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i-STAT PT/INR Cartridge - India CDSCO Medical Device Registration

i-STAT PT/INR Cartridge is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000018_fe331790f0619fdec2653fb6b077bfda_b6723b122914d9bf7f097386c8d14d30. This device is marketed under the brand name i-STAT PT/INR Cartridge. The license holder is CRESCENT ORGANICS PVT LTD, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
i-STAT PT/INR Cartridge
UID: IMP/IVD/2020/000018_fe331790f0619fdec2653fb6b077bfda_b6723b122914d9bf7f097386c8d14d30

Brand Name

i-STAT PT/INR Cartridge

Device Class

Class C

Approving Authority

CDSCO

Product Information

i-STAT PT, a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as coumadin or warfarin.,i-STAT CG8+ Cartridge(i-STAT PT/INR Cartridge)-The test for sodium, as part of the i-STAT System is intended for use in the in vitro quantification of sodium potassium, glucose, hematocrit, PO2, ionized calcium, pH, PCO2, TCO2 in arterial, venous or capillary whole blood.,i-STAT CG4+ Cartridge(i-STAT PT/INR Cartridge)-The test for sodium, as part of the i-STAT System, is intended for use in the in vitro quantification of PO2, pH, PCO2, TCO2, lactate in arterial or venous whole blood.,i-STAT Total ฮฒ-hCG Cartridge(i-STAT PT/INR Cartridge)-The i-STATยฎ Total Beta human Chorionic Gonadotropin (i-STAT PT/INR Cartridge) test is an in vitro diagnostic test for the quantitative and qualitative determination of -hCG in venous whole blood or plasma samples using i-STAT1 Analyzer Systems. The test is intended to be used as an aid in the early detection of pregnancy and is for prescription use only.,i-STAT BNP Cartridge(i-STAT PT/INR Cartridge)-The i-STATยฎ BNP test is an in vitro diagnostic test for the quantitative measurement of B-type natriuretic peptide (i-STAT PT/INR Cartridge) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.,i-STAT Celiteยฎ ACT Cartridge(i-STAT PT/INR Cartridge)-i-STAT Celite Activated Clotting Time (i-STAT PT/INR Cartridge) test is an in vitro diagnostic test that uses fresh, whole blood and is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis and for monitoring anticoagulation therapy in patients undergoing medical procedures such as catheterization, cardiac surgery, surgery, organ transplant and dialysis.,i-STAT CK-MB Cartridge(i-STAT PT/INR Cartridge)-The i-STATยฎ CK-MB test is an in vitro diagnostic test for the quantitative measurement of creatine kinase MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of myocardial infarction (i-STAT PT/INR Cartridge).,i-STAT G3+ Cartridge(i-STAT PT/INR Cartridge)-The test for sodium, as part of the i-STAT System is intended for use in the in vitro quantification of PO2, pH, PCO2, TCO2 in arterial or venous whole blood.,i-STAT cTnI Cartridge(i-STAT PT/INR Cartridge)-The i-STATยฎ cardiac troponin I (i-STAT PT/INR Cartridge) test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I (i-STAT PT/INR Cartridge) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.,i-STAT 6+ Cartridge(i-STAT PT/INR Cartridge)-The test for sodium, as part of the i-STAT System is intended for use in the in vitro quantification of sodium potassium, chloride, (i-STAT PT/INR Cartridge) glucose, hematocrit, in arterial, venous or capillary whole blood,i-STAT CHEM8+ Cartridge(i-STAT PT/INR Cartridge)-The test for sodium, as part of the i-STAT System, is intended for use in the in vitro quantification of sodium, potassium, chloride (i-STAT PT/INR Cartridge), glucose, hemocrit, ionized calcium, TCO2, creatinine in arterial or venous whole blood.,i-STAT EC4+Cartridge(i-STAT PT/INR Cartridge)-The test for sodium, as part of the i-STAT System is intended for use in the in vitro quantification of sodium potassium, chloride, (i-STAT PT/INR Cartridge) glucose, hematocrit, in arterial, venous or capillary whole blood.,i-STAT EC8+ Cartridge(i-STAT PT/INR Cartridge)-The test for sodium, as part of the i-STAT System is intended for use in the in vitro quantification of sodium potassium, chloride, (i-STAT PT/INR Cartridge), glucose, hematocrit, pH, PCO2, TCO2 in arterial venous or capillary whole blood.,i-STAT Creatinine Cartridge(i-STAT PT/INR Cartridge)-The test for creatinine, as part of the i- STATยฎ System, is for the quantitative determina-tion of creatinine in whole blood on the i-STAT handheld.,i-STAT EG7+ Cartridge(i-STAT PT/INR Cartridge)-The test for sodium, as part of the i-STAT System is intended for use in the in vitro quantification of sodium potassium, hematocrit, PO2, ionized calcium, pH, PCO2, TCO2 in arterial, venous or capillary whole blood.,i-STAT EG6+ Cartridge(i-STAT PT/INR Cartridge)-The test for sodium, as part of the i-STAT System is intended for use in the in vitro quantification of sodium potassium, PO2, hematocrit, pH, PCO2, TCO2 in arterial venous or capillary whole blood.,i-STAT E3+ Cartridge(i-STAT PT/INR Cartridge)-The test for sodium, as part of the i-STAT System is intended for use in the in vitro quantification of sodium potassium, hematocrit in arterial, venous, or capillary whole blood.,i-STAT Kaolin ACT Cartridge(i-STAT PT/INR Cartridge)-i-STAT Kaolin Activated Clotting Time (i-STAT PT/INR Cartridge) test is an in vitro diagnostic test that uses fresh, whole blood to monitor high dose heparin anticoagulation frequently associated with cardiovascular surgery.

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