Automated Nucleic Acids Extraction System ANDiS 350 3105020002

GUDID 06973685478003

A mains electricity (AC-powered) laboratory instrument intended to be used for the automated pre-analytical preparation of samples for downstream nucleic acid analysis. The instrument may be used to prepare various sample types through one or more pre-analytical steps which may include cell disruption, lysis, nucleic acid extraction, enzymatic digestion and/or nucleic acid purification. The device operates with minimal technician involvement and complete automation of all procedural steps.

3D Biomedicine Science & Technology Co., Limited

Nucleic acid sample preparation instrument IVD, automated

• Primary Device ID: 06973685478003
• NIH Device Record Key: ccc543e9-b850-466f-904c-fdd17d6a2369
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Automated Nucleic Acids Extraction System ANDiS 350
• Version Model Number: ANDiS 350
• Catalog Number: 3105020002
• 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	06973685478003 [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: 2021-01-20
• Device Publish Date: 2021-01-12

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