EliA RF IgM Well DECC067000

GUDID 07333066024110

EliA RF IgM Well

Phadia AB

Rheumatoid factor IVD, kit, fluorescent immunoassay

• Primary Device ID: 07333066024110
• NIH Device Record Key: c6c8852b-6fb0-4f1c-bd65-47c1318bdfca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EliA RF IgM Well
• Version Model Number: DECC067000
• Catalog Number: DECC067000
• Company DUNS: 354019424
• Company Name: Phadia AB
• 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: false
• Device Combination Product: false
• Single Use: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +469999999999
• Email: xx@xx.xx
• Phone: +469999999999
• Email: xx@xx.xx
• Phone: +469999999999
• Email: xx@xx.xx
• Phone: +469999999999
• Email: xx@xx.xx
• Phone: +469999999999
• Email: xx@xx.xx
• Phone: +469999999999
• Email: xx@xx.xx
• Phone: +469999999999
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07333066024110 [Package]; Contains: 07333066024325; Package: [4 Units]; In Commercial Distribution
GS1	07333066024325 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102673

FDA Product Code

• DHR: SYSTEM, TEST, RHEUMATOID FACTOR

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: 2026-02-06
• Device Publish Date: 2026-01-29

On-Brand Devices [EliA RF IgM Well]

• 07333066010854: EliA RF IgM Well
• 07333066024110: EliA RF IgM Well