Sample Preservative Fluid

GUDID 06973843228914

The Sample Preservative Fluid is intended for the stabilization, transportation, and inactivation of infectious, unprocessed, upper respiratory specimens suspected of containing Influenza A virus. Specimens transported in the Sample Preservative Fluid are stable refrigerated (2-8°C) and at room temperature (20-25°C). The Sample Preservative Fluid is suitable for use with compatible legally marketed molecular diagnostic devices.

Hangzhou Bioer Technology Co., Ltd.

General specimen collection kit IVD, clinical

• Primary Device ID: 06973843228914
• NIH Device Record Key: 99877d6f-ef9a-4484-8960-e34cca4fb999
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 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: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973843228914 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222771

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-23
• Device Publish Date: 2024-07-15

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.