EliA IgM Calibrator Well DECC055270

GUDID 07333066010748

EliA IgM Calibrator Well

Phadia AB

Total immunoglobulin M (IgM total) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 07333066010748
• NIH Device Record Key: af7cc688-fd7a-41e6-87fb-d78b7387fa7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EliA IgM Calibrator Well
• Version Model Number: DECC055270
• Catalog Number: DECC055270
• 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	07333066010748 [Package]; Contains: 07333066014708; Package: [4 Units]; In Commercial Distribution
GS1	07333066014708 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091845

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: 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 IgM Calibrator Well]

• 07333066010748: EliA IgM Calibrator Well
• 07333066024035: EliA IgM Calibrator Well