DiaSys Diagnostics India Private Limited
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 54 |
| Class B | Low–moderate risk | 573 |
| Class C | Moderate–high risk | 121 |
| Class D (high risk) | Highest-risk devices | 0 |
CDSCO device licences
Mindray PTH Calibrators (PTH CAL) are intended to calibrate the quantitative PTH assay on Mindray CL-series Chemiluminescence Immunoassay Analyzer
IMP/IVD/2024/000118 · from ChinaMindray Anti-thyroid Antibodies Control is used for quality control by monitoring the accuracy and precision of Mindray CL-series Chemiluminescence Immunoassay Analyzer and test ability of clinical laboratory in the quantitative measurement…
IMP/IVD/2024/000118 · from ChinaMindray PCT Control is intended for monitoring system performance of PCT assay on Mindray CL-series Chemiluminescence Immunoassay Analyzer
IMP/IVD/2024/000118 · from ChinaMindray Anti-thyroid Antibodies Control is used for quality control by monitoring the accuracy and precision of Mindray CL-series Chemiluminescence Immunoassay Analyzer and test ability of clinical laboratory in the quantitative measurement…
IMP/IVD/2024/000118 · from ChinaMindray Anti-Tg Calibrators (Anti-Tg CAL) are intended to calibrate the quantitative antibody to thyroglobulin (Anti-Tg) assay on Mindray CL-series Chemiluminescence Immunoassay Analyzer.
IMP/IVD/2024/000118 · from ChinaMindray Thyroglobulin Calibrators (Tg CAL) are used for calibration of quantitative determination of thyroglobulin (Tg) analyte in human serum or plasma on Mindray CL-series Chemiluminescence Immunoassay Analyzer
IMP/IVD/2024/000118 · from ChinaThe CL-series Tg assay is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of thyroglobulin (Tg) in human serum or plasma. Determination of Tg is used as an aid in monitoring after thyroid ablation
IMP/IVD/2024/000118 · from ChinaMindray PCT Control is intended for monitoring system performance of PCT assay on Mindray CL-series Chemiluminescence Immunoassay Analyzer
IMP/IVD/2024/000118 · from ChinaThe CL-series PTH assay is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of Parathyroid hormone (PTH) in human serum or plasma. This assay can be used in diagnosing diseases related to primary and secondary parath…
IMP/IVD/2024/000118 · from ChinaThe CL-series Procalcitonin assay is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of procalcitonin? PCT? in human serum or plasma for the diagnosis and monitoring of bacterial infection and sepsis
IMP/IVD/2024/000118 · from ChinaThe CL-series Anti-Tg assay is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of Antibody to thyroglobulin (Anti-Tg) in human serum or plasma. The anti?Tg determination is used as an aid in the detection of autoimm…
IMP/IVD/2024/000118 · from ChinaMindray Anti-TPO Calibrators (Anti-TPO CAL) are intended to calibrate the quantitative antibodies to thyroid peroxidase (Anti-TPO) assay on Mindray CL-series Chemiluminescence Immunoassay Analyzer
IMP/IVD/2024/000118 · from ChinaThe CL-series CT assay is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of Calcitonin (CT) in human serum or plasma. The calcitonin determination is intended to be used as an aid in the diagnosis and treatment of …
IMP/IVD/2024/000118 · from ChinaThe CL-series Anti-TPO assay is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of Anti-TPO in human serum or plasma. The anti?TPO determination is used as an aid in the diagnosis of autoimmune thyroid diseases.
IMP/IVD/2024/000118 · from ChinaMindray PCT Calibrators (PCT CAL) are intended to calibrate the quantitative Procalcitonin (PCT) assay on Mindray CL-series Chemiluminescence Immunoassay Analyzer.
