Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

PMA de la FDA

Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors

Número de PMA: P190033 · 2024-10-04

SolicitanteARUP Laboratories
Fecha de decisión2024-10-04
Número PMAP190033
Código de productoQWQ
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorHE

Resumen del dispositivo

Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors is the device name listed in this FDA 510(k) record. The listed applicant is ARUP Laboratories. It received FDA 510(k) clearance on 2024-10-04. The device is classified under product code QWQ. It was reviewed by the HE advisory panel.

Preguntas frecuentes

What is the Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors?

Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors is a medical device that received FDA 510(k) clearance on 2024-10-04. The listed applicant is ARUP Laboratories.

When did Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors receive FDA 510(k) clearance?

The clearance date for Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors can be found in the official FDA records.

Who is the listed applicant for Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors?

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

What is the FDA product code for Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors?

The FDA product code for Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors is QWQ.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

↑