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 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

K243274 ↗

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 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

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  FDA 510(k) K190302 Active Cleared 27 Mar 2019

See all devices from Centers for Disease Control and Prevention →

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

  This panel detects and differentiates Influenza A, Influenza B, and specific subtypes like Influenza A/H5 using real-time reverse transcription polymerase chain reaction (RT-PCR). It employs nucleic acid amplification to identify viral RNA sequences, allowing precise typing and subtyping for accurate diagnosis and epidemiological tracking. The panel includes separate kits for Influenza A/B typing, Influenza A subtyping, Influenza B genotyping, and Influenza A/H5 subtyping, each designed for targeted analysis.

• Is this kit intended for reuse, or is it meant for single-use only? What does this mean for laboratory workflows?

  The CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel is designed for single-use only. This means each kit must be used once per test run and cannot be reused, even if reagents remain. Laboratories must account for this in workflow planning, ensuring proper inventory management and adherence to sterility protocols to prevent cross-contamination. Single-use also aligns with regulatory guidelines for nucleic acid testing, minimizing risk.

• What storage conditions are required for the kits, and why are these important?

  While the exact storage temperatures aren’t specified in the provided data, the kits require adherence to specified temperature guidelines to maintain reagent integrity and assay performance. Improper storage—such as exposure to heat, freeze-thaw cycles, or light—can degrade nucleic acid targets or enzymes, leading to false-negative results or assay failure. Following storage instructions ensures reliable detection and subtyping of influenza viruses, critical for accurate clinical and epidemiological decision-making.

• Are these kits authorized for use in all clinical microbiology laboratories, or are there specific requirements?

  The kits are authorized for use in clinical microbiology laboratories under FDA 510(k) clearance and compliance with the In Vitro Diagnostic Device Directive (IVDD). However, laboratories must ensure they have the technical expertise, equipment (e.g., real-time RT-PCR machines), and infrastructure to perform nucleic acid amplification assays safely and accurately. The CDC’s authorization does not override the need for local validation and adherence to laboratory protocols, including biosafety and quality control measures.

• How do I determine which version of the kit (e.g., Ver 2, Ver 4) is appropriate for my diagnostic needs?

  The version number corresponds to specific typing or subtyping applications: for example, Ver 2 is for Influenza A/B typing, while Ver 4 applies to Influenza A subtyping and Influenza A/H5 subtyping. Choose the version based on whether you need general typing (A/B), subtyping of Influenza A, genotyping of Influenza B, or detection of the H5 subtype. The CDC’s documentation for each version outlines its intended use, so verify compatibility with your laboratory’s diagnostic workflow and epidemiological priorities.