IMP/IVD/2024/000118 · from ChinaMindray Calcitonin Calibrators (CT CAL) are intended to calibrate the quantitative Calcitonin assay on Mindray CL-series Chemiluminescence Immunoassay Analyzer
IMP/IVD/2024/000118 · from ChinaCollagen Type IV Calibrators (C IV CAL) are intended to calibrate the quantitative Collagen Type IV (C IV) assay on DiaSys SYS Chemiluminescence Immunoassay Analyzer.
MFG/IVD/2022/000015 · Kokan DivisionHyaluronic Acid Calibrators (HA CAL) are intended to calibrate the quantitative Hyaluronic Acid (HA) assay on DiaSys SYS Chemiluminescence Immunoassay Analyzer.
MFG/IVD/2022/000015 · Kokan DivisionThe SYS series Collagen Type IV (C IV) assay is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of Collagen Type IV (C IV) in human serum. It can be used for the auxiliary diagnosis of liver fibrosis and cirrhosis. …
MFG/IVD/2022/000015 · Kokan DivisionThe SYS series Laminin assay is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of laminin (LN) in human serum. It can be used for the auxiliary diagnosis of liver fibrosis and cirrhosis. It is not intended to be us…
MFG/IVD/2022/000015 · Kokan DivisionThe SYS series Hyaluronic Acid (HA) assay is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of hyaluronic acid (HA) in human serum. It can be used for the auxiliary diagnosis of liver fibrosis a nd cirrhosis. It is…
MFG/IVD/2022/000015 · Kokan DivisionLaminin Calibrators (Laminin CAL) are intended to calibrate the quantitative Laminin (LN) assay on DiaSys SYS Chemiluminescence Immunoassay Analyzer.
MFG/IVD/2022/000015 · Kokan DivisionDiaSys Liver Fibrosis Multi Control is used for quality control by monitoring the accuracy and precision of DiaSys SYS series Chemiluminescence Immunoassay Analyzer and test ability of clinical laboratory in the quantitative measurement of …
MFG/IVD/2022/000015 · Kokan DivisionFor measurement of HDL-cholesterol in serum or plasma.
MFG/IVD/2022/000015 · Kokan DivisionThe Integrated Analyzer (Clinical Chemistry and Chemiluminescence Immunoassay) is an in vitro diagnostic (IVD) system intended for the quantitative and qualitative measurement of analytes in human specimens, including but not limited to ser…
MFG/IVD/2023/000132 · Kokan DivisionThe Integrated Analyzer (Clinical Chemistry and Chemiluminescence Immunoassay) is an in vitro diagnostic (IVD) system intended for the quantitative and qualitative measurement of analytes in human specimens, including but not limited to ser…
MFG/IVD/2023/000132 · Kokan DivisionMindray CK-MB Calibrators (CK-MB CAL) are intended to calibrate the quantitative Creatine kinase MB (CK-MB) assay on Mindray CL-series Chemiluminescence Immunoassay Analyzer.
IMP/IVD/2024/000118 · from ChinaMyoglobin Calibrators (MYO CAL) are intended to calibrate the quantitative Myoglobin (MYO) assay on Mindray CL-series Chemiluminescence Immunoassay Analyzer.
IMP/IVD/2024/000118 · from ChinaMindray Cortisol Calibrators (Cortisol CAL) are intended to calibrate the quantitative Cortisol assay on Mindray CL-series Chemiluminescence Immunoassay Analyzer.
IMP/IVD/2024/000118 · from ChinaThe CL-series AMH assay is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of AMH in human serum and heparin plasma. It can be used as an aid to manage reproductive endocrine diseases.
IMP/IVD/2024/000118 · from ChinaDHEA-S Calibrators (DHEA-S CAL) are intended to calibrate the quantitative ehydroepiandrosterone sulfate (DHEA-S) assay on Mindray CL-series Chemiluminescence Immunoassay Analyzer.
