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FDA 510(k)

QUIDEL MOLECULAR RSV + HMPV ASSAY

K-Number: K131813 · 2013-09-06

ApplicantQuidel Corp.
Decision Date2013-09-06
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUIDEL MOLECULAR RSV + HMPV ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 2013-09-06 under 510(k) number K131813. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUIDEL MOLECULAR RSV + HMPV ASSAY?

QUIDEL MOLECULAR RSV + HMPV ASSAY is a medical device that received FDA 510(k) clearance on 2013-09-06. The listed applicant is Quidel Corp.. The 510(k) number is K131813.

When did QUIDEL MOLECULAR RSV + HMPV ASSAY receive FDA 510(k) clearance?

QUIDEL MOLECULAR RSV + HMPV ASSAY received FDA 510(k) clearance on 2013-09-06, under 510(k) number K131813.

Who is the listed applicant for QUIDEL MOLECULAR RSV + HMPV ASSAY?

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 RSV + HMPV ASSAY?

The FDA product code for QUIDEL MOLECULAR RSV + HMPV ASSAY is OCC.

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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.

K131728QUIDEL MOLECULAR INFLUENZA A + B ASSAYK130398SOFIA(R) RSV FIAK131166SOFIA(R) HCG FIAK131606SOFIA INFLUENZA A+B FIAK131619QUICKVUE INFLUENZA A+BK122189QUIDEL MOLECULAR RSV + HMPV ASSAY

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Related Devices (Code: OCC)

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.

K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.K254139BioCode® Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.K242613NxTAG® Respiratory Pathogen PanelLuminex Molecular Diagnostics, Inc.K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc.K213822cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.

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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