Domestic manufacturer · Gujarat · India

Meril Diagnostics Pvt. Ltd.

CDSCO licensing intelligence, reconciled with the manufacturer’s global footprint · AI-reviewed · expert verification in progress — not yet independently verified.
CDSCO licences
1,014
Manufacturing
968
Import
46
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices112
Class BLow–moderate risk548
Class CModerate–high risk245
Class D (high risk)Highest-risk devices109

CDSCO device licences

LDL Cholesterol ( Direct) Kit · Class BMFG · 2026-04-28

This reagent is intended for quantitative determination of low-density lipoprotein cholesterol (LDL-C) concentration in human serum or plasma.

MFG/MD/2018/000022 · Gujarat
LDL Cholesterol ( Direct) Kit · Class BMFG · 2026-04-28

This reagent is intended for quantitative determination of low-density lipoprotein cholesterol (LDL-C) concentration in human serum or plasma.

MFG/MD/2018/000022 · Gujarat
BF-FDO Lyse · Class BIMPORT · 2026-04-22

For the dissolution of red blood cells, dye of cell, content detection of lymphocyte, monocyte, eosinophil and neutrophil

IMP/IVD/2020/001080 · from China
BF-FDT Lyse · Class BIMPORT · 2026-04-22

For the dissolution of red blood cells, dye of cell, content detection of lymphocyte, monocyte, eosinophil and neutrophil

IMP/IVD/2020/001080 · from China
HPV Genotyping RT-PCR Kit · Class CMFG · 2026-04-02

It is a genotyping RT-PCR assay for the detection of high risk HPV viral DNA molecules from cervical swab and urine specimens. The assay implements multiplex TaqMan real time PCR to amplify, detect and differentiate 7 high-risk HPV genotype…

MFG/MD/2018/000029
MDR TB RT-PCR Kit · Class CMFG · 2026-04-01

It is an in vitro diagnostic test, based on real time PCR system designed for the detection of MTB complex specific DNA, mutation in the 507-533 amino acid codon region of the rpoB gene that causes MTB Rifampicin resistance and mutation in …

MFG/MD/2018/000029
Triple H RT-PCR Kit · Class DMFG · 2026-03-24

MERINAT? Triple H RT-PCR Kit is an in vitro RT-PCR assay for the detection of HIV-1, HIV-2, HBV and HCV viral nucleic acid molecules from the plasma, serum and whole blood specimens. The kit includes master-mix, primer-probes specific to ea…

MFG/MD/2018/000029
RNA Blood Preservative Tube · Class AMFG · 2026-03-15

The GENEMAP RNA Blood Preservative Tube is intended for the collection, stabilization, transport, and storage of venous whole blood specimens for the preservation of intracellular RNA for subsequent isolation and molecular analysis. Stabili…

MFG/MD/2018/000022 · Gujarat
Ceruloplasmin Test Kit · Class BMFG · 2026-03-05

Ceruloplasmin Test Kit is a medical device intended for the estimation of Ceruloplasmin in human serum.

MFG/MD/2018/000022 · Gujarat
Ceruloplasmin Test Kit · Class BMFG · 2026-03-05

Ceruloplasmin Test Kit is a medical device intended for the estimation of Ceruloplasmin in human serum.

MFG/MD/2018/000022 · Gujarat
One Step test for hCG · Class BMFG · 2026-03-05

EZEEFIND? Ultra hCG is a rapid immuno-chromatographic test device for qualitative detection of human chorionic gonadotropin (hCG) in human urine to aid in the early detection of pregnancy.

MFG/MD/2018/000022 · Gujarat
Dengue IgG/IgM Antibody Detection Test · Class BMFG · 2026-02-28

Dengue IgG/IgM Antibody Detection Test kit is a medical device intended for the detection of Dengue Antibody in blood/body fluids i.e human serum, plasma or whole blood.

