DIINSEL INFLUENZA A/B RAPIDTEST DEVICE - COFEPRIS Registration 376R2022 SSA
Access comprehensive regulatory information for DIINSEL INFLUENZA A/B RAPIDTEST DEVICE (DIINSEL INFLUENZA A/B RAPIDTEST DEVICE) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 376R2022 SSA and manufactured by DIINSEL, S.A. DE C.V.. The device was registered on May 13, 2022.
This page provides complete registration details including product type (III. DIAGNOSTIC AGENTS), manufacturer information, and regulatory compliance data from the official Mexico COFEPRIS medical device database. Pure Global AI offers free access to Mexico's complete medical device registry with bilingual Spanish/English support, helping global MedTech companies navigate COFEPRIS regulations efficiently.
ELDISPOSITIVODEPRUEBARÁPIDAINFLUENZAA/BESUNINMUNOENSAYOINVITROPARALADETECCIÓNDIRECTAYCUALITATIVADEANTÍGENOSNUCLEOPROTEICOSVIRALESDE INFLUENZA A Y B DE HISOPOSNASALES/NASOFARÍNGEOS Y LAVADOS/ASPIRADOSNASALESDEHUMANOS.SUOBJETIVOESAYUDARENELDIAGNÓSTICODIFERENCIALRÁPIDODELASINFECCIONESVIRALES POR INFLUENZA A Y B. EL EXÁMEN NO ESTÁDESTINADOALADETECCIÓNDEANTÍGENOSVIRALESDEINFLUENZA C.LOSRESULTADOSNEGATIVOSNOEXCLUYENLAS INFECCIONES VIRALES DE INFLUENZA
THE INFLUENZA RAPID TESTING DEVICE/BESUNIMMUNOASSAY INVITES DIRECT AND QUALITATIVE DETECTION OF INFLUENZA A AND B VIRAL NUCLEOPROTEIN ANTIGENS FROM NASAL/NASOPHARYNGEAL SWABS AND HUMAN NASAL LAVAGE/ASPIRATES. ITS OBJECTIVES ARE TO ASSIST IN THE RAPID DIFFERENTIAL DIAGNOSIS OF INFLUENZA A AND B VIRAL INFECTIONS. THE TEST IS NOT INTENDED FOR THE DETECTION OF INFLUENZA C VIRAL ANTIGENS. NEGATIVE RESULTS DO NOT EXCLUDE INFLUENZA VIRAL INFECTIONS