FDA 510(k)

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

N.º K: K232434 · 2023-12-05

SolicitanteBd

Fecha de decisión2023-12-05

Código de productoPSZ

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Bd como solicitante

K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)K240257Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit K223016BD VeritorTM 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.K241188Prueba de Influenza A&B Acucy® con el Sistema Acucy® 2SEKISUI Diagnostics, LLC K223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitBd K192719Osom Ultra Plus Flu A&B Test KitSEKISUI Diagnostics, LLC

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.