IVD Kit for Urine Sediment Testing - Vietnam Registration 240001482/PCBB-HN
Access comprehensive regulatory information for IVD Kit for Urine Sediment Testing in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240001482/PCBB-HN and manufactured by Dirui Industrial Co., Ltd. The authorized representative in Vietnam is CÔNG TY TNHH THƯƠNG MẠI DỊCH VỤ TRÍ ĐỨC.
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Device Details
Registration Details
240001482/PCBB-HN
000.00.19.H26-240614-0024
Theo theo phụ lục
Theo phụ lục
Technical Details
Urine Sediment Analyzer Reagent Sheath: Used to coat the sample and form the diluted flow to count the physical components of urine Urine Sediment Analyzer Reagent Diluent: Used to dilute the sample Focus: Focus is used to determine the position of the focal plane of the microscope imaging system Positive Control: Used for quality control (QC) in the testing process Negative Control: Used for quality control (QC) in the testing process Standard Solution: Used to calibrate the urine sediment analyzer machine to ensure the accuracy of the test results.
Dates and Status
Jun 24, 2024