Fluorescence Quantitative PCR Detection System

GUDID 06975318150119

ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.

Thermal cycler nucleic acid amplification analyser IVD, point-of-care

• Primary Device ID: 06975318150119
• NIH Device Record Key: d5895286-7f17-402b-993f-be255578aef9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fluorescence Quantitative PCR Detection System
• Version Model Number: MQ4084-8
• Company DUNS: 723289634
• Company Name: ANITOA BIOTECHNOLOGY(HANGZHOU)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: 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	06975318150119 [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: 2022-12-06
• Device Publish Date: 2022-11-28

On-Brand Devices [Fluorescence Quantitative PCR Detection System]

• 06975318150126: MQ4162-16
• 06975318150119: MQ4084-8
• 06975318150102: MQ4082-8
• 06975318150096: MQ4044-4
• 06975318150089: MQ4042-4
• 06975318150072: MQ4164-16
• 06975318150065: MQ4162-16
• 06975318150058: MQ4084-8
• 06975318150041: MQ4082-8
• 06975318150034: MQ4044-4
• 06975318150027: MQ4042-4
• 06975318150010: MQ4164-16