ASI IVD System

GUDID 07290016630039

ASI IVD System with software version GenASIs V-8.3

APPLIED SPECTRAL IMAGING LTD.

Laboratory analyser operation system software IVD

• Primary Device ID: 07290016630039
• NIH Device Record Key: f23220a8-c124-4226-a514-1764ebfbe01c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASI IVD System
• Version Model Number: GenASIs 8.3
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016630039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012103

FDA Product Code

• JOY: Device, Automated Cell-Locating

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-29
• Device Publish Date: 2022-03-21

On-Brand Devices [ASI IVD System]

• 07290016630039: ASI IVD System with software version GenASIs V-8.3
• 07290016630046: ASI IVD System with software version GenASIs V-8.4