ANDiS Viral Nucleic Acid Auto Extraction and Purification Pooling Kit 3103010040

GUDID 06973685471035

The ANDiS Viral Nucleic Acid Auto Extraction and Purification Pooling kit is a system that uses automatic magnetic beads technology for isolation and purification of viral RNA from biological specimens (nasopharyngeal, oropharyngeal swabs or anterior nasal swab). The purified nucleic acids can be directly used for the downstream tests. The product is intended to be used by professional users, such as technicians and physicians who are trained in molecular biological techniques.

3D Biomedicine Science & Technology Co., Limited

Nucleic acid extraction/isolation kit IVD

• Primary Device ID: 06973685471035
• NIH Device Record Key: 96492ef8-9206-4dc3-9094-e9831165c44d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANDiS Viral Nucleic Acid Auto Extraction and Purification Pooling Kit
• Version Model Number: 64Tests
• Catalog Number: 3103010040
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973685471035 [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: 2021-12-08
• Device Publish Date: 2021-11-30

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