Importer / authorised agent · Tamil Nadu · India

Trivitron Healthcare Pvt. Ltd.

CDSCO licensing intelligence, reconciled with the manufacturer’s global footprint · AI-reviewed · expert verification in progress — not yet independently verified.
CDSCO licences
557
Manufacturing
261
Import
296
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices43
Class BLow–moderate risk397
Class CModerate–high risk99
Class D (high risk)Highest-risk devices18

CDSCO device licences

5-Part-Diff Auto Hematology Analyzer · Class AIMPORT · 2026-05-07

URIT-5380 5-Part-Diff Auto Hematology Analyzer, which is a vitro diagnostic medical device, is used for blood cell count, WBC five part differential and hemoglobin concentration measurement in clinical tests. The analyzer provides accurate …

IMP/IVD/2021/000312 · from China
5-Part-Diff Auto Hematology Analyzer · Class AIMPORT · 2026-05-07

BH-5390 5-Part-Diff Auto Hematology Analyzer, which is a vitro diagnostic medical device, is used for blood cell count, WBC five part differential, hemoglobin concentration measurement, and body fluid cell count in clinical tests. The analy…

IMP/IVD/2021/000312 · from China
Calcium Test Reagent (By Arsenazo III Method) For Nanolab Series Analysers · Class BMFG · 2026-04-17

The ClinReact SyPA® Calcium Test Reagent (By Arsenazo III Method) For Nanolab Series Analysers is intended for the quantitative determination of Calcium in human serum or plasma.

MFG/IVD/2020/000037 · Tamil Nadu
Microalbumin Test Reagent Kit (By Turbilatex Method) For Nanolab Series Analyzer · Class BMFG · 2026-04-17

The ClinReact SyPA® Microalbumin Test Reagent Kit (By Turbilatex Method) For Nanolab Series Analyzer is intended for the quantitative determination of Microalbumin in human urine.

MFG/IVD/2020/000037 · Tamil Nadu
Rinsing Solution · Class BMFG · 2026-04-17

ClinReact® Rinsing solution is used for probes, tubings and chambers cleaning and rinsing of clinical chemistry analyzers.

MFG/IVD/2020/000037 · Tamil Nadu
Albumin Test Reagent (By BCG Method) for Nanolab Series Analyzer · Class BMFG · 2026-04-17

The ClinReact SyPA® Albumin (By BCG Method) is intended for the quantitative determination of Albumin in human serum or plasma.

MFG/IVD/2020/000037 · Tamil Nadu
Ferritin Test Reagent Kit (By Turbilatex Method) For Nanolab Series Analyzer · Class BMFG · 2026-04-17

The ClinReact SyPA® Ferritin Test Reagent Kit (By Turbilatex Method) For Nanolab Series Analyzer is intended for the quantitative determination of Ferritin in human serum.

MFG/IVD/2020/000037 · Tamil Nadu
Fully -Automated Clinical Chemistry Analyzer · Class AMFG · 2026-04-17

An analyzer intended to be used for the quantitative determination of one or multiple clinical chemistry analytes in a clinical specimen. It is intended for invitro diagnostic use.

MFG/IVD/2020/000037 · Tamil Nadu
ANTI STREPOLYSIN -O TEST REAGENT KIT( BY TURBILATEX METHOD)- FOR NANOLAB SERIES ANALYZER · Class BMFG · 2026-04-17

The ClinReact SyPA® Anti-Streptolysin O Test Reagent kit (by Turbilatex Method) is intended for the quantitative determination of Anti-streptolysin O (ASO) in human serum or plasma, specifically for use with Nanolab automatic analysers

MFG/IVD/2020/000037 · Tamil Nadu
Bilirubin Total Test Reagent Kit (By DIAZO Method) For Nanolab Series Analyzer · Class BMFG · 2026-04-17

The ClinReact SyPA ® Bilirubin Total Test Reagent (by Diazo Method) kit is intended for the quantitative measurement of total bilirubin in serum or plasma samples.

MFG/IVD/2020/000037 · Tamil Nadu
ADENOSINE DEAMINASE TEST REAGENT KIT (BY PNP-XOD METHOD)- FOR NANOLAB SERIES ANALYZER · Class BMFG · 2026-04-17

The ClinReact SyPA® Adenosine Deaminase Reagent Test Kit (By PNP-XOD method) kit for Nanolab systems is intended for the quantitative determination of adenosine deaminase in human serum specifically used for Nanolab automated analysers.

