Tosoh India Pvt. Ltd.
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 17 |
| Class B | Low–moderate risk | 812 |
| Class C | Moderate–high risk | 258 |
| Class D (high risk) | Highest-risk devices | 0 |
CDSCO device licences
For the Quantitative Determination of Concentration of IgG Class of Antibodies Against Cyclic Citrullinated Peptides (CCP) In Human Serum or Plasma
MFG/IVD/2021/000039 · Kokan DivisionFor in-vitro diagnostic use only for quantitative determination of C-Peptide in Human Serum by a Microplate Enzyme Immunoassay (ELISA)
MFG/IVD/2021/000039 · Kokan DivisionFor the quantitative measurement of IgG, IgM and IgA class autoantibodies against double-stranded DNA in human serum or plasma by an indirect solid phase enzyme immunoassay (ELISA)
MFG/IVD/2021/000039 · Kokan DivisionFor in-vitro diagnostic use only for quantitative determination of Anti-Thyroidperoxidase (Anti-TPO) in Human Serum by a Microplate Enzyme Immunoassay (ELISA)
MFG/IVD/2021/000039 · Kokan DivisionFor in-vitro diagnostic use only for the calibration of AccuBind Dehydroepiandrosterone Sulfate (DHEA-S) using Microplate Enzyme Immunoassay (ELISA)
MFG/IVD/2021/000039 · Kokan DivisionFor in-vitro diagnostic use only for quantitative determination of Insulin in Human Serum by a Microplate Enzyme Immunoassay (ELISA)
MFG/IVD/2021/000039 · Kokan DivisionFor the Quantitative Determination of Chorionic Gonadotropin (hCG) Concentration in Human Serum by a Microplate Immunoenzymometric assay
MFG/IVD/2021/000039 · Kokan DivisionFor screening the presence of IgG and IgM class autoantibodies against cardiolipin, phosphatidyl serine, phosphatidyl inositol, phosphatidic acid and beta-2-glycoprotein I in human serum or plasma by an Enzyme Immunoassay (ELISA)
MFG/IVD/2021/000039 · Kokan DivisionFor the Quantitative Determination of Growth Hormone Concentration in Human Serum by a Microplate Enzyme Immunoassay, Chemiluminescence
MFG/IVD/2021/000039 · Kokan DivisionFor the Quantitative Determination of Total Thyroxine; Total Triiodothyronine; Thyroid Stimulating Hormone Concentration for a comprehensive thyroid status of a Human Serum or Plasma sample by a Microplate Enzyme Immunoassay, Chemiluminesce…
MFG/IVD/2021/000039 · Kokan DivisionFor in-vitro diagnostic use only for quantitative determination of Creatinine Kinase (MB-Isoform) in Human Serum by a Microplate Enzyme Immunoassay (ELISA)
MFG/IVD/2021/000039 · Kokan DivisionFor the Quantitative Determination of Circulating Creatinine Kinase (MB-Isoform) Concentrations in Human Serum by a Microplate Enzyme Immunoassay
MFG/IVD/2021/000039 · Kokan DivisionFor the quantitative determination of thyroglobulin (Tg) autoantibodies in human serum or plasma by a Microplate enzyme immunoassay
MFG/IVD/2021/000039 · Kokan DivisionFor the Quantitative Determination of 25-OH Vitamin D Concentration in Human Serum by a Microplate Enzyme Immunoassay
MFG/IVD/2021/000039 · Kokan DivisionFor in-vitro diagnostic use only for quantitative determination of Thyrotropin (TSH) in Human Serum by a Microplate Enzyme Immunoassay (ELISA)
MFG/IVD/2021/000039 · Kokan DivisionFor the Quantitative Determination of Free Testosterone Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay, Chemiluminescence
MFG/IVD/2021/000039 · Kokan DivisionFor in-vitro diagnostic use only for quantitative determination of DHEA-S antibodies in Human Serum by a Microplate Enzyme Immunoassay, Chemiluminescence method
MFG/IVD/2021/000039 · Kokan DivisionFor the Quantitative Determination of Dehydroepiandrosterone Sulfate Concentration (DHEA-S) in Human Serum or Plasma by a Microplate Enzyme Immunoassay, Chemiluminescence
MFG/IVD/2021/000039 · Kokan DivisionFor the Quantitative Determination of Free Thyroxine; Free Triiodothyronine; Thyroid Stimulating Hormone Concentration for a comprehensive thyroid status of a Human Serum or Plasma sample by a Microplate Enzyme Immunoassay
MFG/IVD/2021/000039 · Kokan DivisionFor the Quantitative Determination of Free Thyroxine Concentration in Human Serum by a Microplate Chemiluminescence immunoassay (CLIA)
MFG/IVD/2021/000039 · Kokan DivisionFor in-vitro diagnostic use only for the calibration of AccuLite Estriol using Microplate Enzyme Immunoassay, Chemiluminescence method
MFG/IVD/2021/000039 · Kokan DivisionFor the Quantitative Determination of Vitamin B12 Concentration in Human Serum by a Microplate Enzyme Immunoassay, Chemiluminescence
MFG/IVD/2021/000039 · Kokan DivisionFor in-vitro diagnostic use only for quantitative determination of Estradiol in Human Serum by a Microplate Enzyme Immunoassay (ELISA)
MFG/IVD/2021/000039 · Kokan DivisionFor in-vitro diagnostic use only for quantitative determination of Chorionic Gonadotropin (hCG) in Human Serum by a Microplate Enzyme Immunoassay (ELISA)
