Chrysalis Intelligence · Product Codes · OZE

OZE · Influenza A And Influenza B Multiplex Nucleic Acid Assay

Microbiology · 6 clearances · 3 unique sponsors

Device class
Class II
Regulation 866.3980
Total clearances
6
2020-03-10 → 2025-07-11
Last 12 months
0
Unique sponsors
3
Definition

What is Influenza A And Influenza B Multiplex Nucleic Acid Assay

An Influenza A and Influenza B multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of influenza A and influenza B nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of influenza A and B nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract influenza viral infections if used in conjunction with other clinical and laboratory findings.
Medical specialty
Microbiology
Review panel
MI
Regulation number
866.3980
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Centers for Disease Control and Prevention 4 0 2025-07-11
Abbott Diagnostics Scarborough, Inc. 1 0 2022-06-24
Quidel Corporation 1 0 2023-03-03
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
87502 CPT — High Influenza A and B nucleic acid assay with multiple primers/probes; standard multiplex influenza testing code
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-07-11 K243274 Centers for Disease Control and Prevention 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)
2025-03-14 K243931 Centers for Disease Control and Prevention 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)
2024-05-21 K241110 Centers for Disease Control and Prevention CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)
2023-03-03 K230236 Quidel Corporation Lyra Influenza A+B Assay
2022-06-24 K220801 Abbott Diagnostics Scarborough, Inc. ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
2020-03-10 K200370 Centers for Disease Control and Prevention 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 A/H5 Subtyping Kit