BIOER Sample Preservative Fluid

GUDID 06973843228143

For the detail information, please refer to the IFU.

Hangzhou Bioer Technology Co., Ltd.

General specimen container IVD, additive/medium

• Primary Device ID: 06973843228143
• NIH Device Record Key: 7bc7614e-6cc4-4385-be13-28df79c3f885
• Commercial Distribution Discontinuation: 2024-07-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BIOER Sample Preservative Fluid
• Version Model Number: BSC82X1-A1
• 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: true
• Serial Number: true
• Manufacturing Date: false
• 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	06973843228143 [Primary]

FDA Product Code

• QBD: Microbial Nucleic Acid Storage And Stabilization Device

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: 2024-07-04
• Device Publish Date: 2023-01-11

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.