CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K243931 ↗

FDA Product Code

OZE

Models / Variants

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2)

Influenza A Subtyping Kit (VER 4)

Influenza B Lineage Genotyping Kit (VER 1.1 and 2)

and Influenza A/H5 Subtyping Kit (VER 4)

Device Class

Class II

Regulation

21 CFR Part 866.3980

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit

  Class II

  FDA 510(k) K190302 Active Cleared 27 Mar 2019

See all devices from Centers for Disease Control and Prevention →

• What types of influenza viruses can this diagnostic panel detect and differentiate, and how does it achieve this?

  This panel detects, types, and subtypes human influenza viruses using real-time RT-PCR technology. It distinguishes between Influenza A and B viruses, further subtyping Influenza A (including H5) and genotyping Influenza B lineages. The kits are designed to provide precise viral characterization, enabling accurate epidemiological and clinical analysis for better patient management and outbreak tracking.

• Is this device intended for single-use, or can it be reused across multiple tests? If reusable, how is sterility ensured?

  The CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel is not single-use. Instead, it is supplied as a reagent kit for in vitro diagnostic testing, requiring validation for each batch. Sterility is maintained through manufacturer-controlled processes, ensuring reliability for repeated use in clinical microbiology laboratories when properly validated.

• What regulatory pathways has this device followed, and what classification does it hold under medical device regulations?

  This device has followed the FDA 510(k) clearance pathway and adheres to the In Vitro Diagnostic Device Directive (IVDD) regulations. It is classified as a Class II medical device under FDA code 866.3980, which reflects its intended use in molecular diagnostics for influenza detection and subtyping.

• Where is this device manufactured, and who is the responsible applicant for regulatory submissions?

  The device is manufactured by the Centers for Disease Control and Prevention (CDC), headquartered at 1600 Clifton Rd., Atlanta, GA 30329. The CDC itself serves as the applicant for regulatory submissions, including the FDA 510(k) clearance process.

• How should this diagnostic panel be stored, and are there any special handling requirements for its components?

  While specific storage instructions are not detailed in the provided data, as a reagent kit for molecular diagnostics, this panel should be stored according to the manufacturer’s guidelines to maintain stability and performance. Typically, such kits require refrigeration or freezing (e.g., -20°C) until use, with protection from light and contamination. Always refer to the included package insert for precise storage conditions.