Matrix Labs Pvt Ltd
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 36 |
| Class B | Low–moderate risk | 393 |
| Class C | Moderate–high risk | 103 |
| Class D (high risk) | Highest-risk devices | 4 |
CDSCO device licences
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 NaduEstradiol (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 NaduFollicle 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 NaduThe 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 NaduFree 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 NaduRheumatoid 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 NaduFerritin (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 NaduThe 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 NaduThe 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 NaduTotal 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 NaduProlactin (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 NaduThyroid 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 NaduLithium 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 NaduFree 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 NaduProgesterone (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 NaduTestosterone (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 NaduHemoglobin 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 Nadu25-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 NaduLuteinizing 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 NaduMagnesium 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 NaduCreatinine 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 NaduGlucose 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 NaduLow-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 NaduTotal 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 NaduPhosphorus 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 NaduAnti-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 NaduZinc 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 NaduMicroalbumin (?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 NaduCopper 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 NaduCholinesterase 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 NaduMCA-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 NaduHigh-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 NaduAlbumin 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 NaduAmylase 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 NaduUrea 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 NaduGamma 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 NaduTotal 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 NaduBilirubin 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 NaduAlkaline 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 NaduCreatinine 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 NaduCreatinine 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 NaduThe 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 NaduTriglycerides 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 NaduUric 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 NaduBicarbonate 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 NaduCalcium 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 NaduLactate 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 NaduAspartate 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 NaduTotal 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 NaduAlanine 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 NaduGlobal 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.