FDA 510(k)

Innovita Flu A/B Antigen Rapid Test

Número K: K250398 · 2025-07-03

RequerenteInnovita (Tangshan) Biological Technology Co., Ltd.

Data da decisão2025-07-03

Código do produtoPSZ

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

Innovita Flu A/B Antigen Rapid Test is the device name listed in this FDA 510(k) record. The listed applicant is Innovita (Tangshan) Biological Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-07-03 under 510(k) number K250398. 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 Innovita Flu A/B Antigen Rapid Test?

Innovita Flu A/B Antigen Rapid Test is a medical device that received FDA 510(k) clearance on 2025-07-03. The listed applicant is Innovita (Tangshan) Biological Technology Co., Ltd.. The 510(k) number is K250398.

When did Innovita Flu A/B Antigen Rapid Test receive FDA 510(k) clearance?

Innovita Flu A/B Antigen Rapid Test received FDA 510(k) clearance on 2025-07-03, under 510(k) number K250398.

Who is the listed applicant for Innovita Flu A/B Antigen Rapid Test?

The FDA 510(k) record lists Innovita (Tangshan) Biological Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Innovita Flu A/B Antigen Rapid Test?

The FDA product code for Innovita Flu A/B Antigen Rapid Test is PSZ.

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 Innovita (Tangshan) Biological Technology Co., Ltd. como candidato(a)

K241919Innovita HCG Pregnancy Rapid Combo Test K192843INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream

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 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 K223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitBd K192719Osom Ultra Plus Flu A&B Test KitSEKISUI Diagnostics, LLC

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.