AutoDELFIA hAFP kit B079-212

GUDID 06438147321322

Time-resolved fluoroimmunoassay for the quantitative determination of human alphafetoprotein (hAFP)

Wallac Oy

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay

• Primary Device ID: 06438147321322
• NIH Device Record Key: 20a694f7-f6b6-4f8b-88b8-abe76859a464
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AutoDELFIA hAFP kit
• Version Model Number: B079-212
• Catalog Number: B079-212
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438147321322 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P970037

FDA Product Code

• LOK: Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-21
• Device Publish Date: 2014-09-24

On-Brand Devices [AutoDELFIA hAFP kit]

• 06438147321322: Time-resolved fluoroimmunoassay for the quantitative determination of human alphafetoprotein (hA
• 06438147321315: Time-resolved fluoroimmunoassay for the quantitative determination of human alpha-fetoprotein (h