GenASIs™ System

GUDID 07290016630008

APPLIED SPECTRAL IMAGING LTD.

Laboratory analyser operation system software IVD

• Primary Device ID: 07290016630008
• NIH Device Record Key: a73e2a2b-ee70-44a1-b751-e59e7e8059af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GenASIs™ System
• Version Model Number: GenASIs
• Company DUNS: 600741763
• Company Name: APPLIED SPECTRAL IMAGING LTD.
• 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: true
• 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	07290016630008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012103

FDA Product Code

• NTH: System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays

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: 2017-01-12

On-Brand Devices [GenASIs™ System]

• 07290016630015: GenASIs
• 07290016630008: GenASIs