Dilution Well 12-4005-69

GUDID 07333066019680

Dilution Well

Phadia AB

Plasma protein IVD, reagent

• Primary Device ID: 07333066019680
• NIH Device Record Key: bdcb4f20-2e8e-446d-845a-88d1aedd8220
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dilution Well
• Version Model Number: 12-4005-69
• Catalog Number: 12-4005-69
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07333066019680 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051218

FDA Product Code

• DHB: System, test, radioallergosorbent (rast) immunological

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: 2019-04-03
• Device Publish Date: 2019-03-26

On-Brand Devices [Dilution Well]

• 07333066010878: Dilution Well
• 07333066019680: Dilution Well