Diomni™ Software, Version 4.1.0

GUDID 10190302019514

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

Laboratory instrument/analyser application software IVD

• Primary Device ID: 10190302019514
• NIH Device Record Key: 480e3771-9d5b-437e-84bd-991c43c583fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diomni™ Software, Version 4.1.0
• Version Model Number: A59789
• Company DUNS: 628548377
• Company Name: LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
• 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: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190302019514 [Primary]

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: 2024-05-06
• Device Publish Date: 2024-04-26

Devices Manufactured by LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

• 10190302019897 - Applied BioSystems™ ABY™ Dye Spectral Calibration Plate for Multiplex qPCR, Fast: 2025-08-27 Applied Biosystems ABY Dye Spectral Calibration Plate for Multiplex qPCR used for ABY dye spectral calibration of the Applied Bi
• 10190302019903 - Applied BioSystems™ JUN™ Dye Spectral Calibration Plate for Multiplex qPCR, Fast: 2025-08-27 Applied Biosystems JUN Dye Spectral Calibration Plate for Multiplex qPCR used for JUN dye spectral calibration of the Applied Bi
• 10190302018883 - Ion Torrent Genexus Dx Software: 2025-08-01 Ion Torrent Genexus Dx Software
• 10190302019859 - Diomni™ Software, Version 4.2.0: 2025-05-12
• 10190302019958 - Torrent Suite DX SW, Installer V5.14.2: 2025-02-27 Torrent Suite Dx SW, Installer V5.14.2
• 10190302007399 - Array Card Clip: 2024-06-04 VIIA 7 DX ARRAY CARD BUCKET
• 10190302019514 - Diomni™ Software, Version 4.1.0: 2024-05-06
• 10190302019514 - Diomni™ Software, Version 4.1.0: 2024-05-06
• 10190302019231 - KingFisher™ Apex Dx Purification Instrument: 2023-08-11