96A Automated Viral DNA/RNA Isolation Kit 3000000000493

GUDID 06973685471394

96A Automated Viral DNA/RNA Isolation Kit is intended for isolation and purification of viral DNA and RNA from biological specimens (Nasopharyngeal Swabs, Oropharyngeal Swabs, Saliva and Cervical Swabs) by using automatic magnetic beads technology. The purified nucleic acids can be directly used for the downstream tests. The product is intended to be used by professional users, such as laboratory personnel who has been trained.

3D Biomedicine Science & Technology Co., Limited

Nucleic acid extraction/isolation kit IVD

• Primary Device ID: 06973685471394
• NIH Device Record Key: 14900b2b-fed0-4f52-91ae-a6f68c30fa62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 96A Automated Viral DNA/RNA Isolation Kit
• Version Model Number: 500 Tests
• Catalog Number: 3000000000493
• Company DUNS: 561011079
• Company Name: 3D Biomedicine Science & Technology Co., Limited
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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	06973685471394 [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: 2022-10-10
• Device Publish Date: 2022-10-02

On-Brand Devices [96A Automated Viral DNA/RNA Isolation Kit]

• 06973685471356: 96A Automated Viral DNA/RNA Isolation Kit is intended for isolation and purification of viral DN
• 06973685471394: 96A Automated Viral DNA/RNA Isolation Kit is intended for isolation and purification of viral DN