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FDA 510(k)

QUICKVUE INFLUENZA A+B

K-Number: K131619 · 2013-06-28

ApplicantQuidel Corp.
Decision Date2013-06-28
Product CodeGNX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUICKVUE 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 2013-06-28 under 510(k) number K131619. The device is classified under product code GNX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUICKVUE INFLUENZA A+B?

QUICKVUE INFLUENZA A+B is a medical device that received FDA 510(k) clearance on 2013-06-28. The listed applicant is Quidel Corp.. The 510(k) number is K131619.

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

QUICKVUE INFLUENZA A+B received FDA 510(k) clearance on 2013-06-28, under 510(k) number K131619.

Who is the listed applicant for QUICKVUE 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 QUICKVUE INFLUENZA A+B?

The FDA product code for QUICKVUE INFLUENZA A+B is GNX.

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Other records listing Quidel Corp. as applicant

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.

K131813QUIDEL MOLECULAR RSV + HMPV ASSAYK131728QUIDEL MOLECULAR INFLUENZA A + B ASSAYK130398SOFIA(R) RSV FIAK131166SOFIA(R) HCG FIAK131606SOFIA INFLUENZA A+B FIAK122189QUIDEL MOLECULAR RSV + HMPV ASSAY

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Related Devices (Code: GNX)

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.

K133411ALERE BINAXNOW INFLUENZA A & B CARDAlere Scarborough, Inc D/B/A Binax, Inc.K132352SAS FLUALERT A & B, SAS INFLUENZA A TESTSa Scientific , Ltd.K131804REMEL XPECT FLU A&BRemel, Inc.K131606SOFIA INFLUENZA A+B FIAQuidel Corp.K131599QUICK VUE INFLUENZAQuidel CorporationK123182OSOM INFLUENZA A&B TEST MODEL 190SEKISUI Diagnostics, LLC

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.

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