Materials for Endotoxin Detection - ANVISA Registration 80022060099
Access comprehensive regulatory information for Materials for Endotoxin Detection in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 80022060099 and manufactured by FUJIFILM WAKO CHEMICALS U.S.A. CORPORATION. The registration is held by FUJIFILM DO BRASIL 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 LONZA WALKERSVILLE, INC., FUJIFILM WAKO PURE CHEMICAL CORPORATION, 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
80022060099
25351223513201956
60397874000156
Company Information
Dates and Status
Jul 08, 2019
VIGENTE
09/18/2025 19:00:01
Materials for Endotoxin Detection
PYROSTAR™ ES-F Teste Unico Lisado com CSE Correspondente
FUJIFILM WAKO CHEMICALS U.S.A. CORPORATION
80022060101
Jul 08, 2019
Materials for Endotoxin Detection
PYROSTAR™ ES-F Multi Teste Lisado com CSE Correspondente
FUJIFILM WAKO CHEMICALS U.S.A. CORPORATION
80022060098
Jul 01, 2019
Materials for Endotoxin Detection
PYROSTAR™ ES-F Água Reagente LAL
FUJIFILM WAKO CHEMICALS U.S.A. CORPORATION
80022060100
Jul 08, 2019
Materials for Endotoxin Detection
PYROSTAR™ ES-F Lisado Bulk
FUJIFILM WAKO CHEMICALS U.S.A. CORPORATION
80022060097
Jul 01, 2019
Standards, Calibrators and Controls
CONTROLE PADRÃO DE ENDOTOXINA CPE
ASSOCIATES OF CAPE COD INCORPORATED
80313830010
Jul 23, 2012
LONZA WALKERSVILLE, INC.• United States of America
FUJIFILM WAKO PURE CHEMICAL CORPORATION• Japan
FUJIFILM WAKO CHEMICALS U.S.A. CORPORATION• United States of America
ASSOCIATES OF CAPE COD, INC• United States of America
CHARLES RIVER ENDOSAFE• United States of America
Materiais para Detecção de Endotoxinas
Reagente LAL recombinante PyroSmart NextGen
ASSOCIATES OF CAPE COD INC
80313830011
Dec 09, 2024
Materiais para Detecção de Endotoxinas
LAL - Kit de detecção de Endotoxinas
NOVA BIOTECNOLOGIA LTDA ME
81867919001
Mar 11, 2024
Materiais para Detecção de Endotoxinas
PYROSTAR Neo
FUJIFILM WAKO PURE CHEMICAL CORPORATION
80022069007
Jan 29, 2024
Materiais para Detecção de Endotoxinas
Limulus Color KY (Multi teste)
FUJIFILM WAKO PURE CHEMICAL CORPORATION
80022069005
Jan 29, 2024
Materiais para Detecção de Endotoxinas
Limulus Color KY (Teste Único)
FUJIFILM WAKO PURE CHEMICAL CORPORATION
80022069006
Jan 29, 2024