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

Nucleic acid sample preparation instrument IVD

• 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

Devices Manufactured by 3D Biomedicine Science & Technology Co., Limited

• 06973685471387 - ReadiMag™ gDNA Isolation Kit: 2024-01-23 The ReadiMag™ gDNA Isolation Kit utilizes magnetic beads-based technology for isolation and purification of genomic DNA from b
• 06973685471325 - ReadiMag FFPE DNA/RNA Kit: 2023-10-03 The ReadiMag FFPE DNA/RNA Kit utilizes magnetic beads-based technology for isolation and purification of genomic DNA/RNA from fo
• 06973685471332 - ReadiMag™ FFPE DNA Isolation Kit: 2023-09-05 The ReadiMag™ FFPE DNA Isolation Kit utilizes magnetic beads-based technology for isolation and purification of genomic DNA fr
• 06973685471394 - 96A Automated Viral DNA/RNA Isolation Kit: 2022-10-10 96A Automated Viral DNA/RNA Isolation Kit is intended for isolation and purification of viral DNA and RNA from biological specim
• 06973685478027 - Automated Nucleic Acids Extraction System ANDiS 396: 2022-09-28The device is used for extraction and purification of nucleic acid in clinical samples.
• 06973685478027 - Automated Nucleic Acids Extraction System ANDiS 396: 2022-09-28 The device is used for extraction and purification of nucleic acid in clinical samples.
• 06973685471912 - ReadiMag Pathogen Nucleic Acid Isolation Kit: 2022-08-01 The ReadiMag Pathogen Nucleic Acid Isolation Kit is a system that uses magnetic beads technology for isolation and purification
• 06973685471356 - 96A Automated Viral DNA/RNA Isolation Kit: 2022-06-21 96A Automated Viral DNA/RNA Isolation Kit is intended for isolation and purification of viral DNA and RNA from biological specim
• 06973685471189 - ReadiMag FFPE DNA Kit: 2022-06-03 The ReadiMag FFPE DNA Kit utilizes magnetic beads-based technology for isolation and purification of genomic DNA from formalin-f