Easy Amp Real-time Fluorescence Isothermal Detection System

GUDID 06974849369083

Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

Thermal cycler nucleic acid amplification analyser IVD, laboratory

• Primary Device ID: 06974849369083
• NIH Device Record Key: 92c7b0de-06e7-4051-971d-0bc3348765b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy Amp Real-time Fluorescence Isothermal Detection System
• Version Model Number: HWTS-1600P
• Company DUNS: 560300737
• Company Name: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
• 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: true
• 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	06974849369083 [Primary]

FDA Product Code

• NSU: Instrumentation For Clinical Multiplex Test Systems

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: 2022-12-14
• Device Publish Date: 2022-12-06

On-Brand Devices [Easy Amp Real-time Fluorescence Isothermal Detection System]

• 06974849369083: HWTS-1600P
• 06974849369076: HWTS-1600S