Importer / authorised agent · Maharashtra · India

Tosoh India Pvt. Ltd.

CDSCO licensing intelligence, reconciled with the manufacturer’s global footprint · AI-reviewed · expert verification in progress — not yet independently verified.
CDSCO licences
1,087
Manufacturing
379
Import
708
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices17
Class BLow–moderate risk812
Class CModerate–high risk258
Class D (high risk)Highest-risk devices0

CDSCO device licences

Anti-Cyclic Citrullinated Peptides high sensitive (CCP hs) ELISA Kit · Class BMFG · 2026-01-21

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 Division
C-Peptide Enzyme Conjugate Reagent · Class BMFG · 2026-01-21

For 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 Division
Anti-Double Stranded DNA (dsDNA) Screen ELISA Kit · Class BMFG · 2026-01-21

For 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 Division
Anti-Thyroid Peroxidase (Anti-TPO) Enzyme Conjugate Reagent · Class BMFG · 2026-01-21

For 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 Division
Dehydroepiandrosterone Sulfate (DHEA-S) Calibrator Set · Class BMFG · 2026-01-21

For in-vitro diagnostic use only for the calibration of AccuBind Dehydroepiandrosterone Sulfate (DHEA-S) using Microplate Enzyme Immunoassay (ELISA)

MFG/IVD/2021/000039 · Kokan Division
Insulin Enzyme Conjugate Reagent · Class BMFG · 2026-01-21

For in-vitro diagnostic use only for quantitative determination of Insulin in Human Serum by a Microplate Enzyme Immunoassay (ELISA)

MFG/IVD/2021/000039 · Kokan Division
Beta Human Chorionic Gonadotropin (?HCG) ELISA Kit · Class BMFG · 2026-01-21

For the Quantitative Determination of Chorionic Gonadotropin (hCG) Concentration in Human Serum by a Microplate Immunoenzymometric assay

MFG/IVD/2021/000039 · Kokan Division
Anti-Phospholipid Screen IgG/IgM ELISA Kit · Class BMFG · 2026-01-21

For 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 Division
Human Growth Hormone (HGH) CLIA Kit · Class BMFG · 2026-01-21

For the Quantitative Determination of Growth Hormone Concentration in Human Serum by a Microplate Enzyme Immunoassay, Chemiluminescence

MFG/IVD/2021/000039 · Kokan Division
Thyroid (tT3+tT4+TSH) VAST CLIA Kit · Class BMFG · 2026-01-21

For 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 Division
Creatine Kinase (CK-MB) Enzyme Conjugate Reagent · Class BMFG · 2026-01-21

For 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 Division
Creatine Kinase (CK-MB) ELISA Kit · Class BMFG · 2026-01-21

For the Quantitative Determination of Circulating Creatinine Kinase (MB-Isoform) Concentrations in Human Serum by a Microplate Enzyme Immunoassay

MFG/IVD/2021/000039 · Kokan Division
Anti-Thyroglobulin (Anti-Tg) ELISA Kit · Class BMFG · 2026-01-21

For the quantitative determination of thyroglobulin (Tg) autoantibodies in human serum or plasma by a Microplate enzyme immunoassay

MFG/IVD/2021/000039 · Kokan Division
25-OH Vitamin D Total (Vit D-Direct) ELISA Kit · Class BMFG · 2026-01-21

For the Quantitative Determination of 25-OH Vitamin D Concentration in Human Serum by a Microplate Enzyme Immunoassay

MFG/IVD/2021/000039 · Kokan Division
Thyrotropin (TSH) Enzyme Conjugate Reagent · Class BMFG · 2026-01-21

For 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 Division
Free Testosterone CLIA Kit · Class BMFG · 2026-01-21

For the Quantitative Determination of Free Testosterone Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay, Chemiluminescence

MFG/IVD/2021/000039 · Kokan Division
Dehydroepiandrosterone Sulfate (DHEA-S) Tracer · Class BMFG · 2026-01-21

For 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 Division
Dehydroepiandrosterone Sulfate (DHEA-S) CLIA Kit · Class BMFG · 2026-01-21

For 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 Division
Free Thyroid (fT3+fT4+TSH) VAST ELISA Kit · Class BMFG · 2026-01-21

For 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 Division
Free Thyroxine (fT4) CLIA Kit · Class BMFG · 2026-01-21

For the Quantitative Determination of Free Thyroxine Concentration in Human Serum by a Microplate Chemiluminescence immunoassay (CLIA)

MFG/IVD/2021/000039 · Kokan Division
Unconjugated Estriol (u-E3) Calibrator Set · Class BMFG · 2026-01-21

For in-vitro diagnostic use only for the calibration of AccuLite Estriol using Microplate Enzyme Immunoassay, Chemiluminescence method

MFG/IVD/2021/000039 · Kokan Division
Vitamin B-12 (B12) CLIA Kit · Class BMFG · 2026-01-21

For the Quantitative Determination of Vitamin B12 Concentration in Human Serum by a Microplate Enzyme Immunoassay, Chemiluminescence

MFG/IVD/2021/000039 · Kokan Division
Estradiol (E2) Enzyme Conjugate Reagent · Class BMFG · 2026-01-21

For in-vitro diagnostic use only for quantitative determination of Estradiol in Human Serum by a Microplate Enzyme Immunoassay (ELISA)

MFG/IVD/2021/000039 · Kokan Division
Beta Human Chorionic Gonadotropin (?HCG) Enzyme Conjugate Reagent · Class BMFG · 2026-01-21

For 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 Division
Follicle Stimulating Hormone (FSH) ELISA Kit · Class BMFG · 2026-01-21

