ANTIPHOSPHOLIPID ANTIBODY - ANVISA Registration 80003610367
Access comprehensive regulatory information for ANTIPHOSPHOLIPID 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 80003610367 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.

Janaina dos Santos de Miranda
🇧🇷 Brazil Regulatory Expert
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Registration Details
80003610367
25351465375201365
02004662000165
Company Information
Dates and Status
Nov 04, 2013
VIGENTE
09/18/2025 19:00:01
ANTIPHOSPHOLIPID ANTIBODY
Quanta Flash® aCL IgA Controles
INOVA DIAGNOSTICS, INC
80003610511
Oct 05, 2015
ANTIPHOSPHOLIPID ANTIBODY
Quanta Flash® B2GP1 IgM Controles
INOVA DIAGNOSTICS, INC.
80003610429
Sep 22, 2014
ANTICARDIOLIPIN
Quanta Flash™ aCL IgG Controles
INOVA DIAGNOSTICS , INC.
80003610372
Mar 24, 2014
ANTIPHOSPHOLIPID ANTIBODY
Quanta Flash® ß2GP1 IgA Controles
INOVA DIAGNOSTICS, INC
80003610430
Sep 22, 2014
ANTIPHOSPHOLIPID ANTIBODY
Quanta Flash® B2GP1 IgG Controles
INOVA DIAGNOSTICS, INC.
80003610424
Sep 22, 2014
ANTICORPO ANTIFOSFOLIPÍDEOS
Família MAGLUMI® IgG anti-ß2-Glicoproteína 1 (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790437
Sep 16, 2024
ANTICORPO ANTIFOSFOLIPÍDEOS
Família MAGLUMI® IgM anti-ß2-Glicoproteína 1 (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790438
Sep 16, 2024
ANTICORPO ANTIFOSFOLIPÍDEOS
Família iFlash-B2-Glycoprotein I IgA
SHENZHEN YHLO BIOTECH CO., LTD
80867150151
Jul 10, 2023
ANTICORPO ANTIFOSFOLIPÍDEOS
Familia iFlash-B2-Glycoprotein I IgM
SHENZHEN YHLO BIOTECH CO., LTD
80867150153
Jul 10, 2023
ANTICORPO ANTIFOSFOLIPÍDEOS
Familia iFlash-B2-Glycoprotein I IgG
SHENZHEN YHLO BIOTECH CO., LTD
80867150154
Jul 10, 2023