AutoDELFIA Neonatal hTSH kit B032-312

GUDID 06438147140473

Time-resolved fluoroimmunoassay for the quantitative determination of human thyrotropin (thyroid stimulating hormone - hTSH) in dried blood.

Wallac Oy

Neonatal thyroid stimulating hormone (neonatal TSH) IVD, kit, fluorescent immunoassay

• Primary Device ID: 06438147140473
• NIH Device Record Key: 52e13b8a-bc67-4966-a805-290fb35da95b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AutoDELFIA Neonatal hTSH kit
• Version Model Number: B032-312
• Catalog Number: B032-312
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438147140473 [Primary]

FDA Product Code

• JLW: Radioimmunoassay, Thyroid-Stimulating Hormone

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: 2016-06-30

On-Brand Devices [AutoDELFIA Neonatal hTSH kit]

• 06438147179596: Time-resolved fluoroimmunoassay for the quantitative determination of human thyrotropin (thyroid
• 06438147140473: Time-resolved fluoroimmunoassay for the quantitative determination of human thyrotropin (thyroid