Importer / authorised agent · Tamil Nadu · India

Matrix Labs Pvt Ltd

CDSCO licensing intelligence, reconciled with the manufacturer’s global footprint · AI-reviewed · expert verification in progress — not yet independently verified.
CDSCO licences
536
Manufacturing
182
Import
354
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices36
Class BLow–moderate risk393
Class CModerate–high risk103
Class D (high risk)Highest-risk devices4

CDSCO device licences

Unsaturated Iron Binding Capacity (UIBC) Test Kit (Ferene Method) · Class BMFG · 2026-02-27

Unsaturated Iron Binding Capacity (UIBC) Test Kit (Ferene Method) is for the quantitative determination of UIBC in human serum or plasma. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Estradiol (E2) FIA Kit · Class BMFG · 2026-02-27

Estradiol (E2) fluorescence immunoassay is used for quantitative determination of Estradiol (E2) in human serum or plasma or whole blood. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Follicle Stimulating Hormone (FSH) FIA Kit · Class BMFG · 2026-02-27

Follicle Stimulating Hormone (FSH) fluorescence immunoassay is used for quantitative determination of Follicle Stimulating Hormone (FSH) in human serum or plasma or whole blood. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Filariasis Antibody (IgG) CLIA Kit · Class BMFG · 2026-02-27

The Filariasis Antibody (IgG) CLIA Kit is a chemiluminescent microparticle immunoassay (CLIA Microparticles) designed for the qualitative detection of Filarial antibodies to Wuchereria bancrofti, Brugia malayi and/or Brugia timori in human …

MFG/IVD/2025/000141 · Tamil Nadu
Free Triiodothyronine (FT3) FIA Kit · Class BMFG · 2026-02-27

Free Triiodothyronine (FT3) fluorescence immunoassay kit is used for quantitative determination of Free Triiodothyronine (FT3) in human serum or plasma or whole blood. The test is used as an aid to the assessment of thyroid function. The te…

MFG/IVD/2025/000141 · Tamil Nadu
Rheumatoid Factor (RF) Test Reagent Kit (Latex-Enhanced Immunoturbidimetry Method) · Class BMFG · 2026-02-27

Rheumatoid Factor (RF) Test Reagent Kit (Latex-Enhanced Immunoturbidimetry Method) is for the quantitative determination of Rheumatoid Factor (RF) in human serum. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Ferritin (Fer) FIA Kit · Class BMFG · 2026-02-27

Ferritin (Fer) fluorescence immunoassay is used for quantitative determination of Ferritin (Fer) in human serum or plasma or whole blood. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Fluorescence Immunoassay Analyzer · Class AMFG · 2026-02-27

The Fluorescence Immunoassay Analyzer is intended for the quantitative and qualitative detection of specific analytes in human samples (e.g., serum, plasma, or whole blood) using dry chemistry and immunofluorescence techniques. The device i…

MFG/IVD/2025/000141 · Tamil Nadu
Scrub Typhus IgM CLIA Kit · Class BMFG · 2026-02-27

The Scrub Typhus IgM CLIA Kit is a chemiluminescent microparticle immunoassay (CLIA Microparticles) designed for the qualitative detection of IgM antibodies to scrub typhus in human serum or plasma. The test kit is intended for professional…

MFG/IVD/2025/000141 · Tamil Nadu
Total IgE FIA Kit · Class BMFG · 2026-02-27

Total IgE fluorescence immunoassay is used for quantitative determination of Total IgE in human serum or plasma or whole blood. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Prolactin (PRL) FIA Kit · Class BMFG · 2026-02-27

Prolactin (PRL) fluorescence immunoassay is used for quantitative determination of Prolactin (PRL) in human serum or plasma or whole blood. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Thyroid Stimulating Hormone (TSH) FIA Kit · Class BMFG · 2026-02-27

Thyroid Stimulating Hormone (TSH) fluorescence immunoassay kit is used for quantitative determination of Thyroid Stimulating Hormone (TSH) in human serum or plasma or whole blood. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Lithium Test Kit (Phosphatase Method) · Class BMFG · 2026-02-27

Lithium Test Kit (Phosphatase Method) is for the quantitative determination of Lithium in human serum. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Free Thyroxine (FT4) FIA Kit · Class BMFG · 2026-02-27

Free Thyroxine (FT4) fluorescence immunoassay kit is used for quantitative determination of Free Thyroxine (FT4) in human serum or plasma or whole blood. The test is used as an aid to the assessment of thyroid function. The test kit is inte…

MFG/IVD/2025/000141 · Tamil Nadu
Progesterone (Prog) FIA Kit · Class BMFG · 2026-02-27

