Manufacturer profile

ORTHO CLINICAL DIAGNOSTICS

BrazilUnited Kingdom70 ANVISA registrations52 unique technical categoriesJul 28, 1997 – May 11, 2026

Verified

Total products

Technical names

Jul 1997

Earliest registration

May 2026

Latest registration

Regulatory footprint

Search ORTHO CLINICAL DIAGNOSTICS across other regulatory registries

Recent registrations

Latest 5 products registered by this manufacturer

TREPONEMA PALLIDUM

Família VITROS Immunodiagnostic Products Syphilis TPA Reagent Pack, Calibrator and Control

Class IV · May 11, 2026

PROSTATE SPECIFIC ANTIGEN (PSA) FREE

Família VITROS Immunodiagnostic Products Free PSA Reagent Pack and Calibrator

Class III · May 04, 2026

RUBELLA VIRUS

Família VITROS Immunodiagnostic Products Rubella IgM Reagent Pack and Calibrator

Class III · Apr 22, 2026

PROSTATE-SPECIFIC ANTIGEN (PSA)

Família VITROS Immunodiagnostic Products Total PSA II Reagent Pack and Calibrator

Class III · Apr 22, 2026

IMMUNOHEMATOLOGY - RARE SERA FOR COLUMN TECHNOLOGY

Famíla Ortho BioVue® System - Rh/K Cassette

Class III · Oct 06, 2025

Most popular products

Products with most registrations

ANTI-HUMAN GLOBULIN (COOMBS)

5 registrations

Instrument intended for immunoassays

3 registrations

RUBELLA VIRUS

2 registrations

TAMPÕES, DILUENTES E DEMAIS SOLUÇÕES PARA ANÁLISE LABORATORIAL

2 registrations

HERPES VIRUS (HHV 5) - CYTOMEGALOVIRUS

2 registrations

Top registration holders

Companies holding product registrations for this manufacturer

ORTHO CLINICAL DIAGNÓSTICS DO BRASIL PRODUTOS PARA SAÚDE LTDA

69 products

REM INDUSTRIA E COMERCIO LTDA

1 products

Top competitors

Companies with the most overlapping products (same technical names)

ROCHE DIAGNOSTICS GMBH

Germany

232 registrations43 shared products

Shared products: ALPHAFETOPROTEIN (AFP), C-PEPTIDE, CA 125 ANTIGEN, CA 15-3 ANTIGEN, CA 19-9 ANTIGEN, CARCINOEMBRYONIC ANTIGEN, COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II, CORONAVIRUS, CORTISOL/CORTISONE, CREATINE KINASE ISOENZYMES (CKMB, CKBB, CKMM), ESTRADIOL, FOLLICLE STIMULATING HORMONE (FSH), HEPATITIS A VIRUS (HAV), HEPATITIS B VIRUS E ANTIGEN (HBEAG), HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG), HEPATITIS B VIRUS SURFACE CONFIRMATORY ANTIGEN (HBSAG), HERPES VIRUS (HHV 5) - CYTOMEGALOVIRUS, HUMAN BRAIN NATRIURETIC PEPTIDE (BNP), INTACT PARATHYROID HORMONE (iPTH), Instrument for analysis of general biochemistry, hormones, drugs or proteins, Instrument intended for immunoassays, Instrumento para preparo e processamento de amostras fase pré-analítica, MYOGLOBIN, NUCLEAR IMMUNOGLOBULIN M FOR HEPATITIS B VIRUS (ANTI-HBC IGM), PROCALCITONIN PCT, PROGESTERONE, PROLACTIN, PROSTATE SPECIFIC ANTIGEN (PSA) FREE, PROSTATE-SPECIFIC ANTIGEN (PSA), RUBELLA VIRUS, TAMPÕES, DILUENTES E DEMAIS SOLUÇÕES PARA ANÁLISE LABORATORIAL, TESTOSTERONE, THYROID STIMULATING HORMONE (TSH), THYROXINE (T4), TOTAL ANTIBODY FOR HEPATITIS B VIRUS E ANTIGEN (ANTI-HBEAG), TOTAL ANTIBODY TO HEPATITIS B VIRUS S ANTIGEN (ANTI-HBSAG), TOTAL ANTIBODY TO HEPATITIS C VIRUS (ANTI-HCV), TOTAL NUCLEAR ANTIBODY FOR HEPATITIS B VIRUS (ANTI-HBCAG), TOXOPLASMA GONDII, TREPONEMA PALLIDUM, TRIIODOTHYRONINE (T3), TRYPANOSOMA CRUZI, VITAMIN B12 (FOLIC ACID)

SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.

