Instrument for nucleic acid analysis - ANVISA Registration 10158120749
Access comprehensive regulatory information for Instrument for nucleic acid analysis in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 10158120749 and manufactured by BIOFIRE DIAGNOSTICS LLC. The registration is held by BIOMERIEUX BRASIL INDUSTRIA E COMERCIO DE PRODUTOS LABORATORIAIS 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 ROCHE MOLECULAR SYSTEMS, INC, QIAGEN GMBH, 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
Need help with your Brazil registration?
Contact Pure Global Brazil TeamDevice Details
Registration Details
10158120749
25351839683202333
33040635000171
Company Information
Dates and Status
Jan 02, 2024
VIGENTE
09/18/2025 19:00:01
Instrument for nucleic acid analysis
Biofire FilmArray 2.0
BIOFIRE DIAGNOSTICS LLC
10158120704
Feb 26, 2018
Instrument for nucleic acid analysis
Biofire FilmArray Torch
BIOFIRE DIAGNOSTICS LLC
10158120712
Oct 01, 2018
Instrument for nucleic acid analysis
HybriSpot12 PCR AUTO
VITRO S.A.
80502070076
Sep 16, 2019
Instrument for nucleic acid analysis
ID NOW Instrument
ABBOTT DIAGNOSTICS SCARBOROUGH, INC
10071770846
Apr 27, 2015
Instrument for nucleic acid analysis
Pyromark Q24
QIAGEN GMBH
10322259014
Dec 07, 2015
Instrumento para análise de ácidos nucleicos
CLEO™ Q16 PCR em Tempo Real
WIZBIOSOLUTIONS INC.
82202950028
Sep 15, 2025
Instrumento para análise de ácidos nucleicos
Sistema de Diagnóstico Molecular Totalmente Automático Molecision R8
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
80102513510
Sep 01, 2025
Instrumento para análise de ácidos nucleicos
SLAN- 96P Real-time PCR System
SHANGHAI HONGSHI MEDICAL TECHNOLOGY CO., LTD
80102513499
Aug 11, 2025
Instrumento para análise de ácidos nucleicos
Família DTprime II Real-time PCR instrument
DNA-TECHNOLOGY, RESEARCH & PRODUCTION
82149920129
Jul 14, 2025
Instrumento para análise de ácidos nucleicos
NextSeq 550Dx Instrument
ILLUMINA, INC.
80839210003
Jul 14, 2025