PHENYTOIN - CLASS II - ANVISA Registration 80146501914
Access comprehensive regulatory information for PHENYTOIN - CLASS II in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 80146501914 and manufactured by MICROGENICS CORPORATION. The registration is held by ABBOTT LABORATORIOS 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 ABBOTT LABORATORIES, SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD, 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
80146501914
25351713519201431
56998701000116
Company Information
Dates and Status
Feb 18, 2015
VIGENTE
09/18/2025 19:00:01
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II
Família de controles Antiepileptic Drugs
CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH
10350840388
Dec 17, 2020
CALIBRATORS AND MULTIPARAMETER STANDARDS OF ONE OR MORE CONCENTRATIONS - CLASS II
Serum Calibration Standard – Antiepileptic Drugs (AED)
CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH
10350840248
Apr 28, 2014
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II
ClinChek - Control Serum Control lyophilised ANTIEPILEPTICS 5
RECIPE CHEMICALS INSTRUMENTS GMBH
80464810659
May 06, 2019
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS III
Família Antiepileptic Drugs in serum/plasma
CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH
10350840480
Jun 30, 2025
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS III
Família Antiepileptic Drugs in serum/plasma
Not specified
10350840480
Jun 30, 2025
ABBOTT LABORATORIES• United States of America
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD• United Kingdom
ROCHE DIAGNOSTICS GMBH• Germany
SIEMENS HEALTHCARE DIAGNOSTICS, INC.• United States of America
SIEMENS HEALTHCARE DIAGNOSTICS INC.• United States of America
FENITOÍNA - CLASSE II
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ROCHE DIAGNOSTICS GMBH
10287411410
Jul 22, 2019
FENITOÍNA - CLASSE II
Alinity c Phenytoin Reagent Kit
B.R.A.H.M.S. GMBH
80146502172
Oct 29, 2018
FENITOÍNA - CLASSE II
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SIEMENS HEALTHCARE DIAGNOSTICS INC.
10345162144
Dec 18, 2017
FENITOÍNA - CLASSE II
ARCHITECT iPhenytoin Reagent Kit / ARCHITECT iFenitoína Kit Reagente
ABBOTT LABORATORIES
80146501716
Dec 07, 2010
FENITOÍNA - CLASSE II
ARCHITECT iPhenytoin Calibrators / ARCHITECT iFenitoína Calibradores
ABBOTT LABORATORIES
80146501688
Jul 26, 2010