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D-10TM HEMOGLOBIN A1C PROGRAM - COFEPRIS Registration 898R2019 SSA

Access comprehensive regulatory information for D-10TM HEMOGLOBIN A1C PROGRAM (D-10TM HEMOGLOBIN A1C PROGRAM) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 898R2019 SSA and manufactured by BIO-RAD, S.A.. The device was registered on May 02, 2019.

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 II
898R2019 SSA
D-10TM HEMOGLOBIN A1C PROGRAM
COFEPRIS Analysis ID: 898R2019 SSA
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Product Use / Uso del Producto
Spanish

EL D-10TM HEMOGLOBIN A1C PROGRAM HA SIDO DISEร‘ADO PARA LA DETERMINACIร“N CUANTITATIVA DE LOS NIVELES DE HEMOGLOBINA A1C (MMOL/MOL DE IFCC Y % DE NGSP) EN SANGRE HUMANA UTILIZANDO LA CROMATOGRAFรA LรQUIDA DE ALTA RESOLUCIร“N (HPLC) POR INTERCAMBIO Iร“NICO EN

English

THE D-10TM HEMOGLOBIN A1C PROGRAM HAS BEEN DESIGNED FOR THE QUANTITATIVE DETERMINATION OF HEMOGLOBIN A1C LEVELS (IFCC MMOL/MOL AND NGSP% %) IN HUMAN BLOOD USING ION EXCHANGE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) IN

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
III. AGENTES DE DIAGNร“STICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
KIT PARA LA DETERMINACIร“N CUANTITATIVA DE HEMOGLOBINA A1C EN SANGRE HUMANA
Trade Name (English)
KIT FOR THE QUANTITATIVE DETERMINATION OF HEMOGLOBIN A1C IN HUMAN BLOOD
Registration Information
Analysis ID
898R2019 SSA
Registration Date
May 02, 2019
Manufacturer / Fabricante
Name (Spanish)
BIO-RAD, S.A.
Name (English)
BIO-RAD, S.A.