Trivitron Healthcare Pvt. Ltd.
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 43 |
| Class B | Low–moderate risk | 397 |
| Class C | Moderate–high risk | 99 |
| Class D (high risk) | Highest-risk devices | 18 |
CDSCO device licences
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 ChinaBH-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 ChinaThe 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 NaduThe 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 NaduClinReact® Rinsing solution is used for probes, tubings and chambers cleaning and rinsing of clinical chemistry analyzers.
MFG/IVD/2020/000037 · Tamil NaduThe ClinReact SyPA® Albumin (By BCG Method) is intended for the quantitative determination of Albumin in human serum or plasma.
MFG/IVD/2020/000037 · Tamil NaduThe 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 NaduAn 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 NaduThe 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 NaduThe 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 NaduThe 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 NaduAn 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 NaduAn 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 NaduThe 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 NaduClinReact SyPA® Cuvette Cleaner solution is intended to clean cuvette as part of routine maintenance of clinical chemistry analysers.
MFG/IVD/2020/000037 · Tamil NaduHb Variants Control- HPLC Method Material is intended for the system quality control for accuracy and repeatability.
MFG/IVD/2020/000037 · Tamil NaduClinReact 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 NaduThe 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 NaduThe 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 NaduHbA1C 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 NaduBiocard 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 NaduThe 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 NaduClinReact® 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 NaduThe ClinReact SyPA® LDH-P is intended for the quantitative measurement of Lactate Dehydrogenase (LDH) concentration in serum or plasma.
MFG/IVD/2020/000037 · Tamil NaduThe 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 NaduThe 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 NaduThe 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 NaduThe 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 NaduThe 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 NaduClinReact® Hypochlorite cleaning solution is used for probes, tubings and chambers cleaning and rinsing of clinical chemistry analyzers.
MFG/IVD/2020/000037 · Tamil NaduHbA1c Control- HPLC Method Material is intended for the system quality control for accuracy and repeatability.
MFG/IVD/2020/000037 · Tamil NaduClinReact SyPA® Additive wash solution is used for cuvettes cleaning and rinsing of clinical chemistry analyzers.
MFG/IVD/2020/000037 · Tamil NaduHPLC 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 NaduAn 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 NaduThe 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 NaduThe 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 NaduThe 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 NaduThe 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 NaduThe 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 NaduNeonatal 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/2020/000053The 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/2020/000053Neonatal IRT kit is for enzymatic determination of human immunoreactive trypsinogen from blood samples dried on filter paper.
MFG/IVD/2020/000053ClinReact 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/2020/000053ClinReact 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/2020/000053ClinReact 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/2020/000053ClinReact 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/2020/000053The 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/2020/000053ClinReact 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/2020/000053ClinReact 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/2020/000053Biocard 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/2020/000053Global footprint
Cross-railThe 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.