M-PIMA™ HIV-1/2 DETECT - COFEPRIS Registration 657R2022 SSA
Access comprehensive regulatory information for M-PIMA™ HIV-1/2 DETECT (M-PIMA™ HIV-1/2 DETECT) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 657R2022 SSA and manufactured by ABBOTTLABORATORIES DEMÉXICO, S.A. DE C.V.. The device was registered on July 22, 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.
M-PIMA™ HIV-1/2 DETECT ES UN TEST CUALITATIVO DEAMPLIFICACIÓN DE ÁCIDOS NUCLEICOS PARA LADETECCIÓNDEARNDELVIRUSDE INMUNODEFICIENCIAHUMANA (VIH) TIPO 1 GRUPOS M/N Y O, Y TIPO 2 ENMUESTRASDESANGRECOMPLETAYPLASMAHUMANOS.PARAUSOENLABORATORIOYENTORNOSEXTERNOS.NOESTÁ INDICADO PARA SER USADO COMO PRUEBA DEEXPLORACIÓN DE DONANTES PARA VIH. AGENTE DEDIAGNÓSTICOPARAUSOINVITRO.PARAUSOEXCLUSIVODELABORATORIOS CLÍNICOS Y DE GABINETES.
M-PIMA™ HIV-1/2 DETECT IS A QUALITATIVE NUCLEIC ACID AMPLIFICATION TEST FOR THE DETECTION OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) TYPE 1 GROUPS M/N AND O, AND TYPE 2 IN HUMAN WHOLE BLOOD AND PLASMA SAMPLES. FOR use in laboratories and external environments. IT IS NOT INDICATED FOR USE AS A DONOR SCREENING TEST FOR HIV. DIAGNOSTIC AGENT for use in the hospital. FOR THE EXCLUSIVE USE OF CLINICAL LABORATORIES AND CABINETS.