NeoBase Non-derivatized Assay Solutions 3041-0020

GUDID 06438147295692

This reagent package is intended for sample processing in the assay of in vitro measurement and evaluation of the concentrations of amino acids, succi

Wallac Oy

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

• Primary Device ID: 06438147295692
• NIH Device Record Key: aeac7032-350b-42f3-b05b-e343587c5397
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoBase Non-derivatized Assay Solutions
• Version Model Number: 3041-0020
• Catalog Number: 3041-0020
• 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 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438147295692 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083130

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: 5
• Public Version Date: 2018-12-13
• Device Publish Date: 2016-02-11

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