MFG/MD/2018/000022 · Gujarat
MTB Detection Assay (Extraction Free Real-Time Qualitative PCR Kit) · Class CMFG · 2026-02-16

MERINAT ? MTB Detection Assay (Extraction Free Real-Time Qualitative PCR Kit) is an in vitro diagnostic test, based on real time PCR system for the detection of Mycobacterium tuberculosis complex specific DNA in human sputum and bronchoalve…

MFG/MD/2018/000029
Nucleic Acid Extraction Kit (Magnetic automated machine based) · Class CMFG · 2026-02-12

This kit is intended for the high-throughput extraction of nucleic acids from sputum samples. The extracted Nucleic Acid is highly purified and in quantity, can be widely used in the fields of molecular diagnostics.

MFG/MD/2018/000029
Cervical Swab and Urine Collection Kit · Class AMFG · 2026-01-12

The MERINAT? Cervical Swab and Urine Collection Kit is indented for the safe and efficient collection, preservation, and transport of clinical specimens?specifically cervical swabs and urine samples?for downstream molecular testing, such as…

MFG/IVD/2025/000106 · Gujarat
TB RT-PCR Kit (Version 2.0) · Class CMFG · 2025-12-02

It is an in vitro qualitative diagnostic test, based on real time PCR system for the detection of Mycobacterium tuberculosis complex specific DNA in human sputum and bronchial secretion. The test results of this kit are for clinical refere…

MFG/MD/2018/000029
hs-CRP+CRP Fluorescence Immunoassay Test · Class CMFG · 2025-11-18

hs-CRP+CRP Test Kit (Immunofluorescence Assay) is intended for in vitro quantitative determination of C-reactive protein (CRP) in human serum, plasma, whole blood or fingertip blood samples. Measurement of CRP is useful for the detection a…

MFG/MD/2018/000029
Cardiac Tropinin I Fluorescence Immunoassay Test Kit · Class CMFG · 2025-11-18

Cardiac Troponin I Test Kit (Immunofluorescence Assay) is intended for in vitro quantitative determination of Cardiac Troponin I (cTnI) in human serum, plasma or whole blood samples, This test is used as an aid in the diagnosis of myocardia…

MFG/MD/2018/000029
NT-proBNP Fluorescence Immunoassay Test Kit · Class CMFG · 2025-11-18

NT-proBNP Test Kit (Immunofluorescence Assay) is intended for in vitro quantitative determination of N-terminal B-type natriuretic peptide precursor (NT-proBNP) in human serum, plasma or whole blood samples This test is used as an aid in th…

MFG/MD/2018/000029
D-Dimer Fluorescence Immunoassay Test Kit · Class CMFG · 2025-11-18

D-Dimer Test Kit (Immunofluorescence Assay) is intended for in vitro quantitative determination of D-Dimer in human plasma or whole blood samples. The test is used as an aid in the assessment and evaluation of patients suspected of deep-vei…

MFG/MD/2018/000029
HLA B27 RT-PCR Kit · Class CMFG · 2025-11-07

The HLA B27 RT-PCR Kit is an in vitro diagnostic Real-Time PCR assay intended for the qualitative detection of HLA-B27 alleles in human whole blood specimen. The assay utilizes specific primers and probes provided with the amplification mix…

MFG/MD/2018/000029
Creatine Kinase MB · Class BMFG · 2025-11-07

This immunoassay is designed for the in vitro quantitative determination of creatine kinase MB (CK-MB) isoenzyme levels in human serum and plasma. The assay results are intended to aid healthcare professionals in the diagnosis and managemen…

MFG/MD/2018/000022 · Gujarat
Troponin I · Class CMFG · 2025-11-04

Immunoassay for in vitro quantitative determination of Cardiac Troponin I in human serum and plasma.

MFG/MD/2018/000029
High-Sensitivity Troponin T STAT (hs-cTnT STAT) · Class CMFG · 2025-11-04

Immunoassay for in vitro quantitative determination of cardiac troponin T in human Serum and plasma. This assay is intended to auxiliary diagnosis of cardial infarction.

