NeoBase 2 Non-derivatized Assay Solutions 3045-0010

GUDID 06438147348107

NeoBase™ 2 Non-derivatized Assay Solutions are intended for in vitro diagnostic use with the NeoBase 2 Non-derivatized MSMS kit to extract target analytes from blood samples dried on filter paper and to carry target analytes to the MSMS system.

Wallac Oy

Multiple amino acid/carnitine metabolite IVD, kit, mass spectrometry

• Primary Device ID: 06438147348107
• NIH Device Record Key: 35dab8d3-b71d-41be-998f-d87a26fead89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoBase 2 Non-derivatized Assay Solutions
• Version Model Number: 3045-0010
• Catalog Number: 3045-0010
• 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: true
• 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 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438147348107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173568

FDA Product Code

• NQL: System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry

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: 2020-04-30
• Device Publish Date: 2019-02-25

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