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FDA 510(k)

BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System

K-Number: K230956 · 2023-07-31

ApplicantBd Integrated Diagnostic Solutions /
Decision Date2023-07-31
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System is the device name listed in this FDA 510(k) record. The listed applicant is Bd Integrated Diagnostic Solutions /. It received FDA 510(k) clearance on 2023-07-31 under 510(k) number K230956. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System?

BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System is a medical device that received FDA 510(k) clearance on 2023-07-31. The listed applicant is Bd Integrated Diagnostic Solutions /. The 510(k) number is K230956.

When did BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System receive FDA 510(k) clearance?

BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System received FDA 510(k) clearance on 2023-07-31, under 510(k) number K230956.

Who is the listed applicant for BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System?

The FDA 510(k) record lists Bd Integrated Diagnostic Solutions / as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System?

The FDA product code for BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System is QOF.

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.

NCT07631377The LalelaLung Study: Digital Stethoscope Clinical EvaluationNOT_YET_RECRUITING

Related Devices (Code: QOF)

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.

K252932Fast PCR Mini Respiratory PanelAutonomous Medical Devices IncorporatedK252269FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.K251742VELO Respiratory TestLex Diagnostics LimitedK251978LIAISON NES FLU A/B, RSV & COVID-19Diasorin Molecular, LLCK252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)Diasorin Molecular, LLCK250080QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel MiniQIAGEN GmbH

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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