QuantStudio(TM) Dx Software Version 1.0.4

GUDID 10190302015615

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

Laboratory instrument/analyser application software IVD

• Primary Device ID: 10190302015615
• NIH Device Record Key: 4caeacc1-d859-4a58-ab5d-a0c7618db143
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuantStudio(TM) Dx Software Version 1.0.4
• Version Model Number: A48389
• Company DUNS: 628548377
• Company Name: LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
• 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: 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	10190302015615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123955

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: 2021-04-27
• Device Publish Date: 2021-04-19

Devices Manufactured by LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

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• 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
• 10190302019231 - KingFisher™ Apex Dx Purification Instrument: 2023-08-11