AutoDELFIA Unconjugated Estriol (uE3) kit B095-112

GUDID 06438147355037

Time-resolved fluoroimmunoassay for the quantitative determination of unconjugated estriol (uE3).

Wallac Oy

Free estriol (oestriol) IVD, kit, fluorescent immunoassay

• Primary Device ID: 06438147355037
• NIH Device Record Key: e4c988d9-14c6-442b-97af-00a995cf70a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AutoDELFIA Unconjugated Estriol (uE3) kit
• Version Model Number: B095-112
• Catalog Number: B095-112
• 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: true
• 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	06438147355037 [Primary]

FDA Product Code

• CGI: Radioimmunoassay, Estriol

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: 2018-12-17
• Device Publish Date: 2018-11-16

On-Brand Devices [AutoDELFIA Unconjugated Estriol (uE3) kit]

• 06438147355037: Time-resolved fluoroimmunoassay for the quantitative determination of unconjugated estriol (uE3)
• 06438147355013: Time-resolved fluoroimmunoassay for the quantitative determination of unconjugated estriol (uE3)
• 06438147119745: Time-resolved fluoroimmunoassay for the quantitative determination of unconjugated estriol (uE3)
• 06438147119332: Time-resolved fluoroimmunoassay for the quantitative determination of unconjugated estriol (uE3)