncard.com
• Phone: +4545931111
• Email: eldoncard@eldoncard.com
• Phone: +4545931111
• Email: eldoncard@eldoncard.com
• Phone: +4545931111
• Email: eldoncard@eldoncard.com
• Phone: +4545931111
• Email: eldoncard@eldoncard.com
• Phone: +4545931111
• Email: eldoncard@eldoncard.com
• Phone: +4545931111
• Email: eldoncard@eldoncard.com
• Phone: +4545931111
• Email: eldoncard@eldoncard.com
• Phone: +4545931111
• Email: eldoncard@eldoncard.com
• Phone: +4545931111
• Email: eldoncard@eldoncard.com
• Phone: +4545931111
• Email: eldoncard@eldoncard.com
• Phone: +4545931111
• Email: eldoncard@eldoncard.com
• Phone: +4545931111
• Email: eldoncard@eldoncard.com
• Phone: +4545931111
• Email: eldoncard@eldoncard.com
• Phone: +4545931111
• Email: eldoncard@eldoncard.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713494000306 [Unit of Use]
GS1	05713494000498 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K790282

FDA Product Code

• KSZ: System, Test, Automated Blood Grouping And Antibody

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-11
• Device Publish Date: 2018-09-10

On-Brand Devices [ELDON SCHOOL KIT SKA 2511-30]

• 05713494000498: For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transf
• 05713494000382: For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transf
• 05713494000368: For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transf