ELDON HOME KIT HKA 2511-5 504-36

GUDID 05713494000306

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

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• Primary Device ID: 05713494000306
• NIH Device Record Key: d6928086-a966-450f-b0d4-3404abff555b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELDON HOME KIT HKA 2511-5
• Version Model Number: 504-36v01
• Catalog Number: 504-36
• Company DUNS: 307910120
• Company Name: Eldon Biologicals A/S
• Device Count: 5
• 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

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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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 37 Degrees Celsius
• Handling 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
• 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	05713494001785 [Primary]
GS1	05713494001792 [Primary]
GS1	05713494001808 [Primary]
GS1	05713494001952 [Primary]
GS1	05713494001969 [Primary]
GS1	05713494002287 [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: 2020-12-21
• Device Publish Date: 2020-12-12

Devices Manufactured by Eldon Biologicals A/S

• 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
• 05713494000306 - ELDON HOME KIT HKA 2511-5: 2020-12-21For 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.
• 05713494000306 - ELDON HOME KIT HKA 2511-5: 2020-12-21 For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transfusion. Dry format cards for ABO