CHROMA ATE

GUDID 04719889100102

The GenXplore® system is an automated qPCR-based nucleic acid testing system. It can perform nucleic acid extraction, liquid handling, thermal cycling, and real-time fluorescence detection for testing nucleic acids from human samples, specifically for in vitro diagnostic purposes. The GenXplore® system is intended for professional use only and indoor use only.

CHROMA ATE INC.

Thermal cycler nucleic acid amplification analyser IVD, laboratory

• Primary Device ID: 04719889100102
• NIH Device Record Key: d5e5c188-0a31-4f9b-b0cb-c07c96c5eeb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHROMA ATE
• Version Model Number: GenXplore q4800
• Company DUNS: 656164662
• Company Name: CHROMA ATE INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	04719889100102 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-05
• Device Publish Date: 2024-07-26

On-Brand Devices [CHROMA ATE]

• 04719889100010: MagXtract 3200 Automated Nucleic Acid Extraction System The MagXtract 3200 system is an automate
• 04719889100102: The GenXplore® system is an automated qPCR-based nucleic acid testing system. It can perform nu