Nextractor NX-Duo

GUDID 08800174502742

GENOLUTION. INC.

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