FDA 510(k)

BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit

Número K: K223016 · 2023-01-27

RequerenteBd

Data da decisão2023-01-27

Código do produtoPSZ

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

BD VeritorTM 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 2023-01-27 under 510(k) number K223016. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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

BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit is a medical device that received FDA 510(k) clearance on 2023-01-27. The listed applicant is Bd. The 510(k) number is K223016.

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

BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit received FDA 510(k) clearance on 2023-01-27, under 510(k) number K223016.

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

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

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Outros registros que listam Bd como candidato(a)

K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)K240257Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit K232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit K221504BD Surgiphor™ Antimicrobial Irrigation System K180438BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit

Dispositivos Relacionados (Código: PSZ)

K254262Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAOrtho Clinical Diagnostics Inc. (QuidelOrtho)K252283Nano-Check Influenza A+B TestNano-Ditech Corporation K250398Innovita Flu A/B Antigen Rapid TestInnovita (Tangshan) Biological Technology Co., Ltd.K241188Acucy® Influenza A&B Test with the Acucy® 2 SystemSEKISUI Diagnostics, LLC K232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBd K192719Osom Ultra Plus Flu A&B Test KitSEKISUI Diagnostics, LLC

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