Automated Nucleic Acids Extraction System ANDiS 396 3000000000414

GUDID 06973685478027

The device is used for extraction and purification of nucleic acid in clinical samples.

3D Biomedicine Science & Technology Co., Limited

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• Primary Device ID: 06973685478027
• NIH Device Record Key: 4bf5e4d4-fcce-410f-99c7-9a7e53692167
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Automated Nucleic Acids Extraction System ANDiS 396
• Version Model Number: ANDiS 396
• Catalog Number: 3000000000414
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	06973685478027 [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: 2022-09-28
• Device Publish Date: 2022-09-20

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