ANTIMITOCHONDRIAL ANTIBODY - ANVISA Registration 80003610581
Access comprehensive regulatory information for ANTIMITOCHONDRIAL 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 80003610581 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, PHADIA AB, 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
80003610581
25351286676202083
02004662000165
Company Information
Dates and Status
Aug 10, 2020
VIGENTE
09/18/2025 19:00:01
ANTIMITOCHONDRIAL ANTIBODY
QUANTA Lite™ M2 EP (MIT3) ELISA
INOVA DIAGNOSTICS, INC.
80003610227
Sep 24, 2009
AUTOIMMUNE HEPATITIS (AIH) ANTIBODY
Família QUANTA Flash LKM-1
INOVA DIAGNOSTICS, INC.
80003610580
Aug 10, 2020
ANTIMITOCHONDRIAL ANTIBODY
Família EliA M2 Positive Control
PHADIA AB
80254180309
Jul 16, 2018
ANTIMITOCHONDRIAL ANTIBODY
FAMÍLIA MAGLUMI® AMA-M2 IgG (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790432
Sep 16, 2024
ANTIMITOCHONDRIAL ANTIBODY
AMA-M2
ORGENTEC DIAGNOSTIKA GMBH
10300390657
May 20, 2019
ANTICORPO ANTIMITOCONDRIAL
AESKUSLIDES rLKS
AESKU DIAGNOSTICS GMBH & CO. KG
82910510001
Mar 05, 2025
ANTICORPO ANTIMITOCONDRIAL
FAMÍLIA MAGLUMI® AMA-M2 IgG (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790432
Sep 16, 2024
ANTICORPO ANTIMITOCONDRIAL
HepAK 7plus Dot
GA GENERIC ASSAYS GMBH
80464810897
Mar 04, 2024
ANTICORPO ANTIMITOCONDRIAL
MAGLUMI IgG Anti-M2-3E (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
80102512408
Mar 02, 2020
ANTICORPO ANTIMITOCONDRIAL
Myositis Plus
ORGENTEC DIAGNOSTIKA GMBH
10300390662
May 20, 2019