Simplicity TM Dx Extraction Kit

GUDID 06973843228884

DNA/RNA Extraction / purification For the detail information, please refer to the IFU.

Hangzhou Bioer Technology Co., Ltd.

Nucleic acid extraction/isolation kit IVD

• Primary Device ID: 06973843228884
• NIH Device Record Key: d31a7993-e0bc-4fa7-9da0-969f421ba092
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simplicity TM Dx Extraction Kit
• Version Model Number: EXT-DoR-MD100B
• 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	06973843228884 [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

On-Brand Devices [Simplicity TM Dx Extraction Kit ]

• 06973843228907: DNA/RNA Extraction / purification For the detail information, please refer to the IFU.
• 06973843228891: DNA/RNA Extraction / purification For the detail information, please refer to the IFU.
• 06973843228884: DNA/RNA Extraction / purification For the detail information, please refer to the IFU.