ANTICYTOPLASMIC ANTIBODY - ANVISA Registration 80003610428
Access comprehensive regulatory information for ANTICYTOPLASMIC ANTIBODY in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 80003610428 and manufactured by INOVA DIAGNOSTICS, INC .. The registration is held by WERFEN MEDICAL LTDA with validity until currently active (VIGENTE).
This page provides complete technical specifications for this device, regulatory compliance details, 5 similar products found using AI-powered semantic search, 5 companies making the same product including ORGENTEC DIAGNOSTIKA GMBH, INOVA DIAGNOSTICS, INC., and 5 recent registrations in the same technical category. Pure Global AI offers free access to over 100,000+ Brazilian medical device registrations, helping global MedTech companies navigate ANVISA regulations, identify competitors, and discover partnership opportunities efficiently.

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Registration Details
80003610428
25351392855201428
02004662000165
Company Information
Dates and Status
Sep 22, 2014
VIGENTE
09/18/2025 19:00:01
ANTICYTOPLASMIC ANTIBODY
Quanta Flash® PR3
INOVA DIAGNOSTICS, INC .
80003610427
Sep 22, 2014
ANTICYTOPLASMIC ANTIBODY
Quanta Flash® PR3 Calibradores
INOVA DIAGNOSTICS, INC.
80003610434
Sep 22, 2014
ANTICYTOPLASMIC ANTIBODY
Quanta Flash® MPO Controles
INOVA DIAGNOSTICS, INC .
80003610426
Sep 22, 2014
ANTICYTOPLASMIC ANTIBODY
FAMÍLIA IFLASH-PR3 IGG E PR3 IGG CONTROL
SHENZHEN YHLO BIOTECH CO., LTD.
80867150106
Jul 15, 2021
ANTICYTOPLASMIC ANTIBODY
QUANTA Flash® CTD Screen Plus Calibradores
INOVA DIAGNOSTICS, INC.
80003610494
Apr 13, 2015
ORGENTEC DIAGNOSTIKA GMBH• Germany
INOVA DIAGNOSTICS, INC.• United States of America
IMMCO DIAGNOSTICS, INC.• United States of America
EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG• Germany
AESKU DIAGNOSTICS GMBH & CO. KG• Germany
ANTICORPO ANTICITOPLASMÁTICO
AESKUSLIDES ANCA Formalin
AESKU DIAGNOSTICS GMBH & CO. KG
82910510004
Jun 09, 2025
ANTICORPO ANTICITOPLASMÁTICO
AESKUSLIDES ANCA Ethanol
AESKU DIAGNOSTICS GMBH & CO. KG
82910510003
Apr 28, 2025
ANTICORPO ANTICITOPLASMÁTICO
Familia Maglumi MPO (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
80102513332
Dec 23, 2024
ANTICORPO ANTICITOPLASMÁTICO
Família MAGLUMI® IgG Anti-MPO (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790415
Aug 05, 2024
ANTICORPO ANTICITOPLASMÁTICO
Granulocyte Mosaic 25
EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG
10338930291
Sep 04, 2023