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ichroma™ ST2 - India CDSCO Medical Device Registration

ichroma™ ST2 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000059_64132f277f36ea6ccac1564cc5b637a0_a3bab4cfa778b8938d6fde66ac3fcee1. This device is marketed under the brand name ichroma™ ST2. The license holder is Kin Diagnostics, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered
Class Class B
ichroma™ ST2
UID: IMP/IVD/2020/000059_64132f277f36ea6ccac1564cc5b637a0_a3bab4cfa778b8938d6fde66ac3fcee1

Brand Name

ichroma™ ST2

License Holder

Kin Diagnostics

Device Class

Class B

Approving Authority

CDSCO

Product Information

ichroma™ ST2 is a fluorescence Immunoassay (ichroma™ ST2) for the quantitative soluble Suppressor of Tumorigenicity 2 (ichroma™ ST2) level in human whole blood/serum/plasma. It is useful as an aid in management and assessing the prognosis of patients diagnosed with chronic heart failure (ichroma™ ST2). ,ichroma™ Troponin T(ichroma™ ST2)-ichroma™ Troponin T is a fluorescence immunoassay (ichroma™ ST2) for the quantitative determination of cardiac Troponin T (ichroma™ ST2) level in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of acute myocardial infarction (ichroma™ ST2). ,ichroma™ Vitamin D Neo(ichroma™ ST2)-ichroma™ Vitamin D Neo is a fluorescence immunoassay (ichroma™ ST2) for the quantitative determination of total 25(ichroma™ ST2)D2/D3 level in human whole blood/serum/ plasma. It is useful as an aid in management and monitoring of regulating the concentration of calcium and phosphate in the bloodstream and promoting the healthy growth and remodeling of bone. ,ichroma™ HbA1c Neo(ichroma™ ST2)-ichroma™ HbA1c Neo is a fluorescence Immunoassay (ichroma™ ST2) for the quantitative determination of HbA1c (ichroma™ ST2) in human whole blood. It is useful as an aid in management and monitoring of the long-term glycemic status in patients with diabetes mellitus. ,ichroma™ TSH Plus(ichroma™ ST2)-ichroma™ TSH Plus is a fluorescence immunoassay (ichroma™ ST2) for the quantitative determination of TSH in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of measurement in the assessment of thyroid function. ,ichroma LH(ichroma™ ST2)-ichroma LH is a fluorescence Immunoassay (ichroma™ ST2) for the quantitative determination of Luteinizing hormone (ichroma™ ST2) in human serum/plasma. It is useful as an aid in management and monitoring of determination of evaluating fertility issues, function of reproductive organs (ichroma™ ST2), or detection of the ovulation. For in vitro diagnostic use only. ,ichroma Beta-hCG(ichroma™ ST2)-ichroma B-HCG is a fluorescence Immunoassay (ichroma™ ST2) for the quantitative determination of total Beta-hCG in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of total beta human chorionic gonadotropin (ichroma™ ST2) level in human. For in vitro diagnostic use only ,ichroma Cortisol(ichroma™ ST2)-"ichroma™ Cortisol is a fluorescence Immunoassay (ichroma™ ST2) 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. For in vitro diagnostic use only.",ichroma HbA1c(ichroma™ ST2)-ichroma HbA1c is a fluorescence Immunoassay (ichroma™ ST2) for the quantitative determination of HbA1c(ichroma™ ST2) in human whole blood. It is useful as an aid in management and monitoring of the long-term glycemic status in patients with diabetes mellitus. For in vitro diagnostic use only. ,ichroma Microalbumin(ichroma™ ST2)-ichroma Microalbumin is a fluorescence Immunoassay (ichroma™ ST2) 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. For in vitro diagnostic use only. ,ichroma Myoglobin(ichroma™ ST2)-ichroma Myoglobin is a fluorescence Immunoassay (ichroma™ ST2) 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 (ichroma™ ST2). For in vitro diagnostic use only. ,ichroma Cystatin C(ichroma™ ST2)-ichroma Cystatin C is a fluorescence Immunoassay (ichroma™ ST2) for the quantitative determination of cystatin C in human serum/plasma. It is useful as an aid in management and monitoring of renal disease. For in vitro diagnostic use only.,ichroma Ferritin(ichroma™ ST2)-ichroma Ferritin is a fluorescence Immunoassay (ichroma™ ST2) for the quantitative determination of Ferritin in human serum/plasma. It is useful as an aid in quantifies human ferritin. For in vitro diagnostic use only.,ichroma FSH(ichroma™ ST2)-ichroma FSH is a fluorescence Immunoassay (ichroma™ ST2) for the quantitative determination of follicle stimulating hormone(ichroma™ ST2) in human serum/ plasma.It is useful as an aid in management and monitoring of concentration of FSH. For in vitro diagnostic use only. ,ichroma Anti-CCP Plus(ichroma™ ST2)-"ichroma™ Anti-CCP is a fluorescence Immunoassay (ichroma™ ST2) for the qualitative or semi-quantitative determination of human IgG autoantibodies to cyclic citrullinated peptides (ichroma™ ST2) in human whole blood/serum/plasma. It is useful as an aid in the diagnosis of rheumatoid arthritis (ichroma™ ST2) in combination with other clinical and laboratory findings. For in vitro diagnostic use only.",ichroma CK-MB(ichroma™ ST2)-"ichroma™ CK-MB is a fluorescence Immunoassay (ichroma™ ST2) for the quantitative determination of Creatine Kinase Isoenzyme-MB (ichroma™ ST2) in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of acute myocardiac infarction (ichroma™ ST2) and acute coronary syndrome (ichroma™ ST2). For in vitro diagnostic use only.",ichroma PRL(ichroma™ ST2)-ichroma PRL is a fluorescence Immunoassay (ichroma™ ST2) for the quantitative determination of Prolactin (ichroma™ ST2) in human serum/plasma. It is useful as an aid in management and monitoring of hypothalamic-pituitary disorders. For in vitro diagnostic use only. ,ichroma Calprotectin(ichroma™ ST2)-"ichroma™ Calprotectin is a fluorescence Immunoassay (ichroma™ ST2) for quantitative determination of Calprotectin (ichroma™ ST2) in human feces. It is useful as an aid in management and monitoring of the reflex gastrointestinal inflammation caused by several pathologies (ichroma™ ST2). For in vitro diagnostic use only.",ichroma RF IgM(ichroma™ ST2)-ichroma RF IgM is a fluorescence Immunoassay (ichroma™ ST2) 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. For in vitro diagnostic use only. ,ichroma T4(ichroma™ ST2)-ichroma T4 is a fluorescence Immunoassay (ichroma™ ST2) for the quantitative determination of thyroxine (ichroma™ ST2) in human serum/plasma. It is useful as an aid in management and monitoring of thyroid disorder. For in vitro diagnostic use only. ,ichroma Testosterone(ichroma™ ST2)-ichroma Testosterone is a fluorescence Immunoassay (ichroma™ ST2) for the quantitative determination of Testosterone in human serum/plasma. It is useful as an aid in management and monitoring of androgen level. For in vitro diagnostic use only. ,ichroma Progesterone(ichroma™ ST2)-ichroma Progesterone is a fluorescence Immunoassay (ichroma™ ST2) 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 failing pregnancy, monitor the health of a pregnancy. For in vitro diagnostic use only. ,ichroma T3(ichroma™ ST2)-ichroma T3 is a fluorescence Immunoassay (ichroma™ ST2) for the quantitative determination of triiodothyronine (ichroma™ ST2) in human serum/plasma. It is useful as an aid in management and monitoring of determination of thyroid disorders. For in vitro diagnostic use only

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