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FDA 510(k)

BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit

K-Number: K232434 · 2023-12-05

ApplicantBd
Decision Date2023-12-05
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit is the device name listed in this FDA 510(k) record. The listed applicant is Bd. It received FDA 510(k) clearance on 2023-12-05 under 510(k) number K232434. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit?

BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit is a medical device that received FDA 510(k) clearance on 2023-12-05. The listed applicant is Bd. The 510(k) number is K232434.

When did BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit receive FDA 510(k) clearance?

BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit received FDA 510(k) clearance on 2023-12-05, under 510(k) number K232434.

Who is the listed applicant for BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit?

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

What is the FDA product code for BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit?

The FDA product code for BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit is PSZ.

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.

NCT05765396SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies (Level42)COMPLETED

Other records listing Bd 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.

K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)K240257Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery KitK223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitK221504BD Surgiphor™ Antimicrobial Irrigation SystemK180438BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit

Related Devices (Code: PSZ)

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.

K252283Nano-Check Influenza A+B TestNano-Ditech CorporationK250398Innovita Flu A/B Antigen Rapid TestInnovita (Tangshan) Biological Technology Co., Ltd.K241188Acucy® Influenza A&B Test with the Acucy® 2 SystemSEKISUI Diagnostics, LLCK223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitBdK192719Osom Ultra Plus Flu A&B Test KitSEKISUI Diagnostics, LLCK191514CareStart Flu A&B PlusAccess Bio, 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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