ImmunoCAP Autoimmunity Specific IgG Sample Diluent 34-2325-31

GUDID 07333066000411

ImmunoCAP Autoimmunity Specific IgG Sample Diluent

Phadia AB

Plasma protein IVD, reagent

• Primary Device ID: 07333066000411
• NIH Device Record Key: cefe6fe2-94b6-4397-bec1-5a644507950e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImmunoCAP Autoimmunity Specific IgG Sample Diluent
• Version Model Number: 34-2325-31
• Catalog Number: 34-2325-31
• 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: 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	07333066000411 [Package]; Contains: 07333066019857; Package: [6 Units]; In Commercial Distribution
GS1	07333066019857 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072661

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: 2019-04-05
• Device Publish Date: 2019-03-28

On-Brand Devices [ImmunoCAP Autoimmunity Specific IgG Sample Diluent]

• 07333066000411: ImmunoCAP Autoimmunity Specific IgG Sample Diluent
• 07333066000749: ImmunoCAP Autoimmunity Specific IgG Sample Diluent