Simplicity TM Dx Extraction System

GUDID 06973843220819

For the detail information, please refer to the IFU.

Hangzhou Bioer Technology Co., Ltd.

Nucleic acid sample preparation instrument IVD

• Primary Device ID: 06973843220819
• NIH Device Record Key: a52a02a4-d6a4-4ee3-b706-61048b0f7de7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simplicity TM Dx Extraction System
• Version Model Number: EQP-ETR-MD32
• Company DUNS: 545256935
• Company Name: Hangzhou Bioer Technology 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	06973843220819 [Primary]

FDA Product Code

• JJH: Clinical Sample Concentrator

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: 2024-07-09
• Device Publish Date: 2024-07-01

Devices Manufactured by Hangzhou Bioer Technology Co., Ltd.

• 06973843220802 - careSTART™ Q1 Amplifier: 2025-02-19 For the detail information, please refer to the IFU.
• 06973843220864 - GenePure Pro 16H Nucleic Acid Purification System: 2025-02-19 For the detail information, please refer to the IFU.
• 06973843220871 - Thermo Cell Mixing Block: 2025-02-19 For the detail information, please refer to the IFU.
• 06973843220888 - Thermo Shaker Mixing Block: 2025-02-19 For the detail information, please refer to the IFU.
• 06973843220895 - ThermoQ: 2025-02-19 For the detail information, please refer to the IFU.
• 06973843220901 - ThermoQ: 2025-02-19 For the detail information, please refer to the IFU.
• 06973843220918 - ThermoQ: 2025-02-19 For the detail information, please refer to the IFU.
• 06973843220925 - ThermoQ: 2025-02-19 For the detail information, please refer to the IFU.