EliA ANA 3 Positive Control 250 83-0041-11

GUDID 07333066021355

EliA ANA 3 Positive Control 250

Phadia AB

Plasma protein IVD, control

• Primary Device ID: 07333066021355
• NIH Device Record Key: 517fc855-ef5e-4f50-bf37-c94062c81735
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EliA ANA 3 Positive Control 250
• Version Model Number: 83-0041-11
• Catalog Number: 83-0041-11
• Company DUNS: 354019424
• Company Name: Phadia AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: 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
• 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
• 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
• 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
• 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	07333066021324 [Primary]
GS1	07333066021355 [Package]; Contains: 07333066021324; Package: [6 Units]; In Commercial Distribution

FDA Product Code

• JJY: Multi-analyte controls, all kinds (assayed)

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: 2022-04-15
• Device Publish Date: 2022-04-07

Devices Manufactured by Phadia AB

• 07333066015507 - EliA CCP Well: 2026-02-06 EliA CCP Well
• 07333066023908 - EliA IgG Calibrator Well: 2026-02-06 EliA IgG Calibrator Well
• 07333066023939 - EliA Dummy Well: 2026-02-06 EliA Dummy Well
• 07333066023977 - EliA IgA Calibrator Well: 2026-02-06 EliA IgA Calibrator Well
• 07333066024035 - EliA IgM Calibrator Well: 2026-02-06 EliA IgM Calibrator Well
• 07333066024110 - EliA RF IgM Well: 2026-02-06 EliA RF IgM Well
• 07333066024134 - EliA RF IgA Well: 2026-02-06 EliA RF IgA Well
• 07333066021621 - Phadia 2500+ LAS Connector: 2023-11-28 Phadia 2500+ LAS Connector