MFG/IVD/2020/000037 · Tamil Nadu
3 Part Differential Haematology Analyzer · Class AMFG · 2026-04-17

An analyzer intended to analyze in-vitro samples of whole blood to provide complete blood count, leucocyte differential count, classify and/or enumerate various parameters using the impedance and spectrophotometry techniques. It is intended…

MFG/IVD/2020/000037 · Tamil Nadu
5-Part Differential Haematology Analyzer · Class AMFG · 2026-04-17

An analyzer intended to analyze in-vitro samples of whole blood to provide complete blood count, leucocyte differential count, classify and/or enumerate various parameters using the impedance and spectrophotometry techniques. It is intended…

MFG/IVD/2020/000037 · Tamil Nadu
Alkaline Phosphatase Test Reagent Kit (By IFCC Method) for Nanolab Series Analyzer · Class BMFG · 2026-04-17

The ClinReact SyPA® Alkaline Phosphatase Test Reagent Kit (By IFCC Method) is intended for the quantitative measurement of Alkaline Phosphatase Activity in serum or plasma. The Test kit is intended to be used as diagnostic test by healthcar…

MFG/IVD/2020/000037 · Tamil Nadu
Cuvette Cleaner Solution · Class BMFG · 2026-04-17

ClinReact SyPA® Cuvette Cleaner solution is intended to clean cuvette as part of routine maintenance of clinical chemistry analysers.

MFG/IVD/2020/000037 · Tamil Nadu
Hb Variants Control -HPLC Method · Class BMFG · 2026-04-17

Hb Variants Control- HPLC Method Material is intended for the system quality control for accuracy and repeatability.

MFG/IVD/2020/000037 · Tamil Nadu
CUVETTE WASH SOLUTION · Class BMFG · 2026-04-17

ClinReact SyPA® Cuvette wash solution is intended to clean cuvette as part of routine maintenance of Nanolab 200 & other fully automated analyzers.

MFG/IVD/2020/000037 · Tamil Nadu
URIC ACID Test Reagent Kit (By AOX Method) For Nanolab Series Analyzer · Class BMFG · 2026-04-17

The ClinReact SyPA® URIC ACID Test Reagent Kit (By AOX Method) For Nanolab Series Analyzer is intended for the quantitative determination of URIC ACID in human serum.

MFG/IVD/2020/000037 · Tamil Nadu
SGOT/AST Test Reagent Kit (By IFCC Method) For Nanolab Series Analyzer · Class BMFG · 2026-04-17

The ClinReact SyPA® SGOT/AST Test Reagent Kit (By IFCC Method) For Nanolab Series Analyzer is intended for the quantitative determination of SGOT/AST in human serum.

MFG/IVD/2020/000037 · Tamil Nadu
HbA1C Calibrator - HPLC Method · Class BMFG · 2026-04-17

HbA1C Calibrator- HPLC Method is intended for the percent determination of HbA1c in human blood using High Performance Liquid Chromatography (HPLC).

MFG/IVD/2020/000037 · Tamil Nadu
Typhoid IgG/IgM Rapid Test Kit by immunochromatographic lateral flow method. · Class BMFG · 2026-04-17

Biocard Typhoid IgG/IgM Rapid Test is a Lateral Flow Chromatographic Immunoassay for the qualitative detection and differentiation of anti-Salmonella typhi (S. typhi) and paratyphi IgG and IgM in human serum or plasma. The Test kit is inten…

MFG/IVD/2020/000037 · Tamil Nadu
Creatinine Test Reagent Kit (By Alkaline Picrate Method) For Nanolab Series Analyser · Class BMFG · 2026-04-17

The ClinReact SyPA® Creatinine Test Reagent (By Alkaline Picrate Method) For Nanolab Series Analysers is intended for the quantitative determination of Creatinine in human serum or plasma.

MFG/IVD/2020/000037 · Tamil Nadu
Flowcell Wash Solution · Class BMFG · 2026-04-17

ClinReact® Flowcell Wash Solution is intended to clean flow cell as part of routine maintenance of Labmate & other semi-automated analyzers.

MFG/IVD/2020/000037 · Tamil Nadu
LDH-P Test Reagent Kit(By Pyruvate to Lactate Method) For Nanolab Series Analyzer · Class BMFG · 2026-04-17

The ClinReact SyPA® LDH-P is intended for the quantitative measurement of Lactate Dehydrogenase (LDH) concentration in serum or plasma.

MFG/IVD/2020/000037 · Tamil Nadu
Magnesium Test Reagent Kit (by Xylidyl Blue Method) For Nanolab Series Analyzer · Class BMFG · 2026-04-17

The ClinReact SyPA ® Magnesium Test Reagent Kit (by Xylidyl Blue Method) For Nanolab Series Analyzer is intended for the quantitative measurement of Magnesium in Human serum or plasma.

