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This comprehensive analysis showcases immunology and microbiology medical devices registered with Brazil's ANVISA, powered by AI semantic search across 100,000+ products. Immunology and microbiology devices include immunoassay systems, microbial identification platforms, culture media and systems, serology analyzers, molecular diagnostics, infectious disease testing equipment, rapid test kits, and laboratory automation essential for diagnosing infections, monitoring immune responses, and ensuring patient safety.

Our AI analysis identified 3,970 immunology/microbiology device registrations from 622 global manufacturers held by 245 registration holders in Brazil. The rankings below reveal market leaders, emerging players, quarterly registration trends, most common product types, and recent ANVISA approvals—providing actionable competitive intelligence for manufacturers, distributors, and regulatory professionals targeting Brazil's immunology and microbiology market.

Understanding the immunology and microbiology device landscape in Brazil helps companies identify partnership opportunities, benchmark market positioning, assess competitive dynamics, and develop market entry strategies. Pure Global AI's semantic search technology categorizes devices by medical specialty automatically, delivering specialized market intelligence completely free.

Immunology / Microbiology Medical Devices

AI-powered insights on immunology / microbiology devices registered with Brazil ANVISA

3,970
Total Devices
622
Manufacturers
245
Reg. Holders
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Registration Trends
Quarterly activity (last 4 years)
Q4'21
64
Q1'22
42
Q2'22
37
Q3'22
48
Q4'22
97
Q1'23
123
Q2'23
74
Q3'23
88
Q4'23
60
Q1'24
60
Q2'24
33
Q3'24
83
Q4'24
83
Q1'25
107
Q2'25
89
Q3'25
89
Recent Registrations
Latest 10 immunology / microbiology device registrations

ORTHOPOXVIRUS

Class III
Sep 15, 2025

Monkeypox Virus Detection Kit (Fluorescence PCR)

Mfr: N/AHolder: Enzytec Biotecnologia Ltda.

ORTHOPOXVIRUS

Class III
Sep 15, 2025

Monkeypox Virus Detection Kit (Fluorescence PCR)

Mfr: ZHEJIANG ORIENT GENE BIOTECH CO., LTD.Holder: Enzytec Biotecnologia Ltda.

HEPATITIS A VIRUS (HAV)

Class III
Sep 15, 2025

Anti-HAV IgM Reagent Kit

Mfr: LABTEST DIAGNOSTICA S/AHolder: LABTEST DIAGNOSTICA S/A

Instrument intended for immunoassays

Class II
Sep 15, 2025

HELIOS® AUTOMATED IFA SYSTEM

Mfr: AESKU DIAGNOSTICS GMBH & CO. KGHolder: NACH BRASIL PRODUTOS DIAGNOSTICOS LTDA

MYCOBACTERIUM

Class III
Sep 15, 2025

RIDA® TB Tubes

Mfr: R-BIOPHARM AGHolder: R-BIOPHARM BRASIL COMERCIO DE PRODUTOS PARA ANALISE DE ALIMENTOS LTDA

MYCOBACTERIUM

Class III
Sep 15, 2025

RIDA® TB Tubes

Mfr: N/AHolder: R-BIOPHARM BRASIL COMERCIO DE PRODUTOS PARA ANALISE DE ALIMENTOS LTDA

TOTAL ANTIBODY TO HEPATITIS B VIRUS S ANTIGEN (ANTI-HBSAG)

Class IV
Sep 15, 2025

FASTLINE HBsAb

Mfr: KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDAHolder: KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA

CALPROTECTIN

Class II
Sep 15, 2025

Calprotectin Quality Control (Quantitative)

Mfr: ZHUHAI KEYU BIOLOGICAL ENGINEERING CO., LTD.Holder: LATIN HEALTH IMPORTADORA E DISTRIBUIDORA LTDA.

CULTURE MEDIA AND DEVICES FOR ANTIMICROBIAL SUSCEPTIBILITY TESTING

Class II
Sep 15, 2025

Cartão de antibiograma Reny DL-120 E - AST (BrCast)

Mfr: ZHUHAI DL BIOTECH CO., LTDHolder: RENYLAB QUÍMICA E FARMACÊUTICA LTDA

DENGUE

Class III
Sep 15, 2025

Artron Dengue NS1 Antigen Test

Mfr: ARTRON LABORATORIES INC.Holder: GENESTAR INOVAÇÕES E EQUIPAMENTOS MÉDICOS LTDA
Risk Class Distribution
Distribution by ANVISA risk classification
244
Class I
1,754
Class II
1,184
Class III
788
Class IV