QuantStudio Dx Emerging Pathogens Edition Software Version 1.0.1

GUDID 10190302006736

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD

• Primary Device ID: 10190302006736
• NIH Device Record Key: 99aca19c-4368-4d9d-a2d6-562996326d8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuantStudio Dx Emerging Pathogens Edition Software Version 1.0.1
• Version Model Number: 1.0.1
• 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	10190302006736 [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: 2019-07-11
• Device Publish Date: 2019-07-03

Devices Manufactured by LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

• 10190302019514 - Diomni™ Software, Version 4.1.0: 2024-05-06
• 10190302019231 - KingFisher™ Apex Dx Purification Instrument: 2023-08-11
• 10190302019248 - KingFisher™ Apex Dx 96 PCR Head: 2023-08-11
• 10190302019255 - KingFisher™ Apex Dx 96 Combi Head: 2023-08-11
• 10190302019262 - KingFisher™ Apex Dx 96 Deep Well Head: 2023-08-11
• 10190302019279 - KingFisher™ Apex Dx 24 Combi Head: 2023-08-11
• 10190302019408 - Diomni™ Software, Version 4.0.0: 2023-07-20
• 10190302018944 - VeritiPro Dx Thermal Cycler: 2023-06-02