MFG/IVD/2020/000037 · Tamil Nadu
CHOLESTEROL Test Reagent (CHOD/POD Method) For Nanolab Series Analysers · Class BMFG · 2026-04-17

The ClinReact SyPA® CHOLESTEROL Test Reagent (CHOD/POD Method) For Nanolab Series Analysers is intended for the quantitative measurement of total cholesterol concentrations in serum or plasma.

MFG/IVD/2020/000037 · Tamil Nadu
SGPT/ALT Test Reagent Kit (By IFCC Method) For Nanolab Series Analyzer · Class BMFG · 2026-04-17

The ClinReact SyPA® SGPT/ALT Test Reagent Kit (By IFCC Method) For Nanolab Series Analyzer is intended for the quantitative determination of SGPT/ALT in human serum.

MFG/IVD/2020/000037 · Tamil Nadu
UREA Test Reagent Kit (By GLDH-UV Method) For Nanolab Series Analyzer · Class BMFG · 2026-04-17

The ClinReact SyPA® UREA Test Reagent Kit (By GLDH-UV Method) For Nanolab Series Analyzer is intended for the quantitative determination of UREA in human serum.

MFG/IVD/2020/000037 · Tamil Nadu
Phosphorus Test Reagent Kit (by UV Method) For Nanolab Series Analyzer · Class BMFG · 2026-04-17

The ClinReact SyPA ® Phosphorus Test Reagent Kit (by UV Method) For Nanolab Series Analyzer is intended for the quantitative measurement of Phosphorus in Human serum or plasma.

MFG/IVD/2020/000037 · Tamil Nadu
Hypochlorite cleaning solution · Class BMFG · 2026-04-17

ClinReact® Hypochlorite cleaning solution is used for probes, tubings and chambers cleaning and rinsing of clinical chemistry analyzers.

MFG/IVD/2020/000037 · Tamil Nadu
HbA1C Control -HPLC Method · Class BMFG · 2026-04-17

HbA1c Control- HPLC Method Material is intended for the system quality control for accuracy and repeatability.

MFG/IVD/2020/000037 · Tamil Nadu
Additive wash solution · Class BMFG · 2026-04-17

ClinReact SyPA® Additive wash solution is used for cuvettes cleaning and rinsing of clinical chemistry analyzers.

MFG/IVD/2020/000037 · Tamil Nadu
Hb Variants Calibrator -HPLC Method · Class BMFG · 2026-04-17

HPLC Hb Variants Calibrator is intended for the percent determination of HbA2 / HbF / HbA1c in human blood using High Performance Liquid Chromatography (HPLC).

MFG/IVD/2020/000037 · Tamil Nadu
Semi-Automatic Biochemistry Analyzer · Class AMFG · 2026-04-17

An analyzer intended for measuring and analyzing various biologic and chemical elements of human body fluid. It is intended for in-vitro diagnostic use.

MFG/IVD/2020/000037 · Tamil Nadu
Bilirubin Direct Test Reagent Kit (By DIAZO Method) For Nanolab Series Analyzer · Class BMFG · 2026-04-17

The ClinReact SyPA® Bilirubin Direct Test Reagent Kit (By Diazo Method) For Nanolab Series Analyzer is intended for the quantitative measurement of conjugated (direct) bilirubin in serum or plasma.

MFG/IVD/2020/000037 · Tamil Nadu
Enzymatic Creatinine Test Reagent Kit (By Enzymatic Method) for Nanolab Series Analyzer · Class BMFG · 2026-04-17

The ClinReact SyPA® Enzymatic Creatinine Test Reagent kit (by Enzymatic Method) for Nanolab Series Analyser is intended for the quantitative determination of Creatinine in human serum or urine, specifically for use with Nanolab series.

MFG/IVD/2020/000037 · Tamil Nadu
?-Glutamyl Transferase (GAMMA GT) Test Reagent Kit (By IFCC Method) For Nanolab Series Analyzer · Class BMFG · 2026-04-17

The ClinReact SyPA® Glutamyl Transferase (Gamma-GT) for Nanolab series Analyzer is intended for the quantitative measurement of gamma glutamyltransferase activity in serum, plasma or urine by IFCC method.

MFG/IVD/2020/000037 · Tamil Nadu
Lipase Test Reagent kit (By Methyl Resorufin Method) For Nanolab Series Analyzer · Class BMFG · 2026-04-17

The ClinReact SyPA® Lipase Test Reagent kit (By Methyl Resorufin Method) For Nanolab Series Analyzer is intended for the quantitative determination of Lipase concentrations in human serum or plasma.

