TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative Control

GUDID 10190302019040

Component 3 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)

LIFE TECHNOLOGIES CORPORATION

Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 10190302019040
• NIH Device Record Key: bb0e04ff-54a5-4e3d-ad1b-f85edd2aa363
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative Control
• Version Model Number: 963608
• Company DUNS: 790376870
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	10190302019040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241806

FDA Product Code

• QOF: Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

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: 2025-02-25
• Device Publish Date: 2025-02-17

On-Brand Devices [TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative Control]

• 10190302019040: Component 3 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select
• 10190302019002: Component 3 of 4 of A56123 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select