EliA IgA Calibrator Well DECC055160

GUDID 07333066010694

EliA IgA Calibrator Well

Phadia AB

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

• Primary Device ID: 07333066010694
• NIH Device Record Key: 318bcba7-a595-484b-b91f-3fffcd5a8ec6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EliA IgA Calibrator Well
• Version Model Number: DECC055160
• Catalog Number: DECC055160
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07333066010694 [Package]; Contains: 07333066014654; Package: [4 Units]; In Commercial Distribution
GS1	07333066014654 [Primary]

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

On-Brand Devices [EliA IgA Calibrator Well]

• 07333066010694: EliA IgA Calibrator Well
• 07333066023977: EliA IgA Calibrator Well