510(k) K131728

QUIDEL MOLECULAR INFLUENZA A + B ASSAY by Quidel Corp. — Product Code OZE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 29, 2013
Date Received: June 12, 2013
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Influenza A And Influenza B Multiplex Nucleic Acid Assay
Device Class: Class II
Regulation Number: 866.3980
Review Panel: MI
Submission Type

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.

Other clearances by Quidel Corp.

K131813 — QUIDEL MOLECULAR RSV + HMPV ASSAY (September 6, 2013)
K130398 — SOFIA(R) RSV FIA (August 13, 2013)
K131166 — SOFIA(R) HCG FIA (August 2, 2013)
K131606 — SOFIA INFLUENZA A+B FIA (July 5, 2013)
K131619 — QUICKVUE INFLUENZA A+B (June 28, 2013)
K123998 — QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY (March 8, 2013)
K122189 — QUIDEL MOLECULAR RSV + HMPV ASSAY (March 8, 2013)
K113777 — QUIDEL MOLECULAR INFLUENZA A+B (March 15, 2012)
K112172 — QUIDEL MOLECULAR INFLUENZA A + B ASSAY (December 22, 2011)
K112490 — QUIDEL MOLECULAR HMPV ASSAY (December 15, 2011)

Other clearances for product code OZE

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K241110 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtypi (May 21, 2024)
K230236 — Lyra Influenza A+B Assay (March 3, 2023)
K220801 — ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 (June 24, 2022)
K200370 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typin (March 10, 2020)
K182513 — FluChip-8G Influenza A+B Assay (April 22, 2019)
K190302 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typin (March 27, 2019)
K190204 — ID NOW Influenza A & B 2 (March 18, 2019)
K181736 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage (July 30, 2018)