ONE MAN KIT OKA 2511-1 504-37

GUDID 05713494002690

For ABO and RhD Blood grouping. Para ABO y RhD agrupación de la sangre. Not for use for screening purposes prior to transfusion No para uso en cribado antes de transfusion Dry format cards for ABO and /or RhD determination for the grouping of stabilized venous blood, capillary blood or washed resuspended red blood cells. For in vitro diagnostic use by professionals. Manual test for detection/confirmation of the presence or absence of antigens A, B and D on human red blood cells from two individuals per ELDONCARD 2521. For blood centers’, field hospitals preliminary blood group determination prior to conventional blood grouping using capillary blood, venous, or washed suspensions or diluted red blood cells. Not to be used for screening purposes prior to transfusion.

Eldon Biologicals A/S

ABO/Rh multiple blood grouping IVD, kit, agglutination

• Primary Device ID: 05713494002690
• NIH Device Record Key: 43cf0679-5074-48cc-bac3-c0ee1f650d76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONE MAN KIT OKA 2511-1
• Version Model Number: 504-37v01
• Catalog Number: 504-37
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713494002690 [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: 2024-07-15
• Device Publish Date: 2024-07-05

Devices Manufactured by Eldon Biologicals A/S

• 05713494002690 - ONE MAN KIT OKA 2511-1: 2024-07-15For ABO and RhD Blood grouping. Para ABO y RhD agrupación de la sangre. Not for use for screening purposes prior to transfusion No para uso en cribado antes de transfusion Dry format cards for ABO and /or RhD determination for the grouping of stabilized venous blood, capillary blood or washed resuspended red blood cells. For in vitro diagnostic use by professionals. Manual test for detection/confirmation of the presence or absence of antigens A, B and D on human red blood cells from two individuals per ELDONCARD 2521. For blood centers’, field hospitals preliminary blood group determination prior to conventional blood grouping using capillary blood, venous, or washed suspensions or diluted red blood cells. Not to be used for screening purposes prior to transfusion.
• 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