For the Quantitative Determination of Follicle Stimulating Hormone Concentration in Human Serum by a Microplate Immunoenzymometric assay (ELISA)

MFG/IVD/2021/000039 · Kokan Division
Creatine Kinase (CK-MB) Calibrator Set · Class BMFG · 2026-01-21

For in-vitro diagnostic use only for the calibration of AccuBind Creatinine Kinase (MB-Isoform) using Microplate Enzyme Immunoassay (ELISA)

MFG/IVD/2021/000039 · Kokan Division
Estradiol (E2) ELISA Kit · Class BMFG · 2026-01-21

For the Quantitative Determination of Estradiol Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay

MFG/IVD/2021/000039 · Kokan Division
Dehydroepiandrosterone Sulfate (DHEA-S) Enzyme Conjugate Reagent · Class BMFG · 2026-01-21

For 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 Division
Estradiol (E2) Calibrator Set · Class BMFG · 2026-01-21

For in-vitro diagnostic use only for the calibration of AccuBind Estradiol using Microplate Enzyme Immunoassay (ELISA)

MFG/IVD/2021/000039 · Kokan Division
Anti-Thyroglobulin (Anti-Tg) Calibrator Set · Class BMFG · 2026-01-21

For in-vitro diagnostic use only for the calibration of AccuBind Anti-Thyroglobulin (Anti-Tg) using Microplate Enzyme Immunoassay (ELISA)

MFG/IVD/2021/000039 · Kokan Division
Vitamin B-12 (B12) ELISA Kit · Class BMFG · 2026-01-21

For the Quantitative Determination of Vitamin B12 Concentration in Human Serum by a Microplate Enzyme Immunoassay

MFG/IVD/2021/000039 · Kokan Division
Immunoglobulin E (IgE) Calibrator Set · Class BMFG · 2026-01-21

for in-vitro diagnostic use only for the calibration of AccuBind Immunoglobulin E (IgE) using Microplate Enzyme Immunoassay (ELISA)

MFG/IVD/2021/000039 · Kokan Division
Anti-Thyroid Peroxidase (Anti-TPO) ELISA Kit · Class BMFG · 2026-01-21

For the Quantitative Determination of Thyroid Peroxidase (TPO) Autoantibodies in Human Serum or Plasma by a Microplate Enzyme Immunoassay

MFG/IVD/2021/000039 · Kokan Division
Free Testosterone ELISA Kit · Class BMFG · 2026-01-21

For the quantitative measurement of free testosterone in human serum by a Microplate enzyme immunoassay

MFG/IVD/2021/000039 · Kokan Division
25-OH Vitamin D Total (Vit D-Direct) CLIA Kit · Class BMFG · 2026-01-21

For the Quantitative Determination of 25-OH Vitamin D Concentration in Human Serum by Chemiluminescence Immunoassay (CLIA)

MFG/IVD/2021/000039 · Kokan Division
Immunoglobulin E (IgE) ELISA Kit · Class BMFG · 2026-01-21

For the Quantitative Determination of Immunoglobulin E (IgE) Concentration in Human Serum by a Microplate Enzyme Immunoassay

MFG/IVD/2021/000039 · Kokan Division
Immunoglobulin E (IgE) Enzyme Conjugate Reagent · Class BMFG · 2026-01-21

For 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 Division
Dehydroepiandrosterone Sulfate (DHEA-S) Calibrator Set · Class BMFG · 2026-01-21

For 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 Division
Human Growth Hormone (HGH) ELISA Kit · Class BMFG · 2026-01-21

For the Quantitative Determination of Growth Hormone Concentration in Human Serum by a Microplate Enzyme Immunoassay

MFG/IVD/2021/000039 · Kokan Division
Free Thyroxine (fT4) ELISA Kit · Class BMFG · 2026-01-21

For the Quantitative Determination of Free Thyroxine Concentration in Human Serum by a Microplate Enzyme Immunoassay

MFG/IVD/2021/000039 · Kokan Division
Free Thyroid (fT3+fT4+TSH) VAST CLIA Kit · Class BMFG · 2026-01-21

For 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 Division
Free Triiodothyronine (fT3) CLIA Kit · Class BMFG · 2026-01-21

For the Quantitative Determination of Free Triiodothyronine Concentration in Human Serum by a Microplate Chemiluminescence Immunoassay (CLIA)

MFG/IVD/2021/000039 · Kokan Division
Free Thyroxine (fT4) Calibrator Set · Class BMFG · 2026-01-21

For in-vitro diagnostic use only for the calibration of AccuBind Free T4 using Microplate Enzyme Immunoassay (ELISA)

MFG/IVD/2021/000039 · Kokan Division
Thyroid (tT3+tT4+TSH) Combi Calibrator Set · Class BMFG · 2026-01-21

For 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 Division
Unconjugated Estriol (u-E3) CLIA Kit · Class BMFG · 2026-01-21

For 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 Division
Unconjugated Estriol (u-E3) Tracer · Class BMFG · 2026-01-21

For 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 Division
Luteinizing Hormone (LH) Enzyme Conjugate Reagent · Class BMFG · 2026-01-21

For 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 Division
Follicle Stimulating Hormone (FSH) Enzyme Conjugate Reagent · Class BMFG · 2026-01-21

For 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 Division
Dehydroepiandrosterone Sulfate (DHEA-S) ELISA Kit · Class BMFG · 2026-01-21

For the Quantitative Determination of Dehydroepiandrosterone Sulfate Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay

MFG/IVD/2021/000039 · Kokan Division
Anti Tissue Transglutaminase IgA ELISA Kit · Class BMFG · 2026-01-21

For 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 Division

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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