Genuine Biosystem Private Limited
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 25 |
| Class B | Low–moderate risk | 340 |
| Class C | Moderate–high risk | 59 |
| Class D (high risk) | Highest-risk devices | 30 |
CDSCO device licences
Clinical Chemistry Analyzer - (Semi-Automated) intended to be used for the qualitative and/or quantitative determination of one or multiple clinical chemistry parameters like (Glucose, Cholesterol, Triglycerides, Albumin, total protein, Cal…
MFG/IVD/2018/000004 · Tamil NaduIon-selective Analyser intended to be used for the quantitative measurement of electrolytes and/or other ions like Na+ (sodium), K+ (Potassium) Cl- (chloride), Calcium (Ca+), pH, Mg+ (magnesium), Lithium in human specimens like whole blood …
MFG/IVD/2018/000004 · Tamil NaduErythrocyte sedimentation rate (ESR) analyser is the medical device, intended for the quantitative measurement of sedimentation rate of human red blood cells.
MFG/IVD/2018/000004 · Tamil NaduFluorescent Immunoassay analyzer intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or of various biological markers like ASO, CRP. RF, microalbuminurea, hSCRP, IgE, D-Dimer, Ferritin, T3, T4,…
MFG/IVD/2018/000004 · Tamil NaduBlood Coagulation Analyzer intended to be used for the qualitative and/or of quantitative in vitro determination of one or multiple coagulation components involved in hemostasis like Prothrombin Time, partial thromboplastin, TT, Fibrinogen,…
MFG/IVD/2018/000004 · Tamil NaduNephelometry Immunoassay Analyser intended to be used for qualitative and/or quantitative in vitro determination of chemical and/or of various biological markers like ASO, CRP, RF, microlabuminurea, Hba1c, C3,C4,IgA, IgM,IgG, IgE, Anti-CCP,…
MFG/IVD/2018/000004 · Tamil NaduClinical Chemistry Analyzer - (Fully Automated) intended to be used for the qualitative and/or quantitative determination of one or multiple clinical chemistry parameters like (Glucose, Cholesterol, Triglycerides, Albumin, total protein, Ca…
MFG/IVD/2018/000004 · Tamil NaduHigh Performance Liquid Chromatography (HPLC) analyser is the medical device intended to use for quantitative analysis of HbA1C in human whole blood sample
MFG/IVD/2018/000004 · Tamil NaduChemiluminescent Immunoassay analyzer is the medical device, intended to use for Qualitative and or quantitative analysis of Invitro determination of chemical and/or biological makers like such as T3,T4, TSH, Free T3, Free T4, FSH, LH, Prol…
MFG/IVD/2018/000004 · Tamil NaduMicroplate Washer Automated intended to be used for washing microplates which is the one of the protocol to do washing as per various ELISA kits assay procotol like T3, T4, TSH, LH, progesterone, testerone, HIV, HBsAg, HCV, etc., in all of …
MFG/IVD/2018/000004 · Tamil NaduBlood Cell counter analyzer - (3- part differential) is a quantitative multiparameter automated hematology analyzer intended for Invitro diagnostic use in screening patient populations found in clinical laboratories. The parameters in whole…
MFG/IVD/2018/000004 · Tamil NaduEnzyme Immunoassay (EIA) analyser consists of holder for microplate 96 wells plates to record the absorbance/numerical values of microplates of various immunological assays like T3, T4, TSH, fT3, fT4, FSH, LH, Prolactin, progesterone, testo…
MFG/IVD/2018/000004 · Tamil NaduUrine Analyzer intended to be used for the qualitative and/or quantitative invitro determination of various chemical and cellular constituents like Glucose, ketone, protein, specific gravity, pH, Urobilinogen, Blood, Leukocytes, Bilirubin, …
MFG/IVD/2018/000004 · Tamil NaduBlood Cell counter analyzer - (5- part differential) is a quantitative multiparameter automated hematology analyzer intended for Invitro diagnostic use in screening patient populations found in clinical laboratories. The parameters in whole…
MFG/IVD/2018/000004 · Tamil NaduThe anti-neutrophil cytoplasmic antibodies (MPO) (P-ANCA) CLIA Test Kit is a chemiluminescent immunoassay (CLIA) for the quantitative in vitro detection of anti-myloperoxidase antibodies in human serum. anti-neutrophil cytoplasmic antibodie…
MFG/IVD/2018/000004 · Tamil NaduThe Myoglobin CLIA Test Kit is a chemiluminescent immunoassay (CLIA) for the quantitative in vitro detection of MYOGLOBIN in human serum.