MFG/MD/2018/000029
N-terminal pro B-type Natriuretic Peptide · Class CMFG · 2025-11-04

Immunoassay for the in vitro quantitative determination of N-terminal pro B-type natriuretic peptide in human plasma.

MFG/MD/2018/000029
D-Dimer STAT · Class CMFG · 2025-11-04

Immunoassay for in vitro quantitative determination of D-Dimer in human plasma which is mainly used for the elimination of venous thrombosis, the auxillary diagnosis of disseminated intravascular coagulation and the monitoring of thrombolyt…

MFG/MD/2018/000029
LH Lyse · Class BIMPORT · 2025-10-29

This product is used to dissolve RBC and maintain the morphology of the cells needed to be analyzed before blood cell analysis therapy facillates cell sorting or HGB quantification.

IMP/IVD/2025/000148 · from China
Probe Cleanser · Class BIMPORT · 2025-10-29

This product can regularly remove the cell residues, blood proteins in the instrument to prevent protein precipitation in the sampling needle, pipe, counting chamber and prolong the life of the machine and assure the accuracy of the test.

IMP/IVD/2025/000148 · from China
DIFF Lyse · Class BIMPORT · 2025-10-29

This product is used to dissolve RBC and maintain the morphology of the cells needed to be analyzed before blood cell analysis sp that facillate cell sorting or HGB quantification.

IMP/IVD/2025/000148 · from China
LD Lyse · Class BIMPORT · 2025-10-29

This product is used to dissolve RBC and maintain the morphology of the cells needed to be analyzed before blood cell analysis so that facillate cell sorting or HGB quantification

IMP/IVD/2025/000148 · from China
Auto Hematology Analyzer · Class AMFG · 2025-10-28

The Auto Hematology Analyzer is a quantitative, automated hematology analyzer for In Vitro Diagnostic Use in clinical laboratories; it provides Complete Blood Count, Leukocyte Differential, Hemoglobin Concentration Measurement, Reticulocyte…

MFG/IVD/2025/000106 · Gujarat
Urine Adulteration Test · Class BMFG · 2025-10-28

The MERISCREEN Urine Adulteration Test is intended for a qualitative & semi-quantitative immunoassay to detect the presence of Leukocyte, Urobilinogen, Microalbumin, Protein, Bilirubin, Glucose, Ascorbate, Specific Gravity, Ketone Bodies, N…

MFG/MD/2018/000022 · Gujarat
Auto Hematology Analyzer · Class AMFG · 2025-10-28

The Auto Hematology Analyzer is a quantitative, automated hematology analyzer for In Vitro Diagnostic Use in clinical laboratories; it provides Complete Blood Count, Leukocyte 5-part Differential, Hemoglobin Concentration Measurement, Retic…

MFG/IVD/2025/000106 · Gujarat
Gene Analyzer · Class AMFG · 2025-10-21

The Sequencing System M10 is intended for sequencing of deoxyribonucleic acid (DNA) and Ribonucleic acid (RNA) from human clinical sample as peripheral whole blood or formalin-fixed paraffin-embedded (FFPE) tissue . These changes may lead t…

MFG/IVD/2025/000106 · Gujarat
Gene Analyzer · Class AMFG · 2025-10-21

The Sequencing System is intended for sequencing of deoxyribonucleic acid (DNA) and Ribonucleic aci d (RNA) from human clinical sample as peripheral whole blood or formalin-fixed, paraffin-embedded (FFPE) tissue . The GENEMAP M1 Sequencing …

MFG/IVD/2025/000106 · Gujarat
Transferrin Test Kit · Class BMFG · 2025-10-21

Transferrin kit is a medical device intended for the estimation of Transferrin in human serum and plasma.

MFG/MD/2018/000022 · Gujarat
Transferrin Test Kit · Class BMFG · 2025-10-21

Transferrin kit is a medical device intended for the estimation of Transferrin in human serum and plasma.

