Neonatal Phenylalanine kit NP-4000

GUDID 06438147001293

For the quantitative determination of phenylalanine in dried blood.

Wallac Oy

Phenylalanine IVD, kit, fluorimetry

• Primary Device ID: 06438147001293
• NIH Device Record Key: c58848e4-8625-463e-a948-5ad7d0374520
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neonatal Phenylalanine kit
• Version Model Number: NP-4000
• Catalog Number: NP-4000
• 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	06438147001293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K943547

FDA Product Code

• JNB: Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-02-02

On-Brand Devices [Neonatal Phenylalanine kit]

• 06438147001293: For the quantitative determination of phenylalanine in dried blood.
• 06438147001286: For the quantitative determination of phenylalanine in dried blood.