IMP/IVD/2024/000118 · from ChinaThe CL series Cortisol assay is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of Cortisol in human serum, plasma or urine. Measurements of cortisol are used in the diagnosis and treatment of adrenal gland related …
IMP/IVD/2024/000118 · from ChinaMindray ACTH Control is used for quality control by monitoring the accuracy and precision of Mindray CL-series Chemiluminescence Immunoassay Analyzer and test ability of clinical laboratory in the quantitative measurement of ACTH analyte.
IMP/IVD/2024/000118 · from ChinaThe CL-series ACTH assay is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of Adrenocorticotropic hormone (ACTH) in human EDTA plasma. ACTH measurements can be used as an aid in diagnosis of diseases related to adr…
IMP/IVD/2024/000118 · from ChinaMindray ACTH Control is used for quality control by monitoring the accuracy and precision of Mindray CL-series Chemiluminescence Immunoassay Analyzer and test ability of clinical laboratory in the quantitative measurement of ACTH analyte.
IMP/IVD/2024/000118 · from ChinaThe CL-series creatine kinase MB assay is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of creatine kinase MB (CK-MB) in human serum or plasma. The CK-MB assay is to be used to assist in the diagnosis of myocardia…
IMP/IVD/2024/000118 · from ChinaThe CL-series Myoglobin assay is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of myoglobin (MYO) in human serum or plasma. Myoglobin could be used as an early phase biological marker to diagnose acute myocardial …
IMP/IVD/2024/000118 · from ChinaThe CL-series DHEA-S assay is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of Dehydroepiandrosterone sulfate (DHEA-S) in human serum or plasma. Measurements of DHEA-S are used to aid in the diagnostic work?up of …
IMP/IVD/2024/000118 · from ChinaMindray Testosterone Calibrators (TESTO CAL) are intended to calibrate the quantitative testosterone (TESTO) assay on Mindray CL-series Chemiluminescence Immunoassay Analyzer.
IMP/IVD/2024/000118 · from ChinaThe CL-series TESTO assay is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of testosterone (TESTO) in human serum and plasma. Measurements of testosterone are used in the diagnosis and treatment of diseases involv…
IMP/IVD/2024/000118 · from ChinaThe Mindray CL-series TnI assay is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of TnI in human serum or plasma. This assay can be used as an aid in the differential diagnosis of acute coronary syndrome (ACS), es…
IMP/IVD/2024/000118 · from ChinaMindray ACTH Calibrators (ACTH CAL) are intended to calibrate the quantitative Adrenocorticotropic hormone (ACTH) assay on Mindray CL-series Chemiluminescence Immunoassay Analyzer.
IMP/IVD/2024/000118 · from ChinaMindray Troponin I Calibrators (TnI CAL) are intended to calibrate the quantitative Troponin I (TnI) assay on Mindray CL-series Chemiluminescence Immunoassay Analyzer.
IMP/IVD/2024/000118 · from ChinaIt is used to clean the electrodes flowcell as well as the pipeline of the ISE module
MFG/IVD/2022/000015 · Kokan DivisionIt Is used to dilute samples before they are disposed to the electrodes flowcell.
MFG/IVD/2022/000015 · Kokan DivisionSerum Standard is Intended for use as calibrator for In vitro testing for the quantitative determination of sodium, potassium and chloride concentration in serum and plasma sample on ion-selective electrode on ISE Modules on series automati…
MFG/IVD/2022/000015 · Kokan DivisionThe product, based on the indirect chemiluminescence method integrating AMPPD and alkaline phosphatase, is clinically applied in combination with the matching reagent to qualitatively or quantitatively detecting analytes in serum, plasma an…
MFG/IVD/2023/000132 · Kokan DivisionTo clean sample and reagent probes, Mixers and cuvettes of the chemistry analyser.
MFG/IVD/2022/000015 · Kokan DivisionCA15-3 assay is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of cancer antigen 15-3 (CA15-3) in human serum or plasma.
MFG/IVD/2022/000092CEA assay is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of carcinoembryonic antigen (CEA) in human serum or plasma.
MFG/IVD/2022/000092Global 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.