FDA 510(k)

cobas® BV/CV

Número K: K260021 · 2026-07-16

Data da decisão2026-07-16

Código do produtoPQA

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

cobas® BV/CV is the device name listed in this FDA 510(k) record. The listed applicant is Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2026-07-16 under 510(k) number K260021. The device is classified under product code PQA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the cobas® BV/CV?

cobas® BV/CV is a medical device that received FDA 510(k) clearance on 2026-07-16. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K260021.

When did cobas® BV/CV receive FDA 510(k) clearance?

cobas® BV/CV received FDA 510(k) clearance on 2026-07-16, under 510(k) number K260021.

Who is the listed applicant for cobas® BV/CV?

The FDA 510(k) record lists Roche Molecular Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for cobas® BV/CV?

The FDA product code for cobas® BV/CV is PQA.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

Outros registros que listam Roche Molecular Systems, Inc. como candidato(a)

K260045cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190)K260047cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)K260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems K253756cobas liat CT/NG nucleic acid test K253759cobas liat CT/NG/MG nucleic acid test K243753cobas liat Bordetella panel nucleic acid test

Ver todos os 36 dispositivos →

Dispositivos Relacionados (Código: PQA)

K243725BD Vaginal PanelBecton, Dickinson and Company K243345Aptima BV Assay; Aptima CV/TV AssayHologic, Inc.K231381Xpert Xpress MVP; GeneXpert Xpress SystemCepheid K223653BD Vaginal PanelBecton, Dickinson and Company K221160Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid K212213Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.