MFG/IVD/2021/000039 · Kokan DivisionFor the Quantitative Determination of Follicle Stimulating Hormone Concentration in Human Serum by a Microplate Immunoenzymometric assay (ELISA)
MFG/IVD/2021/000039 · Kokan DivisionFor in-vitro diagnostic use only for the calibration of AccuBind Creatinine Kinase (MB-Isoform) using Microplate Enzyme Immunoassay (ELISA)
MFG/IVD/2021/000039 · Kokan DivisionFor the Quantitative Determination of Estradiol Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay
MFG/IVD/2021/000039 · Kokan DivisionFor in-vitro diagnostic use only for quantitative determination of DHEA-S in Human Serum by a Microplate Enzyme Immunoassay (ELISA)
MFG/IVD/2021/000039 · Kokan DivisionFor in-vitro diagnostic use only for the calibration of AccuBind Estradiol using Microplate Enzyme Immunoassay (ELISA)
MFG/IVD/2021/000039 · Kokan DivisionFor in-vitro diagnostic use only for the calibration of AccuBind Anti-Thyroglobulin (Anti-Tg) using Microplate Enzyme Immunoassay (ELISA)
MFG/IVD/2021/000039 · Kokan DivisionFor the Quantitative Determination of Vitamin B12 Concentration in Human Serum by a Microplate Enzyme Immunoassay
MFG/IVD/2021/000039 · Kokan Divisionfor in-vitro diagnostic use only for the calibration of AccuBind Immunoglobulin E (IgE) using Microplate Enzyme Immunoassay (ELISA)
MFG/IVD/2021/000039 · Kokan DivisionFor the Quantitative Determination of Thyroid Peroxidase (TPO) Autoantibodies in Human Serum or Plasma by a Microplate Enzyme Immunoassay
MFG/IVD/2021/000039 · Kokan DivisionFor the quantitative measurement of free testosterone in human serum by a Microplate enzyme immunoassay
MFG/IVD/2021/000039 · Kokan DivisionFor the Quantitative Determination of 25-OH Vitamin D Concentration in Human Serum by Chemiluminescence Immunoassay (CLIA)
MFG/IVD/2021/000039 · Kokan DivisionFor the Quantitative Determination of Immunoglobulin E (IgE) Concentration in Human Serum by a Microplate Enzyme Immunoassay
MFG/IVD/2021/000039 · Kokan DivisionFor in-vitro diagnostic use only for quantitative determination of Immunoglobulin E (IgE) in Human Serum by a Microplate Enzyme Immunoassay (ELISA)
MFG/IVD/2021/000039 · Kokan DivisionFor in-vitro diagnostic use only for the calibration of AccuLite Dehydroepiandrosterone Sulfate (DHEA-S) using Microplate Enzyme Immunoassay, Chemiluminescence method
MFG/IVD/2021/000039 · Kokan DivisionFor the Quantitative Determination of Growth Hormone Concentration in Human Serum by a Microplate Enzyme Immunoassay
MFG/IVD/2021/000039 · Kokan DivisionFor the Quantitative Determination of Free Thyroxine Concentration in Human Serum by a Microplate Enzyme Immunoassay
MFG/IVD/2021/000039 · Kokan DivisionFor the Quantitative Determination of Free Thyroxine; Free Triiodothyronine; Thyroid Stimulating Hormone Concentration for a comprehensive thyroid status of a Human Serum or Plasma sample by a Microplate Enzyme Immunoassay (CLIA)
MFG/IVD/2021/000039 · Kokan DivisionFor the Quantitative Determination of Free Triiodothyronine Concentration in Human Serum by a Microplate Chemiluminescence Immunoassay (CLIA)
MFG/IVD/2021/000039 · Kokan DivisionFor in-vitro diagnostic use only for the calibration of AccuBind Free T4 using Microplate Enzyme Immunoassay (ELISA)
MFG/IVD/2021/000039 · Kokan DivisionFor in-vitro diagnostic use only for the calibration of AccuLite Thyroid Combi (T3+T4+TSH) VAST kit for parameters such as T3, T4 & TSH Microplate Enzyme Immunoassay, Chemiluminescence method
MFG/IVD/2021/000039 · Kokan DivisionFor the Quantitative Determination of Free (unconjugated) Estriol (u-E3) Concentration in Human Serum or Plasma by a Microplate Chemiluminescence Immunoassay
MFG/IVD/2021/000039 · Kokan DivisionFor in-vitro diagnostic use only for quantitative determination of Free (unconjugated) Estriol (u-E3) in Human Serum by a Microplate Enzyme Immunoassay, Chemiluminescence method
MFG/IVD/2021/000039 · Kokan DivisionFor in-vitro diagnostic use only for quantitative determination of Luteinizing Hormone (LH) in Human Serum by a Microplate Enzyme Immunoassay (ELISA).
MFG/IVD/2021/000039 · Kokan DivisionFor in-vitro diagnostic use only for quantitative determination of Follitropin (FSH) in Human Serum by a Microplate Enzyme Immunoassay (ELISA)
MFG/IVD/2021/000039 · Kokan DivisionFor the Quantitative Determination of Dehydroepiandrosterone Sulfate Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay
MFG/IVD/2021/000039 · Kokan DivisionFor the quantitative measurement of IgA class autoantibodies against tissue Transglutaminase (tTG) in human serum or plasma by an indirect solid phase enzyme immunoassay (ELISA)
MFG/IVD/2021/000039 · Kokan DivisionGlobal 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.