MFG/IVD/2020/000037 · Tamil Nadu
HDL Cholesterol Test Reagent kit (By Direct Method) For Nanolab Series Analysers · Class BMFG · 2026-04-17

The ClinReact SyPA® HDL Cholesterol Reagent Kit (By Direct Method) For Nanolab Series Analysers is intended for the quantitative determination of HDL Cholesterol in human serum or plasma.

MFG/IVD/2020/000037 · Tamil Nadu
Neonatal GALT FEIA Test Kit · Class CMFG · 2026-04-01

Neonatal GALT kit is for enzymatic determination of human GALT enzyme activity from blood samples dried on filter paper. Intended for newborn screening for GALT deficiency.

MFG/IVD/2020/000053
Malaria Pf/Pan Rapid Test Kit · Class CMFG · 2026-03-17

The BIOCARD® Malaria Pf/Pan Rapid test is an immunochromatographic assay for the qualitative detection of Plasmodium falciparum (Pf) and Pan malaria species (P. falciparum, P. vivax, P. ovale, and P. malariae) antigen in the human whole Blo…

MFG/IVD/2020/000053
NEONATAL IRT FEIA KIT · Class CMFG · 2026-03-17

Neonatal IRT kit is for enzymatic determination of human immunoreactive trypsinogen from blood samples dried on filter paper.

MFG/IVD/2020/000053
C-Reactive Protein Test Reagent kit (by Turbilatex Method) for Nanolab 500 Analyzer · Class CMFG · 2026-03-12

ClinReact SyPA C-Reactive Protein Test Reagent kit (by Turbilatex Method) for Nanolab 500 Analyzer is intended for the quantitative determination of Creactive protein (CRP) in human serum or plasma, specifically for use with Nanolab 500 Ana…

MFG/IVD/2020/000053
D-dimer Test Reagent kit (by Turbilatex Method) for Nanolab 200 Analyzer · Class CMFG · 2026-03-12

ClinReact SyPA D-dimer Test Reagent kit (by Turbilatex Method) for Nanolab 200 Analyzer is intended for the quantitative determination of D-Dimer in human serum, specifically used for Nanolab 200 analyzer

MFG/IVD/2020/000053
D-dimer Test Reagent kit (by Turbilatex Method) · Class CMFG · 2026-03-12

ClinReact ITA D-dimer Test Reagent kit (by Turbilatex Method) is intended for the quantitative determination of D-Dimer in human serum by spectrophotometry

MFG/IVD/2020/000053
C-Reactive Protein Test Reagent kit (by Turbilatex Method) for Nanolab 200 Analyzer · Class CMFG · 2026-03-12

ClinReact SyPA C-Reactive Protein Test Reagent kit (by Turbilatex Method) for Nanolab 200 Analyzer is intended for the quantitative determination of C reactive protein (CRP) in human serum or plasma, specifically for use with Nanolab 200 An…

MFG/IVD/2020/000053
Dengue Ag (NS1) Rapid Test Kit · Class CMFG · 2026-03-12

The Biocard® Dengue Ag (NS1) Rapid Test Kit is a rapid immunochromatographic test for the qualitative detection of Dengue NS1 Antigen in the human serum/plasma. This test is for in-vitro diagnostic use only and is intended as an aid in the…

MFG/IVD/2020/000053
D-dimer Test Reagent kit (by Turbilatex Method) for Nanolab 500 Analyzer · Class CMFG · 2026-03-12

ClinReact SyPA D-dimer Test Reagent kit (by Turbilatex Method) for Nanolab 500 Analyzer is intended for the quantitative determination of D-Dimer in human serum, specifically used for Nanolab 500 analyzer.

MFG/IVD/2020/000053
C-Reactive Protein Test Reagent kit (by Turbilatex Method) · Class CMFG · 2026-03-12

ClinReact ITA C-Reactive Protein Test Reagent kit (by Turbilatex Method) is intended for the quantitative determination of C-reactive protein (CRP) in human serum or plasma by spectrophotometry.

MFG/IVD/2020/000053
HCV RAPID TEST KIT · Class DMFG · 2026-03-10

Biocard HCV Rapid test is an immunochromatographic immunoassay for the qualitative detection of anti-Hepatitis C Virus antibodies (IgG, IgM and IgA) in human serum, plasma and Whole Blood.

MFG/IVD/2020/000053

Global footprint

Cross-rail

The same manufacturer across regulators — 0 FDA clearances, 0 flagged adverse-event signals.

No FDA clearances linked — India-domestic footprint.

Sources: CDSCO (Central Drugs Standard Control Organisation) device licences · openFDA 510(k)/PMA · openFDA MAUDE · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert sign-off in progress.

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