Progesterone (Prog) fluorescence immunoassay is used for quantitative determination of Progesterone (Prog) in human serum or plasma or whole blood. The kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Testosterone (TES) FIA Kit · Class BMFG · 2026-02-27

Testosterone (TES) fluorescence immunoassay kit is used for quantitative determination of testosterone (TES) in human serum or plasma or whole blood. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Hemoglobin A1c (HbA1C) FIA Kit · Class BMFG · 2026-02-27

Hemoglobin A1c (HbA1C) FIA Kit is used for quantitative determination of Hemoglobin A1c (HbA1C) in human whole blood sample. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
25-Hydroxy Vitamin D (25-OH-VD) FIA Kit · Class BMFG · 2026-02-27

25-Hydroxy Vitamin D (25-OH-VD) fluorescence immunoassay kit is used for quantitative determination of 25-Hydroxy Vitamin D (25-OH-VD) in human serum or plasma or whole blood. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Luteinizing Hormone (LH) FIA Kit · Class BMFG · 2026-02-27

Luteinizing Hormone (LH) fluorescence immunoassay is used for quantitative determination of Luteinizing Hormone (LH) in human serum or plasma or whole blood. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Magnesium Test Kit (Colorimetric Method) · Class BMFG · 2026-02-19

Magnesium Test Kit (Colorimetric Method) is for the quantitative determination of magnesium in human serum or plasma. The test kit is intended for professional use only

MFG/IVD/2025/000141 · Tamil Nadu
Creatinine Test Reagent Kit (Enzymatic Method) · Class BMFG · 2026-02-19

Creatinine Test Reagent Kit (Enzymatic Method) is for the quantitative determination of creatinine in human serum or plasma. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Glucose Test Kit (GOD-POD Method) · Class BMFG · 2026-02-19

Glucose Test Kit (GOD-POD Method) is for the quantitative determination of glucose in human serum or plasma. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Low-Density Lipoprotein (LDL) Test Reagent Kit (Direct Clearance Method) · Class BMFG · 2026-02-19

Low-Density Lipoprotein (LDL) Test Reagent Kit (Direct Clearance Method) is for the in vitro quantitative determination of LDL Cholesterol in human serum or plasma. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Total Bile Acids Test Reagent Kit (Enzyme Cycling Method) · Class BMFG · 2026-02-19

Total Bile Acids Test Reagent Kit (Enzyme Cycling Method) is for the quantitative determination of total bile acids in human serum or plasma. The test kit is intended for professional use only

MFG/IVD/2025/000141 · Tamil Nadu
Phosphorus Test Kit (Phosphomolybdate UV Method) · Class BMFG · 2026-02-19

Phosphorus Test Kit (Phosphomolybdate UV Method) is for the quantitative determination of phosphorus in human serum or plasma. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Anti-Streptolysin O (ASO) Test Reagent Kit (Latex-Enhanced Immunoturbidimetry Method) · Class BMFG · 2026-02-19

Anti-Streptolysin O (ASO) Test Reagent Kit (Latex-Enhanced Immunoturbidimetry Method) is for the quantitative determination of ASO in human serum. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Zinc Test Kit (Nitro-PAPS Method) · Class BMFG · 2026-02-19

Zinc Test Kit (Nitro-PAPS Method) is for the quantitative determination of Zinc in human serum or plasma. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Microalbumin (?ALB) Test Reagent Kit (Immunoturbidimetry Method) · Class BMFG · 2026-02-19

Microalbumin (?ALB) Test Reagent Kit (Immunoturbidimetry Method) is for the quantitative determination of µALB in human urine. The test kit is intended for professional use only

MFG/IVD/2025/000141 · Tamil Nadu
Copper Test Kit (PAESA Method) · Class BMFG · 2026-02-19

Copper Test Kit (PAESA Method) is for the quantitative determination of Copper in human serum or plasma. The test kit is intended for professional use only

MFG/IVD/2025/000141 · Tamil Nadu
Cholinesterase Test Reagent Kit (Butyrylthiocholine Method) · Class BMFG · 2026-02-19

Cholinesterase Test Reagent Kit (Butyrylthiocholine Method) is for the quantitative determination of Cholinesterase in human serum or plasma. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Clinical Chemistry Analyzer (Semi-Automated) · Class AMFG · 2026-01-28

MCA-11 Plus Clinical Chemistry Analyzer is intended to be used for the quantitative and / or qualitative determination of one or multiple clinical chemistry analytes in clinical specimen. Analyzer is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
High-Density Lipoprotein (HDL) Cholesterol Test Reagent Kit · Class BMFG · 2026-01-07

High-Density Lipoprotein (HDL) Cholesterol Test Reagent Kit is for the quantitative determination of HDL Cholesterol in human serum or plasma. The test kit is intended for professional use only