MFG/IVD/2018/000004 · Tamil NaduThe Anti-Neutrophil Cytoplasmic Antibodies (PR3) (C-ANCA) CLIA Test Kit is a chemiluminescent immunoassay (CLIA) for the quantitative in vitro detection of anti-PR3 antibodies in human serum. ANTI-PR3 is to aid in the Wegener's granuloma (W…
MFG/IVD/2018/000004 · Tamil NaduThe Anti thyroid stimulating hormone receptor is a chemiluminescent immunoassay (CLIA) for the quantitative in vitro detection of antibody to thyrotropin receptor (Anti-TSHR) in human serum. ANTI TSHR determination is used as an aid in the …
MFG/IVD/2018/000004 · Tamil NaduThe IL-6 is a chemiluminescent immunoassay (CLIA) for the quantitative in vitro detection of Interleukin- 6 (IL-6) in human serum. This test is used in the monitoring of body?s immune status and inflammatory response. This test is intended …
MFG/IVD/2018/000004 · Tamil NaduThe CKMB CLIA Test kit is a chemiluminescent immunoassay (CLIA) for the quantitative in vitro detection of The MB Isoenzyme of Creatine Kinase (CK-MB) in human serum. This test is an aid in the diagnosis of myocardial infarction. This test …
MFG/IVD/2018/000004 · Tamil NaduThe Anti-cyclic Citrullinated peptide (CCP) Antibodies CLIA Test Kit is a chemiluminescent immunoassay (CLIA) for the quantitative in vitro detection of Anti-cyclic Citrullinated Peptide Antibody in human serum. This test is an aid in the d…
MFG/IVD/2018/000004 · Tamil NaduThe INSULIN CLIA TEST KIT is a chemiluminescent immunoassay (CLIA) for the quantitative in vitro detection of INSULIN in human serum.
MFG/IVD/2018/000004 · Tamil NaduAntithyroid Gland antibodies Test kit is a Medical Device for the screening of auto antibodies to Thyroid Gland antigens in human specimen. IMMUNOCHEMI Antithyroid gland antibodies CLIA Test Kit is a Chemiluminescent Microparticle Immunoass…
MFG/IVD/2018/000004 · Tamil NaduThe C-Peptide CLIA Test Kit is a chemiluminescent immunoassay (CLIA) for the quantitative in vitro detection of C PEPTIDE in human serum.
MFG/IVD/2018/000004 · Tamil NaduThe Parathyroid Hormone Test is a chemiluminescent immunoassay(CLIA) for the quantitative in vitro detection of Intact Parathyroid Hormone in human serum. This assay is intended to be used to aid in the differential diagnosis of hyperparath…
MFG/IVD/2018/000004 · Tamil NaduThe Estradiol Hormone CLIA Test Kit is a Chemiluminescent Immunoassay (CLIA) for the quantitative in vitro detection of E2 in human serum.
MFG/IVD/2018/000004 · Tamil NaduThe Ferritin CLIA Test Kit is a chemiluminescent immunoassay (CLIA)for the quantitative in vitro detection of FERRITIN in human serum.
MFG/IVD/2018/000004 · Tamil NaduTotal T3 (Triiodothyronine) TT3 CLIA test kit is the medical device, intended for the quantitative determination of Total T3 (Triiodothyronine) TT3 by chemiluminescence immunoassay (CLIA) method in human specimen.
MFG/IVD/2018/000004 · Tamil NaduFollicle Stimulating Hormone (FSH) CLIA test kit is the medical device intended for the quantitative determination of Follicle Stimulating Hormone (FSH) by chemiluminescent immunoassay (CLIA) method in human specimen
MFG/IVD/2018/000004 · Tamil NaduFree triiodothyronine (fT3) CLIA test kit is the medical device intended for the quantitative determination of Free triiodothyronine (fT3) by chemiluminescent immunoassay (CLIA) method in human specimen.
