Instrument intended for immunoassays - ANVISA Registration 80048490019
Access comprehensive regulatory information for Instrument intended for immunoassays in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 80048490019 and manufactured by MONOBIND, INC. The registration is held by USA DIAGNOSTICA 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 HANGZHOU ALLTEST BIOTECH CO. LTD, ACRO BIOTECH, INC. (MONTCLAIR), 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
80048490019
25351263979200670
02330159000108
Company Information
Dates and Status
Nov 13, 2006
VIGENTE
09/18/2025 19:00:01
Instrument intended for immunoassays
LEITORA DE ABSORBÂNCIA
BIOTEK INSTRUMENTS, INC
80313839003
Dec 08, 2014
Instrument intended for immunoassays
LEITOR GEENIUS
BIO-RAD
80020690321
Jun 10, 2014
Instrument intended for immunoassays
LEITORA DE REACOES DE AGLUTINACAO
DIAMED GMBH
80004040145
Jun 12, 2006
Instrument intended for immunoassays
LEITORA DE TIRAS LUMAX 4101 CLIA
MONOBIND, INC
80048490032
Mar 24, 2008
Instrument intended for immunoassays
LEITORA DE MICROPLACA
ROBONIK (INDIA) PVT LTD.
80915630014
Mar 12, 2018
HANGZHOU ALLTEST BIOTECH CO. LTD• China
ACRO BIOTECH, INC. (MONTCLAIR)• United States of America
DIAMED GMBH• Switzerland
SIEMENS HEALTHCARE DIAGNOSTICS INC.• United States of America
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD• China
Instrumento destinado a imunoensaios
HELIOS® AUTOMATED IFA SYSTEM
AESKU DIAGNOSTICS GMBH & CO. KG
82910510005
Sep 15, 2025
Instrumento destinado a imunoensaios
Fluorescent Immunoassay Analyzer
ZHUHAI KEYU BIOLOGICAL ENGINEERING CO., LTD.
81778810047
Sep 15, 2025
Instrumento destinado a imunoensaios
Familia de Analisadores Automáticos de Imunoensaio por Luminescência AutoLumo – Série S900
AUTOBIO LABTEC INSTRUMENTS CO., LTD
80102513511
Sep 01, 2025
Instrumento destinado a imunoensaios
Analisador de Imunoensaio por FluorescĂŞncia Luminis
QINGDAO HIGHTOP BIOTECH CO.,LTD.
80474870162
Aug 11, 2025
Instrumento destinado a imunoensaios
Vercentra CP-6
VIRTUE DIAGNOSTICS SUZHOU CO. LTD.
10009010497
Aug 11, 2025