MFG/IVD/2025/000141 · Tamil Nadu
Albumin Test Kit (BCG Method) · Class BMFG · 2026-01-07

Albumin Test Kit (BCG Method) is for the quantitative determination of albumin in human serum or plasma. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Amylase Test Reagent (pNP-Maltotrioside Substrate Method) · Class BMFG · 2026-01-07

Amylase Test Reagent (pNP-Maltotrioside Substrate Method) is for the quantitative determination of amylase in human serum or plasma. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Urea Test Kit (Urease-GLDH UV Kinetic) · Class BMFG · 2026-01-07

Urea Test Kit (Urease-GLDH UV Kinetic) is for the quantitative determination of urea in human serum or plasma. The test kit is intended for professional use only

MFG/IVD/2025/000141 · Tamil Nadu
Gamma Glutamyl Transferase Test Reagent Kit · Class BMFG · 2026-01-07

Gamma Glutamyl Transferase Test Reagent Kit is for the quantitative determination of Gamma GT in human serum. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Total Protein Test Kit (Biuret Method) · Class BMFG · 2026-01-07

Total Protein Test Kit (Biuret Method) is for the quantitative determination of total protein in human serum or plasma. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Bilirubin Total Test Reagent Kit (Diazo Method) · Class BMFG · 2026-01-07

Bilirubin Total Test Reagent Kit (Diazo Method) is for the quantitative determination of bilirubin total in human serum or plasma. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Alkaline Phosphatase (ALP) Test Reagent Kit (IFCC Method) · Class BMFG · 2026-01-07

Alkaline Phosphatase (ALP) Test Reagent Kit (IFCC Method) is for the quantitative determination of alkaline phosphatase in human serum or plasma. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Creatinine Test Kit (Alkaline Picrate Method) · Class BMFG · 2026-01-07

Creatinine Test Kit (Alkaline Picrate Method) is for the quantitative determination of creatinine in human serum or plasma. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Creatinine Test Kit (Dry Chemistry) · Class BMFG · 2026-01-07

Creatinine Test Kit (Dry Chemistry) is used for quantitative determination of creatinine in human whole blood (venous or capillary blood), Serum and plasma samples. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Dry Chemistry Analyzer · Class AMFG · 2026-01-07

The Dry Chemistry Analyzer is intended for the quantitative and qualitative detection of specific analytes in human samples using dry chemistry technique. This device is for professional in vitro diagnostic use only.

MFG/IVD/2025/000141 · Tamil Nadu
Triglycerides Test Kit (GPO-POD Method) · Class BMFG · 2026-01-07

Triglycerides Test Kit (GPO-POD Method) is for the quantitative determination of triglycerides in human serum or plasma. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Uric Acid Test Kit (Uricase-POD Method) · Class BMFG · 2026-01-07

Uric Acid Test Kit (Uricase-POD Method) is for the quantitative determination of uric acid in human serum or plasma. The test kit is intended for professional use only

MFG/IVD/2025/000141 · Tamil Nadu
Bicarbonate Test Kit (PEPC Method) · Class BMFG · 2026-01-07

Bicarbonate Test Kit (PEPC Method) is for the quantitative determination of bicarbonate in human serum or plasma. The test kit is intended for professional use only

MFG/IVD/2025/000141 · Tamil Nadu
Calcium Test Kit (Arsenazo III Method) · Class BMFG · 2026-01-07

Calcium Test Kit (Arsenazo III Method) is for the quantitative determination of calcium in human serum or plasma. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Lactate Dehydrogenase (LDH) Test Reagent Kit (Pyruvate to Lactate UV Kinetic) · Class BMFG · 2026-01-07

Lactate Dehydrogenase (LDH) Test Reagent Kit (Pyruvate to Lactate UV Kinetic) is for the quantitative determination of lactate dehydrogenase in human serum. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Aspartate Amino Transferase (AST/SGOT) Test Reagent Kit (IFCC Method) · Class BMFG · 2026-01-07

Aspartate Amino Transferase (AST/SGOT) Test Reagent Kit (IFCC Method) is for the quantitative determination of AST/SGOT in human serum or plasma. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Total Cholesterol Test Kit (CHOD-POD Method) · Class BMFG · 2026-01-07

Total Cholesterol Test Kit (CHOD-POD Method) is for the quantitative determination of cholesterol in human serum or plasma. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu
Alanine Amino Transferase (ALT/SGPT) Test Reagent Kit (IFCC Method) · Class BMFG · 2026-01-07

Alanine Amino Transferase (ALT/SGPT) Test Reagent Kit (IFCC Method) is for the quantitative determination of ALT/SGPT in human serum or plasma. The test kit is intended for professional use only.

MFG/IVD/2025/000141 · Tamil Nadu

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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