Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control

Basic Information

• Brand Name: Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control
• Primary DI: 10190302019446
• Version / Model: 966136
• Company Name: LIFE TECHNOLOGIES CORPORATION
• Labeler DUNS: 790376870
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2025-02-17
• Public Version: 1
• Public Version Date: 2025-02-25
• Public Version Status: New
• Public Device Record Key: 65b840aa-4a0c-408f-8876-2d1fcc9dc831

Device Description

Part 2 of 3 of TaqPath™ COVID-19 Diagnostic PCR Kit REF A58505

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QQX	Respiratory Specimen Nucleic Acid Sars-Cov-2 Test	Microbiology	866.3981	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64747	SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a nucleic acid technique (NAT). This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10190302019446	GS1
Unit of Use	80190302019445	GS1

Premarket Submissions

Submission Number	Supplement Number
K233453	000