MFG/IVD/2018/000004 · Tamil NaduTotal T4 (Thyroxine) TT4 CLIA test kit is the medical device intended for the quantitative determination of Total T4 (Thyroxine) TT4 by chemiluminescence immunoassay (CLIA) method in human specimen.
MFG/IVD/2018/000004 · Tamil NaduProlactin CLIA test kit is the medical device intended for the quantitative determination of Prolactin by chemiluminescent immunoassay (CLIA) method in human specimen.
MFG/IVD/2018/000004 · Tamil NaduThyroid stimulating hormone (TSH) CLIA test kit is the medical device intended for the quantitative determination of Thyroid stimulating hormone by chemiluminescent immunoassay (CLIA) method in human specimen.
MFG/IVD/2018/000004 · Tamil NaduProgesterone CLIA test kit is the medical device intended for the quantitative determination of progesterone by chemiluminescent immunoassay (CLIA) method in human specimen.
MFG/IVD/2018/000004 · Tamil NaduTestosterone CLIA test kit is the medical device intended for the quantitative determination of Testosterone by chemiluminescent immunoassay (CLIA) method in human specimen.
MFG/IVD/2018/000004 · Tamil NaduLuteinizing Hormone (LH) CLIA test kit is the medical device intended for the quantitative determination of Luteinizing Hormone (LH) by chemiluminescent immunoassay (CLIA) method in human specimen.
MFG/IVD/2018/000004 · Tamil NaduFree T4 (Thyroxine) fT4 CLIA test kit is the medical device intended for the quantitative determination of Free T4 (Thyroxine) fT4 by chemiluminescent immunoassay (CLIA) method in human specimen.
MFG/IVD/2018/000004 · Tamil NaduAnti Mullerion hormone (AMH) CLIA test kit is the medical device intended for the quantitative determination of Anti Mullerion hormone (AMH) by chemiluminescent immunoassay (CLIA) method in human specimen.
MFG/IVD/2018/000004 · Tamil NaduVitamin D (25-OH Vitamin-D) CLIA test kit is the medical device intended for the quantitative determination of Vitamin D (25-OH Vitamin-D) by chemiluminescent immunoassay (CLIA) method in human specimen.
MFG/IVD/2018/000004 · Tamil NaduVitamin B12 CLIA test kit is the medical device intended for the quantitative determination of Vitamin B12 by chemiluminescent immunoassay (CLIA) method in human specimen.
MFG/IVD/2018/000004 · Tamil NaduAnti Thyroglobulin (Anti-TG) CLIA test kit is the medical device intended for the quantitative determination of Anti Thyroglobulin (Anti-TG) by chemiluminescent immunoassay (CLIA) method in human specimen.
MFG/IVD/2018/000004 · Tamil NaduAn AMH kit is a medical device, intended for the estimation of Anti Mullerion Hormone (AMH) in Serum
MFG/IVD/2018/000004 · Tamil NaduA Folate kit is a medical device, intended for the estimation of Folate in serum
MFG/IVD/2018/000004 · Tamil NaduA Chloride kit is a medical device, intended for the estimation of chloride in serum/urine
MFG/IVD/2018/000004 · Tamil NaduA CKNAC kit is a medical device, intended for the estimation of enzyme creatine kinase total (CKNAC) in serum
MFG/IVD/2018/000004 · Tamil NaduA Micro protein kit is a medical device, intended for the estimation of micro protein in urine
MFG/IVD/2018/000004 · Tamil NaduA C-Peptide kit is a medical device, intended for the estimation of C-peptide in serum
MFG/IVD/2018/000004 · Tamil NaduA potassium kit is a medical device, intended for the estimation of potassium in serum/urine
MFG/IVD/2018/000004 · Tamil NaduA sodium is a medical device, intended for the estimation of sodium in serum/urine
MFG/IVD/2018/000004 · Tamil NaduAn Urea kit is a medical device, intended for the estimation of Urea in Serum
MFG/IVD/2018/000004 · 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.