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PBS (10X) BIOSYSTEMS BIOSIMEX - COFEPRIS Registration 1237R2021 SSA

Access comprehensive regulatory information for PBS (10X) BIOSYSTEMS BIOSIMEX (PBS (10X) BIOSYSTEMS BIOSIMEX) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1237R2021 SSA and manufactured by BIO SIMEX, S.A. DE C.V.. The device was registered on August 13, 2021.

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.

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COFEPRIS Official Data
Clase I
1237R2021 SSA
PBS (10X) BIOSYSTEMS BIOSIMEX
COFEPRIS Analysis ID: 1237R2021 SSA
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Product Use / Uso del Producto
Spanish

ELREACTIVOAUXILIARPBS(10X)BIOSYSTEMSBIOSIMEX SE UTILIZA PARA LADETERMINACIร“N CUALITATIVA DEANTICUERPOS ANTI-NUCLEARES (ANA) POREL Mร‰TODO DE INMUNOFLUORESCENCIAINDIRECTA. AGENTE DE DIAGNร“STICO INVITRO Y PARA USO EXCLUSIVO ENLABORATORIOS CLรNICOS O DE GABINETES

English

THE AUXILIARY REAGENT PBS(10X)BIOSYSTEMSBIOSIMEX IS USED FOR THE QUALITATIVE DETERMINATION OF ANTI-NUCLEAR ANTIBODIES (ANA) BY THE INDIRECT IMMUNOFLUORESCENCE METHOD. INVITRO DIAGNOSTIC AGENT AND FOR EXCLUSIVE USE IN CLINICAL OR CABINET LABORATORIES

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DE DIAGNร“STICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
REACTIVO AUXILIAR PBS (10X)
Trade Name (English)
AUXILIARY REAGENT PBS (10X)
Registration Information
Analysis ID
1237R2021 SSA
Registration Date
August 13, 2021
Manufacturer / Fabricante
Name (English)
BIO SIMEX, S.A. DE C.V.