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

Assay, enzyme linked immunosorbent, hepatitis c virus

Número de PMA: P010021 · 2020-08-07

SolicitanteOrtho-Clinical Diagnostics, Inc.
Fecha de decisión2020-08-07
Número PMAP010021
Código de productoMZO
Clase del dispositivoClase 2
Especialidad médicaM
Número de regulación21 CFR 8
Comité asesorMI

Resumen del dispositivo

Assay, enzyme linked immunosorbent, hepatitis c virus is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-08-07. The device is classified under product code MZO. It was reviewed by the MI advisory panel.

Preguntas frecuentes

What is the Assay, enzyme linked immunosorbent, hepatitis c virus?

Assay, enzyme linked immunosorbent, hepatitis c virus is a medical device that received FDA 510(k) clearance on 2020-08-07. The listed applicant is Ortho-Clinical Diagnostics, Inc..

When did Assay, enzyme linked immunosorbent, hepatitis c virus receive FDA 510(k) clearance?

The clearance date for Assay, enzyme linked immunosorbent, hepatitis c virus can be found in the official FDA records.

Who is the listed applicant for Assay, enzyme linked immunosorbent, hepatitis c virus?

The FDA 510(k) record lists Ortho-Clinical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Assay, enzyme linked immunosorbent, hepatitis c virus?

The FDA product code for Assay, enzyme linked immunosorbent, hepatitis c virus is MZO.

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.

↑