Genetic Screening Processor 2021-0010

GUDID 06438147311040

The GSP® instrument is a fully automated, high throughput batch analyzer for time-resolved and prompt fluorescence analysis of samples in microtitrati

Wallac Oy

Fluorescent immunoassay analyser IVD, laboratory, automated Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory

• Primary Device ID: 06438147311040
• NIH Device Record Key: 99744322-967c-48af-9d27-6d4e92e1c160
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genetic Screening Processor
• Version Model Number: 2021-0010
• Catalog Number: 2021-0010
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438147311040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090846

FDA Product Code

• KHO: Fluorometer, For Clinical Use

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: 2016-06-30

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