BIOGENIX INC. PVT. LTD.
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 54 |
| Class B | Low–moderate risk | 422 |
| Class C | Moderate–high risk | 23 |
| Class D (high risk) | Highest-risk devices | 4 |
CDSCO device licences
This test is for the quantitative determination of hemoglobin (Hb) and calculated hematocrit (Hct) in capillary and venous whole blood.
MFG/IVD/2020/000082 · Uttar PradeshFor detection of Chikungunya IgM virus in human serum and plasma
MFG/IVD/2020/000082 · Uttar PradeshThe Scrub Typhus Elisa kit for IgG Test is a qualitative ELISA for the detection of IgG antibodies to O. tsutsugamushi (OT) in serum.
MFG/IVD/2020/000082 · Uttar PradeshThe Scrub Typhus Elisa kit for IgM Test is a qualitative ELISA for the detection of IgM antibodies to O. tsutsugamushi (OT) in serum.
MFG/IVD/2020/000082 · Uttar PradeshFor detection of Dengue IgG/IgM virus in human serum and plasma
MFG/IVD/2020/000082 · Uttar PradeshFor detection of Typhoid IgG/IgM virus in human serum and plasma
MFG/IVD/2020/000082 · Uttar PradeshASO is a fluorescence Immunoassay for the quantitative determination of Anti Streptolysin O (ASO) in human serum / plasma. It is useful as an aid in management and monitoring of scarlet fever, rheumatic fever and post infectious glomerulone…
MFG/IVD/2020/000082 · Uttar PradeshHbA1c Card is a rapid and sensitive immunoassay for the quantitative determination of HbA1c (Glycated hemoglobin) in human whole blood with Analyzer. The test is used for routine monitoring of long term glycemic status in patient with diabe…
MFG/IVD/2020/000082 · Uttar PradeshAnti-CCP is fluorescence Immunoassay (FIA) for the qualitative or semi-quantitative determination of human IgG autoantibodies to cyclic citrullinated peptides (CCP) in human whole blood/serum/plasma. It is useful as an aid in the diagnosis …
MFG/IVD/2020/000082 · Uttar PradeshTSH Test Kit (Dry Fluorescence Immunoassay) is intended for in-vitro quantitative measurement of TSH (Thyroid stimulating hormone) in human serum and plasma.
MFG/IVD/2020/000082 · Uttar PradeshPRL is a fluorescence Immunoassay for the quantitative determination of PRL in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of hypothalamic-pituitary disorders.
MFG/IVD/2020/000082 · Uttar PradeshLH is fluorescence Immunoassay for the quantitative determination of Luteinizing hormone (LH) in human serum/plasma. It is useful as an aid in management and monitoring of determination of evaluating fertility issues, function of reproducti…
MFG/IVD/2020/000082 · Uttar PradeshDengue IgG/IgM is a fluorescence Immunoassay (FIA) for the qualitative determination of IgG/IgM antibodies against dengue virus in human whole blood/serum/plasma. It is useful as an aid in screening of Dengue virus infection.
MFG/IVD/2020/000082 · Uttar Pradesh?-HCG is fluorescence Immunoassay for the quantitative determination of ?-HCG in human whole blood/serum /plasma. It is useful as an aid in management and monitoring of beta human chorionic gonadotropin (?-hCG) level in human.
MFG/IVD/2020/000082 · Uttar PradeshBiogenix Brucella Antibody ELISA Kit are quantitative and qualitative tests for detection of antibodies in serum and plasma directed against Brucella species for sue in diagnostic procedures.
MFG/IVD/2020/000082 · Uttar PradeshTotal IgE is a fluorescence immunoassay (FIA) for the quantitative determination of total IgE in human whole blood/serum/ plasma. It is useful as an aid in diagnosis and management of allergic disease.
MFG/IVD/2020/000082 · Uttar PradeshThe Salmonella antibody ELISA kit is a specific and sensitive assay for the detection of Salmonella antibodies in chicken sera.
MFG/IVD/2020/000082 · Uttar PradeshAn analyzer intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen.
MFG/IVD/2020/000082 · Uttar PradeshThe Foot-and-mouth disease indirect ELISA Test kit is used for the detection of FMD antibody in animal serum samples.
MFG/IVD/2020/000082 · Uttar PradeshCanine Brucellosis antibody ELISA kit is for the qualitative detection of specific antibodies present in serum of dogs, other animals and in humans with clinical symptoms consistent with Canine brucellosis.
MFG/IVD/2020/000082 · Uttar PradeshBovine Leptospira Antibody Rapid Detection Test is a lateral flow Immuno chromatographic assay for the qualitative detection of Leptospira Specific antibodies in Serum or plasma. It is intended to be used as a screening test and as an aid i…
MFG/IVD/2020/000082 · Uttar PradeshVitamin D is a fluorescence Immunoassay (FIA) for the quantitative determination of total 25(OH)D2/D3 level in human serum/plasma. It is useful as an aid in management and monitoring of regulating the concentration of calcium and phosphate …
MFG/IVD/2020/000082 · Uttar PradeshT3 Test Kit (Dry Fluorescence Immunoassay) is intended for in-vitro quantitative measurement of total T3 (Triiodothyronine) in human serum and plasma under normal physiological conditions, total T3 only accounts for about 5% of thyroid horm…
MFG/IVD/2020/000082 · Uttar PradeshProgesterone is a fluorescence Immunoassay for the quantitative determination of progesterone in human serum/plasma. It is useful as an aid in management and monitoring of the cause of infertility, track ovulation, diagnose an ectopic or fa…
MFG/IVD/2020/000082 · Uttar PradeshMyoglobin is fluorescence Immunoassay (FIA) for the quantitative determination of Myoglobin in human whole blood/ serum/plasma. It is useful as an aid in management and monitoring of acute myocardial infarction
MFG/IVD/2020/000082 · Uttar PradeshMicroalbumin is fluorescence Immunoassay for the quantitative determination of Microalbumin in human urine. It is useful as an aid in management and monitoring of determination of kidney damage from diabetes.
