EliA IgA Calibrator Strip 83-0003-31

GUDID 07333066013763

EliA IgA Calibrator Strip

Phadia AB

Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 07333066013763
• NIH Device Record Key: b9c0f447-1d6e-4c54-ab33-a0bce1fe1659
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EliA IgA Calibrator Strip
• Version Model Number: 83-0003-31
• Catalog Number: 83-0003-31
• 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: 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07333066012834 [Primary]
GS1	07333066013763 [Package]; Contains: 07333066012834; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062787

FDA Product Code

• MVM: Autoantibodies, endomysial(tissue transglutaminase)

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: 2016-09-23

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