1 device · 1 company · 2019
Product code OZE: Influenza A And Influenza B Multiplex Nucleic Acid Assay
1 device under product code OZE, 2019, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Influenza A And Influenza B Multiplex Nucleic Acid Assay. 21 CFR 866.3980, Class II. 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. MAUDE held 5 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| FluChip-8G Influenza A+B AssayK182513 · 510(k) | InDevR, Inc. | Microbiology | database entry |
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