MFG/MD/2018/000022 · Gujarat
Gene Analyzer · Class AMFG · 2025-10-21

The product adopts the reversible terminator sequencing method, which is used to sequence deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) from human samples to detect genetic changes.

MFG/IVD/2025/000106 · Gujarat
Dengue IgG/IgM Antibody Detection Test · Class BMFG · 2025-10-21

Dengue IgG/ IgM Antibody test reagent/kit is a medical device intended for the detection of Dengue Antibody in blood/body fluids i.e human serum, plasma or whole blood.

MFG/MD/2018/000022 · Gujarat
Malaria Pf Ag (HRP II/pLDH) Test · Class CMFG · 2025-10-10

MERISCREEN? Malaria Pf Ag (HRP II/pLDH) test kit is an in-vitro diagnostic immunochromatographic assay for the qualitative detection of malaria infection by Plasmodium falciparum through P. falciparum-specific HRPII (Histidine-Rich Protein)…

MFG/MD/2018/000029
Hematology Analyzer · Class AMFG · 2025-08-29

It is an IVD device used in clinical laboratory for hemoglobin test, blood cell count & analysis, and leukocyte three-part classification count of human blood sample.

MFG/IVD/2025/000106 · Gujarat
Hematology Analyzer · Class AMFG · 2025-08-29

It is used for detecting the parameters of RBC, WBC, HGB and differential counter.The analyzer is used for the determination of the following 20 parameters and 3 histograms in blood

MFG/IVD/2025/000106 · Gujarat
Hematology Analyzer · Class AMFG · 2025-08-29

This Analyzer is intended for in vitro diagnostic use in clinical laboratories and designed for Quantitative determination of complete Blood cell in Human/Animal whole blood. The Machine can measure WBC, RBC, HGB, MCV & Platelet count in De…

MFG/IVD/2025/000106 · Gujarat
Hematology Analyzer · Class AMFG · 2025-08-29

It can count the number of red blood cells and platelets in blood sample with impedance method, test the hemoglobin concentration with colorimetric method, get the total number and have five-classification of the white blood cells with semi…

MFG/IVD/2025/000106 · Gujarat
Biochemistry Analyzer · Class AMFG · 2025-08-29

This analyzer is intended for in vitro diagnostic use in clinical laboratories and designed for quantitative determination of clinical chemistries in serum, plasma, urine and cerebrospinal fluid samples.

MFG/IVD/2025/000106 · Gujarat
Coagulation Analyzer · Class AMFG · 2025-08-29

The Clotquant 2 is designed to carry out coagulometric tests such as PT, APTT, FIB, TT and single factor tests.

MFG/IVD/2025/000106 · Gujarat
Biochemistry Analyzer · Class AMFG · 2025-08-29

The analyzer is an automated Biochemistry Analyser for in vitro diagnostic use in clinical laboratories and designed for in vitro quantitative determination of clinical chemistries in serum, plasma, urine or cerebrospinal fluid samples.

MFG/IVD/2025/000106 · Gujarat
Biochemistry Analyzer · Class AMFG · 2025-08-29

It is intended for in vitro diagnostic use and quantitative determination of clinical chemistries samples, such as serum, plasma, urine or cerebrospinal fluid

MFG/IVD/2025/000106 · Gujarat
Coagulation Analyzer · Class AMFG · 2025-08-29

Merilyzer ClotQuant 4 is designed to carry out coagulometric tests such as PT, APTT, FIB, TT and single factor tests. ClotQuant 4 must be operated by personnel trained in clinical laboratory techniques and operations of this instrument.

MFG/IVD/2025/000106 · Gujarat
HbA1c Analyzer · Class AMFG · 2025-08-29

It is an analyzer with Hemoglobin Alc Assay kit is used to detect the ratio of glycated hemoglobin to total Hemoglobin in the blood samples.

MFG/IVD/2025/000106 · Gujarat

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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