FDA 510(k)

QUIDEL MOLECULAR INFLUENZA A+B

K-Number: K113777 · 2012-03-15

Decision Date2012-03-15

Product CodeOZE

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

QUIDEL MOLECULAR INFLUENZA A+B is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 2012-03-15 under 510(k) number K113777. The device is classified under product code OZE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUIDEL MOLECULAR INFLUENZA A+B?

QUIDEL MOLECULAR INFLUENZA A+B is a medical device that received FDA 510(k) clearance on 2012-03-15. The listed applicant is Quidel Corp.. The 510(k) number is K113777.

When did QUIDEL MOLECULAR INFLUENZA A+B receive FDA 510(k) clearance?

QUIDEL MOLECULAR INFLUENZA A+B received FDA 510(k) clearance on 2012-03-15, under 510(k) number K113777.

Who is the listed applicant for QUIDEL MOLECULAR INFLUENZA A+B?

The FDA 510(k) record lists Quidel Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUIDEL MOLECULAR INFLUENZA A+B?

The FDA product code for QUIDEL MOLECULAR INFLUENZA A+B is OZE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Quidel Corp. as applicant

K131813QUIDEL MOLECULAR RSV + HMPV ASSAY K131728QUIDEL MOLECULAR INFLUENZA A + B ASSAY K130398SOFIA(R) RSV FIA K131166SOFIA(R) HCG FIA K131606SOFIA INFLUENZA A+B FIA K131619QUICKVUE INFLUENZA A+B

View all 93 devices →

Related Devices (Code: OZE)

K243274CDC 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)Centers for Disease Control and Prevention K243931CDC 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)Centers for Disease Control and Prevention K241110CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)Centers for Disease Control and Prevention K230236Lyra Influenza A+B AssayQuidel Corporation K220801ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2Abbott Diagnostics Scarborough, Inc.K200370CDC 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 KitCenters for Disease Control and Prevention

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.