QuantStudio Dx Software V1.0.3, Kit

GUDID 10190302006729

LIFE TECHNOLOGIES CORPORATION

Laboratory instrument/analyser application software IVD

• Primary Device ID: 10190302006729
• NIH Device Record Key: 2395d344-bfe8-41fd-ab95-987e117c666b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuantStudio Dx Software V1.0.3, Kit
• Version Model Number: 1.0.3
• Company DUNS: 080131636
• Company Name: LIFE TECHNOLOGIES CORPORATION
• 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: 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	10190302006729 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-04-15
• Device Publish Date: 2018-07-13

Devices Manufactured by LIFE TECHNOLOGIES CORPORATION

• 10190302018982 - TaqPath™ COVID-19, Flu A, Flu B, RSV Select Assay: 2025-02-25 Component 1 of 4 of A56123 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
• 10190302018999 - TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive Control: 2025-02-25 Component 2 of 4 of A56123 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
• 10190302019002 - TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative Control: 2025-02-25 Component 3 of 4 of A56123 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
• 10190302019019 - TaqPath™ 1-Step Select Master Mix (No ROX): 2025-02-25 Component 4 of 4 of A56123 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
• 10190302019026 - TaqPath™ COVID-19, Flu A, Flu B, RSV Select Assay: 2025-02-25 Component 1 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
• 10190302019033 - TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive Control: 2025-02-25 Component 2 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
• 10190302019040 - TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative Control: 2025-02-25 Component 3 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
• 10190302019057 - TaqPath™ 1-Step Select Master Mix (No ROX): 2025-02-25 Component 4 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)