ELDON BAG 2521-25 25 ELDONCARD 2521 AB0-D 714-02

GUDID 05713494000108

For AB0 and Rh D Blood Grouping. Para AB0 y Rh D agrupación de la sangre. Not for use for screening purposes prior to transfusion. No para el uso para

Eldon Biologicals A/S

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

• Primary Device ID: 05713494000108
• NIH Device Record Key: aeeb6e4d-e532-49c9-ad56-19ead56a9ae8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELDON BAG 2521-25 25 ELDONCARD 2521 AB0-D
• Version Model Number: 714-02v06
• Catalog Number: 714-02
• Company DUNS: 307910120
• Company Name: Eldon Biologicals A/S
• Device Count: 50
• 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

Operating and Storage Conditions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713494000108 [Primary]
GS1	05713494000313 [Unit of Use]

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-07

Devices Manufactured by Eldon Biologicals A/S

• 05713494002690 - ONE MAN KIT OKA 2511-1: 2024-07-15 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 2511-1: 2023-03-16 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 2511-1: 2022-12-06 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 2511-1: 2021-10-19 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 2511-1: 2021-10-19 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 2511-1: 2021-09-24 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 2511-1: 2021-05-05 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 2521: 2021-02-12 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