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 ID: 05713494002409
• NIH Device Record Key: 89601b66-162f-4301-9d50-51529feee20b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELDON HOME KIT HKA 2511-1
• Version Model Number: 504-18v13
• Catalog Number: 504-18
• Company DUNS: 307910120
• Company Name: Eldon Biologicals A/S
• Device Count: 1
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713494002409 [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: 2022-12-06
• Device Publish Date: 2022-11-28

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

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