China

86 registrations43 shared products

Shared products: 25 HYDROXYVITAMIN D3 OF VITAMIN D, ALPHAFETOPROTEIN (AFP), C-PEPTIDE, CA 125 ANTIGEN, CA 15-3 ANTIGEN, CA 19-9 ANTIGEN, CARCINOEMBRYONIC ANTIGEN, COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II, CORONAVIRUS, CORTISOL/CORTISONE, CREATINE KINASE ISOENZYMES (CKMB, CKBB, CKMM), ESTRADIOL, FOLLICLE STIMULATING HORMONE (FSH), HEPATITIS A VIRUS (HAV), HEPATITIS B VIRUS E ANTIGEN (HBEAG), HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG), HERPES VIRUS (HHV 5) - CYTOMEGALOVIRUS, HUMAN BRAIN NATRIURETIC PEPTIDE (BNP), INTACT PARATHYROID HORMONE (iPTH), Instrument for analysis of general biochemistry, hormones, drugs or proteins, Instrument intended for immunoassays, Instrumento para preparo e processamento de amostras fase pré-analítica, MYOGLOBIN, NUCLEAR IMMUNOGLOBULIN M FOR HEPATITIS B VIRUS (ANTI-HBC IGM), PROCALCITONIN PCT, PROGESTERONE, PROLACTIN, PROSTATE SPECIFIC ANTIGEN (PSA) FREE, PROSTATE-SPECIFIC ANTIGEN (PSA), RUBELLA VIRUS, TAMPÕES, DILUENTES E DEMAIS SOLUÇÕES PARA ANÁLISE LABORATORIAL, TESTOSTERONE, THYROID STIMULATING HORMONE (TSH), THYROXINE (T4), TOTAL ANTIBODY FOR HEPATITIS B VIRUS E ANTIGEN (ANTI-HBEAG), TOTAL ANTIBODY TO HEPATITIS B VIRUS S ANTIGEN (ANTI-HBSAG), TOTAL ANTIBODY TO HEPATITIS C VIRUS (ANTI-HCV), TOTAL NUCLEAR ANTIBODY FOR HEPATITIS B VIRUS (ANTI-HBCAG), TOXOPLASMA GONDII, TREPONEMA PALLIDUM, TRIIODOTHYRONINE (T3), TRYPANOSOMA CRUZI, VITAMIN B12 (FOLIC ACID)

SIEMENS HEALTHCARE DIAGNOSTICS INC.

United States

175 registrations40 shared products

Shared products: ALPHAFETOPROTEIN (AFP), C-PEPTIDE, CA 125 ANTIGEN, CA 15-3 ANTIGEN, CA 19-9 ANTIGEN, CARCINOEMBRYONIC ANTIGEN, COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II, CORTISOL/CORTISONE, CREATINE KINASE ISOENZYMES (CKMB, CKBB, CKMM), ESTRADIOL, FOLLICLE STIMULATING HORMONE (FSH), HEPATITIS A VIRUS (HAV), HEPATITIS B VIRUS E ANTIGEN (HBEAG), HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG), HEPATITIS B VIRUS SURFACE CONFIRMATORY ANTIGEN (HBSAG), HERPES VIRUS (HHV 5) - CYTOMEGALOVIRUS, HUMAN BRAIN NATRIURETIC PEPTIDE (BNP), INTACT PARATHYROID HORMONE (iPTH), Instrument for analysis of general biochemistry, hormones, drugs or proteins, Instrument intended for immunoassays, Instrumento para preparo e processamento de amostras fase pré-analítica, MYOGLOBIN, NUCLEAR IMMUNOGLOBULIN M FOR HEPATITIS B VIRUS (ANTI-HBC IGM), PROGESTERONE, PROLACTIN, PROSTATE SPECIFIC ANTIGEN (PSA) FREE, PROSTATE-SPECIFIC ANTIGEN (PSA), RUBELLA VIRUS, TAMPÕES, DILUENTES E DEMAIS SOLUÇÕES PARA ANÁLISE LABORATORIAL, TESTOSTERONE, THYROID STIMULATING HORMONE (TSH), THYROXINE (T4), TOTAL ANTIBODY FOR HEPATITIS B VIRUS E ANTIGEN (ANTI-HBEAG), TOTAL ANTIBODY TO HEPATITIS B VIRUS S ANTIGEN (ANTI-HBSAG), TOTAL ANTIBODY TO HEPATITIS C VIRUS (ANTI-HCV), TOTAL NUCLEAR ANTIBODY FOR HEPATITIS B VIRUS (ANTI-HBCAG), TOXOPLASMA GONDII, TREPONEMA PALLIDUM, TRIIODOTHYRONINE (T3), VITAMIN B12 (FOLIC ACID)

