Importer / authorised agent · Maharashtra · India

DiaSys Diagnostics India Private Limited

CDSCO licensing intelligence, reconciled with the manufacturer’s global footprint · AI-reviewed · expert verification in progress — not yet independently verified.
CDSCO licences
748
Manufacturing
346
Import
402
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices54
Class BLow–moderate risk573
Class CModerate–high risk121
Class D (high risk)Highest-risk devices0

CDSCO device licences

PTH Calibrators · Class BIMPORT · 2026-04-27

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 China
Anti-thyroid Antibodies Control (H) · Class BIMPORT · 2026-04-27

Mindray 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 China
PCT Control (H) · Class CIMPORT · 2026-04-27

Mindray PCT Control is intended for monitoring system performance of PCT assay on Mindray CL-series Chemiluminescence Immunoassay Analyzer

IMP/IVD/2024/000118 · from China
Anti-thyroid Antibodies Control (L) · Class BIMPORT · 2026-04-27

Mindray 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 China
Anti-Tg Calibrators · Class BIMPORT · 2026-04-27

Mindray 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 China
Thyroglobulin Calibrators · Class CIMPORT · 2026-04-27

Mindray 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 China
Thyroglobulin TG (CLIA) · Class CIMPORT · 2026-04-27

The 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 China
PCT Control (L) · Class CIMPORT · 2026-04-27

Mindray PCT Control is intended for monitoring system performance of PCT assay on Mindray CL-series Chemiluminescence Immunoassay Analyzer

IMP/IVD/2024/000118 · from China
Parathyroid hormone PTH (CLIA) · Class BIMPORT · 2026-04-27

The 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 China
Procalcitonin PCT (CLIA) · Class CIMPORT · 2026-04-27

The 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 China
Antibodies to Thyroglobulin Anti-Tg (CLIA) · Class BIMPORT · 2026-04-27

The 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 China
Anti-TPO Calibrators · Class BIMPORT · 2026-04-27

Mindray 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 China
Calcitonin CT (CLIA) · Class CIMPORT · 2026-04-27

The 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 China
Antibody to thyroid peroxidase Anti-TPO (CLIA) · Class BIMPORT · 2026-04-27

The 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 China
PCT Calibrators · Class CIMPORT · 2026-04-27

Mindray 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 China
Calcitonin Calibrators · Class CIMPORT · 2026-04-27

Mindray Calcitonin Calibrators (CT CAL) are intended to calibrate the quantitative Calcitonin assay on Mindray CL-series Chemiluminescence Immunoassay Analyzer

IMP/IVD/2024/000118 · from China
Collagen Type IV Calibrators · Class BMFG · 2026-03-27

Collagen 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 Division
Hyaluronic Acid Calibrators · Class BMFG · 2026-03-27

Hyaluronic 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 Division
Collagen Type IV (CLIA) · Class BMFG · 2026-03-27

The 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 Division
Laminin (CLIA) · Class BMFG · 2026-03-27

The 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 Division
Hyaluronic Acid (CLIA) · Class BMFG · 2026-03-27

The 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 Division
Laminin Calibrators · Class BMFG · 2026-03-27

Laminin Calibrators (Laminin CAL) are intended to calibrate the quantitative Laminin (LN) assay on DiaSys SYS Chemiluminescence Immunoassay Analyzer.

MFG/IVD/2022/000015 · Kokan Division
Liver Fibrosis Multi Control · Class BMFG · 2026-03-27

DiaSys 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 Division
HDL-C Direct FS test kit · Class BMFG · 2026-03-17

For measurement of HDL-cholesterol in serum or plasma.

MFG/IVD/2022/000015 · Kokan Division
Integrated Analyzer (Clinical Chemistry + Chemiluminescence Immunoassay) · Class AMFG · 2026-02-17

The 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 Division
Integrated Analyzer (Clinical Chemistry + Chemiluminescence Immunoassay) · Class AMFG · 2026-02-17

The 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 Division
CK-MB Calibrators · Class BIMPORT · 2026-02-06

Mindray 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 China
MYO Calibrators · Class BIMPORT · 2026-02-06

Myoglobin Calibrators (MYO CAL) are intended to calibrate the quantitative Myoglobin (MYO) assay on Mindray CL-series Chemiluminescence Immunoassay Analyzer.

IMP/IVD/2024/000118 · from China
Cortisol Calibrators · Class BIMPORT · 2026-02-06

Mindray Cortisol Calibrators (Cortisol CAL) are intended to calibrate the quantitative Cortisol assay on Mindray CL-series Chemiluminescence Immunoassay Analyzer.

IMP/IVD/2024/000118 · from China
Anti-Mullerian Hormone test reagent/kit · Class BIMPORT · 2026-02-06

The 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 China
DHEA-S Calibrators · Class BIMPORT · 2026-02-06

DHEA-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 China
Cortisol test reagent/kit · Class BIMPORT · 2026-02-06

The 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 China
ACTH Control · Class BIMPORT · 2026-02-06

Mindray 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 China
Adrenocorticotropic Hormone (ACTH) test reagent/kit · Class BIMPORT · 2026-02-06

The 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 China
ACTH Control · Class BIMPORT · 2026-02-06

Mindray 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 China
Creatine Kinase (CK) and CKMB test · Class BIMPORT · 2026-02-06

The 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 China
Myoglobin test reagents/ kit · Class BIMPORT · 2026-02-06

The 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 China
Dehydroepiandrosterone (DHEA -S) (free and sulfate) test reagent/ kit · Class BIMPORT · 2026-02-06

The 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 China
Testosterone Calibrator · Class BIMPORT · 2026-02-06

Mindray 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 China
Testosterone test reagent/ kit · Class BIMPORT · 2026-02-06

The 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 China
Troponin test reagent/ kit · Class CIMPORT · 2026-02-06

The 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 China
ACTH Calibrators · Class BIMPORT · 2026-02-06

Mindray 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 China
Troponin I Calibrators · Class CIMPORT · 2026-02-06

Mindray 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 China
Detergent Solution · Class BMFG · 2026-02-02

It is used to clean the electrodes flowcell as well as the pipeline of the ISE module

MFG/IVD/2022/000015 · Kokan Division
Buffer Solution · Class BMFG · 2026-02-02

It Is used to dilute samples before they are disposed to the electrodes flowcell.

MFG/IVD/2022/000015 · Kokan Division
Serum Standard (High and Low) SYS 2000 ci · Class BMFG · 2026-02-02

Serum 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 Division
Chemiluminescence Immunoassay analyzer · Class AMFG · 2026-02-02

The 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 Division
Acid Detergent (DA) · Class BMFG · 2026-02-02

To clean sample and reagent probes, Mixers and cuvettes of the chemistry analyser.

MFG/IVD/2022/000015 · Kokan Division
Cancer Antigen 15-3 CA 15-3 (CLIA) · Class CMFG · 2025-11-28

CA15-3 assay is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of cancer antigen 15-3 (CA15-3) in human serum or plasma.

MFG/IVD/2022/000092
Carcinoembryonic Antigen CEA (CLIA) · Class CMFG · 2025-11-28

CEA assay is a Chemiluminescent Immunoassay (CLIA) for the quantitative determination of carcinoembryonic antigen (CEA) in human serum or plasma.

MFG/IVD/2022/000092

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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