Nextractor NX-Duo

GUDID 08800174502742

GENOLUTION. INC.

Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD

• Primary Device ID: 08800174502742
• NIH Device Record Key: f735efe2-198d-4b73-9218-37c2c1f524c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nextractor NX-Duo
• Version Model Number: NX-Duo
• Company DUNS: 688418843
• Company Name: GENOLUTION. INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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	08800174502742 [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: 2023-11-02
• Device Publish Date: 2023-10-25

Devices Manufactured by GENOLUTION. INC.

• 08800174502988 - NX Universal NA Kit A NUE961: 2023-11-16
• 08800174502995 - NX Universal NA Kit A NUE321: 2023-11-16
• 08800174503008 - NX Universal NA Kit A NUE041: 2023-11-16
• 08800174503015 - NX Universal DNA Kit B NUE962: 2023-11-16
• 08800174503022 - NX Universal DNA Kit B NUE322: 2023-11-16
• 08800174503039 - NX Universal DNA Kit B NUE042: 2023-11-16
• 08800174503046 - NX Universal DNA Kit C NUE963: 2023-11-16
• 08800174503053 - NX Universal DNA Kit C NUE323: 2023-11-16