ELITe InGenius® INT030-K

GUDID 03661540900006

The ELITe InGenius® system is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests. The ELITe InGenius system is a fully automated device integrating extraction and purification of nucleic acids from multiple sample types, amplification and detection of the target sequence by real-time Polymerase Chain Reaction (PCR), and result interpretation. ELITe InGenius® is FDA cleared only for use in association with HSV 1&2 ELITe MGB® Assay

ELITECHGROUP SPA

Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated

• Primary Device ID: 03661540900006
• NIH Device Record Key: 34b812de-31c3-4f2f-9bdb-1919dd783892
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELITe InGenius®
• Version Model Number: INT030-K
• Catalog Number: INT030-K
• Company DUNS: 434528644
• Company Name: ELITECHGROUP SPA
• Device Count: 1
• DM Exempt: true
• 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: true
• 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	03661540900006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180559

FDA Product Code

• OOI: Real Time Nucleic Acid Amplification System

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: 2020-07-07
• Device Publish Date: 2019-01-09