MFG/IVD/2020/000082 · Uttar PradeshFSH Plus is fluorescence Immunoassay (FIA) for the quantitative determination of FSH in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of concentration of FSH.
MFG/IVD/2020/000082 · Uttar PradeshFerritin is fluorescence Immunoassay (FIA) for the quantitative determination of Ferritin in human serum/plasma. It is useful as an aid for quantifying human ferritin.
MFG/IVD/2020/000082 · Uttar PradeshCortisol is fluorescence Immunoassay (FIA) for the quantitative determination of Cortisol in human whole blood/serum/ plasma. It is useful as an aid in management and monitoring of concentration of cortisol.
MFG/IVD/2020/000082 · Uttar PradeshCK-MB is Dry fluorescence Immunoassay for the quantitative determination of Creatine Kinase Isoenzyme-MB (CK-MB) in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of acute myocardiac infarction (AMI) and…
MFG/IVD/2020/000082 · Uttar PradeshAn analyzer intended to be used for the quantitative measurement of Glycated Haemoglobin (HbA1C) in a clinical specimen.
MFG/IVD/2020/000082 · Uttar PradeshThe Biogenix Mycobacterium avium subspecies paratuberculosis (MAP/paraTB) indirect ELISA kit is for the qualitative detection of specific antibodies present in serum of cattle, buffaloes, sheep, goat and camels with clinical symptoms consis…
MFG/IVD/2020/000082 · Uttar PradeshTestosterone is fluorescence Immunoassay for the quantitative determination of Testosterone in human serum/plasma. It is useful as an aid in management and monitoring of androgen level
MFG/IVD/2020/000082 · Uttar PradeshAMH Test Kit (Dry Fluorescence Immunoassay) is intended for in-vitro quantitative measurement of AMH (anti-mullerian hormone) in serum.AMH is a member of the transforming growth factor beta super family, which is a disaccharide protein comp…
MFG/IVD/2020/000082 · Uttar PradeshAn analyser intended to be used for the quantitative in vitro measurement of blood pH, partial pressure of oxygen (pO2) and /or partial pressure of carbon dioxide (pCO2), and the calculation of other blood gas parameters in a clinical speci…
MFG/IVD/2020/000082 · Uttar PradeshPPRV indirect ELISA kit is for the qualitative detection of specific antibodies present in serum of cattle, buffaloes, sheep, goat and humans Serum.
MFG/IVD/2020/000082 · Uttar PradeshHomocystein test reagent/kit is a medical device intended for the estimation of Homocystein in blood/body fluids.
MFG/IVD/2020/000082 · Uttar PradeshTheileria ELISA is for the qualitative detection of antibodies to Theileria in serum/Plasma as an aid in the clinical laboratory diagnosis of catteles with clinical symptoms consistent with leptospirosis.
MFG/IVD/2020/000082 · Uttar PradeshChikungunya IgM ELISA is designed for in vitro qualitative detection of Chikungunya IgM in human serum or plasma of collected blood samples suspected for Chikungunya.
MFG/IVD/2020/000082 · Uttar PradeshAn analyzer intended to be used for the qualitative and/or quantitative in vitro determination of microorganism growth in a blood culture preparation or other clinical specimen, with or without subsequent identification of the organism.
MFG/IVD/2020/000082 · Uttar PradeshThe Foot-and-mouth disease DIVA ELISA Test kit is used for the detection of FMD vaccinated and non-vaccinated animal serum samples with 3ABC antigen.
MFG/IVD/2020/000082 · Uttar PradeshCanine Leptospira ELISA is for the qualitative detection of antibodies to Canine leptospira in serum as an aid in the clinical laboratory diagnosis of dogs with clinical symptoms consistent with leptospirosis.
MFG/IVD/2020/000082 · Uttar PradeshThe Sickle cell test is a lateral flow chromatographic qualitative immunoassay to aid in the rapid diagnosis of sickle cell disorders of hemoglobins A, S, and C using fingerstick or venipuncture whole blood samples.
MFG/IVD/2020/000082 · Uttar PradeshThe Biogenix Bovine Tuberculosis ELISA is for the qualitative detection of antibodies to Bovine Tuberculosis in serum as an aid in the clinical laboratory diagnosis of cattles with clinical symptoms consistent with leptospirosis.
MFG/IVD/2020/000082 · Uttar PradeshThe Anthrax antibody ELISA kit is a specific and sensitive assay for the detection of Anthrax antibodies in sera.
MFG/IVD/2020/000082 · Uttar PradeshLH rapid test is an in-vitro immunochromatographic one step assay designed for qualitative determination of Luteinizing Hormone in urine to predict time of ovulation.
MFG/IVD/2020/000082 · Uttar PradeshTest for qualitative determination of sickling hemoglobin in whole blood by solubility test method
MFG/IVD/2020/000082 · Uttar PradeshT4 Test Kit (Dry Fluorescence Immunoassay) is intended for in-vitro quantitative measurement of total T4 (Thyroxine) in human serum and plasma under normal physical conditions. It can be used in the monitoring of hyperthyroidism and hypothy…
MFG/IVD/2020/000082 · Uttar PradeshRF IgM is a fluorescence Immunoassay for the quantitative determination of RF IgM in human whole blood / serum / plasma. It is useful as an aid in management and monitoring of rheumatoid arthritis.
MFG/IVD/2020/000082 · Uttar PradeshAn analyzer intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers, in a clinical specimen.
MFG/IVD/2020/000082 · Uttar PradeshGlobal 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.