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

China

150 registrations36 shared products

Shared products: 25 HYDROXYVITAMIN D3 OF VITAMIN D, ALPHAFETOPROTEIN (AFP), C-PEPTIDE, CA 125 ANTIGEN, CA 15-3 ANTIGEN, CA 19-9 ANTIGEN, CARCINOEMBRYONIC ANTIGEN, COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II, CORTISOL/CORTISONE, CREATINE KINASE ISOENZYMES (CKMB, CKBB, CKMM), ESTRADIOL, FOLLICLE STIMULATING HORMONE (FSH), HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG), HERPES VIRUS (HHV 5) - CYTOMEGALOVIRUS, HUMAN BRAIN NATRIURETIC PEPTIDE (BNP), INTACT PARATHYROID HORMONE (iPTH), Instrument for analysis of general biochemistry, hormones, drugs or proteins, Instrument intended for immunoassays, Instrumento para preparo e processamento de amostras fase pré-analítica, MYOGLOBIN, PROGESTERONE, PROLACTIN, PROSTATE SPECIFIC ANTIGEN (PSA) FREE, PROSTATE-SPECIFIC ANTIGEN (PSA), RUBELLA VIRUS, TAMPÕES, DILUENTES E DEMAIS SOLUÇÕES PARA ANÁLISE LABORATORIAL, TESTOSTERONE, THYROID STIMULATING HORMONE (TSH), THYROXINE (T4), TOTAL ANTIBODY FOR HEPATITIS B VIRUS E ANTIGEN (ANTI-HBEAG), TOTAL ANTIBODY TO HEPATITIS B VIRUS S ANTIGEN (ANTI-HBSAG), TOTAL ANTIBODY TO HEPATITIS C VIRUS (ANTI-HCV), TOXOPLASMA GONDII, TREPONEMA PALLIDUM, TRIIODOTHYRONINE (T3), VITAMIN B12 (FOLIC ACID)

LABTEST DIAGNOSTICA S/A

Brazil

75 registrations35 shared products

Shared products: ALPHAFETOPROTEIN (AFP), ANTIBODY FOR HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 AND TYPE 2 (HIV 1 AND HIV 2), C-PEPTIDE, CA 125 ANTIGEN, CA 15-3 ANTIGEN, CA 19-9 ANTIGEN, CARCINOEMBRYONIC ANTIGEN, COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II, CORONAVIRUS, CORTISOL/CORTISONE, CREATINE KINASE ISOENZYMES (CKMB, CKBB, CKMM), ESTRADIOL, FOLLICLE STIMULATING HORMONE (FSH), HEPATITIS A VIRUS (HAV), HEPATITIS B VIRUS E ANTIGEN (HBEAG), HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG), HERPES VIRUS (HHV 5) - CYTOMEGALOVIRUS, NUCLEAR IMMUNOGLOBULIN M FOR HEPATITIS B VIRUS (ANTI-HBC IGM), PROCALCITONIN PCT, PROGESTERONE, PROLACTIN, PROSTATE SPECIFIC ANTIGEN (PSA) FREE, PROSTATE-SPECIFIC ANTIGEN (PSA), RUBELLA VIRUS, TAMPÕES, DILUENTES E DEMAIS SOLUÇÕES PARA ANÁLISE LABORATORIAL, TESTOSTERONE, THYROID STIMULATING HORMONE (TSH), THYROXINE (T4), TOTAL ANTIBODY TO HEPATITIS B VIRUS S ANTIGEN (ANTI-HBSAG), TOTAL ANTIBODY TO HEPATITIS C VIRUS (ANTI-HCV), TOTAL NUCLEAR ANTIBODY FOR HEPATITIS B VIRUS (ANTI-HBCAG), TOXOPLASMA GONDII, TREPONEMA PALLIDUM, TRIIODOTHYRONINE (T3), VITAMIN B12 (FOLIC ACID)

About this profile

Explore comprehensive manufacturer profile for ORTHO CLINICAL DIAGNOSTICS based in United Kingdom through Pure Global AI's free Brazil medical device database. This manufacturer has 70 products registered with ANVISA across 52 unique technical categories. Their regulatory history spans from Jul 28, 1997 to May 11, 2026.

This page provides detailed insights including 5 recent product registrations including TREPONEMA PALLIDUM, 5 most popular products with ANTI-HUMAN GLOBULIN (COOMBS) having 5 registrations, 2 registration holders including ORTHO CLINICAL DIAGNÓSTICS DO BRASIL PRODUTOS PARA SAÚDE LTDA, and 5 key competitors with ROCHE DIAGNOSTICS GMBH sharing 43 products. Pure Global AI offers free access to over 100,000+ Brazilian medical device registrations, enabling global MedTech companies to analyze market dynamics and identify opportunities.