ANTIPHOSPHOLIPID ANTIBODY - ANVISA Registration 80003610510
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 80003610510 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
80003610510
25351297947201551
02004662000165
Company Information
Dates and Status
Jul 20, 2015
VIGENTE
09/18/2025 19:00:01
ANTIPHOSPHOLIPID ANTIBODY
QUANTA Lite® aPS/PT IgM ELISA
INOVA DIAGNOSTICS, INC.
80003610509
Jul 13, 2015
ANTIPHOSPHOLIPID ANTIBODY
Quanta Flash® Beta2GPI IgG
INOVA DIAGNOSTICS, INC.
80003610471
Feb 18, 2015
ANTIPHOSPHOLIPID ANTIBODY
Anti-Fosfatidil Serina IgG
ORGENTEC DIAGNOSTIKA GMBH
10300390670
May 20, 2019
ANTIPHOSPHOLIPID ANTIBODY
Corgenix Anti-Phosphatidylserine IgG Semi-Quantitative Test Kit
CORGENIX, INC
10230730159
Apr 20, 2022
ANTIPHOSPHOLIPID ANTIBODY
QUANTA Flash® ß2GP1-Domain1
INOVA DIAGNOSTICS, INC
80003610455
Dec 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