TaqPath™ COVID-19, Flu A, Flu B, RSV Select Assay

GUDID 10190302018982

Component 1 of 4 of A56123 (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: 10190302018982
• NIH Device Record Key: 8d4a0c89-d337-4f03-b207-d22cfe2cc779
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TaqPath™ COVID-19, Flu A, Flu B, RSV Select Assay
• Version Model Number: A56440
• 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	10190302018982 [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 Assay]

• 10190302019026: Component 1 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select
• 10190302018982: Component 1 of 4 of A56123 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select