ReadiMag Pathogen Nucleic Acid Isolation Kit 3000000000359

GUDID 06973685471912

The ReadiMag Pathogen Nucleic Acid Isolation Kit is a system that uses magnetic beads technology for isolation and purification of Pathogen nucleic acid from biological specimens. 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: 06973685471912
• NIH Device Record Key: 197a12e3-a3f2-476c-9732-1be5f9fd610d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReadiMag Pathogen Nucleic Acid Isolation Kit
• Version Model Number: 32 Tests
• Catalog Number: 3000000000359
• 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	06973685471912 [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: 2022-08-01
• Device Publish Date: 2022-07-22

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

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• 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: 2022-09-28 The device is used for extraction and purification of nucleic acid in clinical samples.
• 06973685471912 - ReadiMag Pathogen Nucleic Acid Isolation Kit: 2022-08-01The ReadiMag Pathogen Nucleic Acid Isolation Kit is a system that uses magnetic beads technology for isolation and purification of Pathogen nucleic acid from biological specimens. 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.
• 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