ANTICARDIOLIPIN - ANVISA Registration 80003610326
Access comprehensive regulatory information for ANTICARDIOLIPIN in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 80003610326 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
80003610326
25351034275201352
02004662000165
Company Information
Dates and Status
Mar 25, 2013
VIGENTE
09/18/2025 19:00:01
ANTICARDIOLIPIN
QUANTA Lite ACA IgG III
INOVA DIAGNOSTICS , INC.
80003610230
Sep 24, 2009
ANTICARDIOLIPIN
QUANTA Lite ACA IgA III
INOVA DIAGNOSTICS , INC.
80003610327
Mar 25, 2013
ANTICARDIOLIPIN
QUANTA Lite ACA IgM III
INOVA DIAGNOSTICS, INC.
80003610382
Jun 10, 2014
ANTICARDIOLIPIN
Anti-Cardiolipin Screen
ORGENTEC DIAGNOSTIKA GMBH
80416660115
Jan 09, 2023
ANTICARDIOLIPIN
Anti-Cardiolipin Screen
ORGENTC DIAGNOSTICA CMBH
10300390482
May 20, 2019
ANTICARDIOLIPINA
Família MAGLUMI® IgM Anticardiolipina (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790422
Aug 26, 2024
ANTICARDIOLIPINA
Família MAGLUMI® IgG Anticardiolipina
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790387
Jan 29, 2024
ANTICARDIOLIPINA
Familia iFlash-Cardiolipin IgM
SHENZHEN YHLO BIOTECH CO., LTD
80867150150
Jul 10, 2023
ANTICARDIOLIPINA
Família iFlash Cardiolipin IgG
SHENZHEN YHLO BIOTECH CO., LTD
80867150152
Jul 10, 2023
ANTICARDIOLIPINA
Familia iFlash Cardiolipin IgA
SHENZHEN YHLO BIOTECH CO., LTD
80867150148
Jul 03, 2023