LIAISON NES® Instrument NES1001

GUDID 10816101025142

DIASORIN MOLECULAR LLC

Thermal cycler nucleic acid amplification analyser IVD, laboratory

• Primary Device ID: 10816101025142
• NIH Device Record Key: 95e8aee9-27c0-43b7-9d55-dee7dbf473f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIAISON NES® Instrument
• Version Model Number: NES1001
• Catalog Number: NES1001
• Company DUNS: 080271715
• Company Name: DIASORIN MOLECULAR LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 1-562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 1-562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 1-562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 1-562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 1-562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 1-562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 1-562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 1-562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 1-562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 1-562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 1-562-240-6500
• Email: TS.Molecular@DiaSorin.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10816101025142 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251978

FDA Product Code

• OOI: Real Time Nucleic Acid Amplification System

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: 2026-01-30
• Device Publish Date: 2026-01-22

Devices Manufactured by DIASORIN MOLECULAR LLC

• 10816101025142 - LIAISON NES® Instrument: 2026-01-30
• 10816101025142 - LIAISON NES® Instrument: 2026-01-30
• 10816101025159 - LIAISON NES® Instrument (Refurbished): 2026-01-30
• 20816101029031 - LIAISON NES® FLU A/B, RSV & COVID-19: 2026-01-30
• 20816101029048 - LIAISON NES® FLU A/B, RSV & COVID-19 Control Swab Kit: 2026-01-30
• 20816101027358 - Simplexa COVID-19 / Flu A/B & RSV Direct: 2026-01-22
• 20816101027365 - Simplexa COVID-19 / Flu A/B & RSV Positive Control Pack: 2026-01-22
• 10816101020772 - R. rickettsii Substrate Slide: 2025-12-24
• 10816101027375 - Blastomyces Primer Pair: 2025-12-24