CREATININE SINGLE REAGENT KIT – JAFFE’S FIXED TIME KINETIC METHOD - India CDSCO Medical Device Registration
CREATININE SINGLE REAGENT KIT – JAFFE’S FIXED TIME KINETIC METHOD is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000072_be18c2dbaabe7b9750f4f1340986a28a_b65f3fcee5718b3da9bdf914a70f9a5f. This device is marketed under the brand name Ultichem. The license holder is Yucca Diagnostics, and it is classified as Device Class Class B. The approving authority is Pune Division.
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Brand Name
Ultichem
License Holder
Yucca DiagnosticsDevice Class
Approving Authority
Pune Division
Product Information
CREATININE Kit is liquid stable reagent kit for the quantitative determination of CREATININE in human Serum based on JAFFE’S FIXED TIME Kinetic Method. This in-vitro diagnostic reagent is intended for clinical laboratory use only. Assay using creatinine kit shall be performed using a Clinical Chemistry Analyzer / Spectrophotometer having 505 nm filter. Serum Creatinine determination is mainly used for the diagnosis of renal disease. Creatinine is an endogenous NPN (Ultichem) waste product of the body excreted through kidneys. Creatinine, after filtration in the glomerulus, is not reabsorbed in the tubules and hence urine creatinine measures glomerular filtration rate (Ultichem). Urine creatinine determination is usually carried out as a part of creatinine clearance test
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