AutoDELFIA Neonatal Thyroxine (T4) kit B065-01C

GUDID 06438147179602

Time-resolved fluoroimmunoassay for the quantitative determination of thyroxine (T4) in dried blood.

Wallac Oy

Neonatal thyroxine (neonatal T4) IVD, kit, fluorescent immunoassay

• Primary Device ID: 06438147179602
• NIH Device Record Key: 0e501187-afc5-48cc-9d86-af8c38b6b2b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AutoDELFIA Neonatal Thyroxine (T4) kit
• Version Model Number: B065-01C
• Catalog Number: B065-01C
• Company DUNS: 540156544
• Company Name: Wallac Oy
• 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: true
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438147179602 [Primary]

FDA Product Code

• CDX: Radioimmunoassay, Total Thyroxine

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-02-02

On-Brand Devices [AutoDELFIA Neonatal Thyroxine (T4) kit]

• 06438147179602: Time-resolved fluoroimmunoassay for the quantitative determination of thyroxine (T4) in dried bl
• 06438147009589: Time-resolved fluoroimmunoassay for the quantitative determination of thyroxine (T4) in dried bl