Urinalysis Machine
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·Registered Jun 03, 2024- Analysis ID
- 240001123/PCBB-HCM
- Submission ID
- 000.00.19.H29-240527-0017
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Authorized Representative
- CÔNG TY TNHH Y TẾ MINDRAY VIỆT NAM
- Intended Use
- Urine analysis machine is an in vitro diagnostic device used to quantitatively analyze urine samples from humans in the laboratory environment. Clinically, the urine analysis machine determines and analyzes the components of human urine, including red blood cells, white blood cells, casts, bacteria, fungi, squamous epithelial cells, non-squamous epithelial cells, crystals, hyaline casts, unclassified casts, mucus, sperm, gram-positive and gram-negative bacteria, monohydrate calcium oxalate crystals, dihydrate calcium oxalate crystals, uric acid and triphosphate. The analyzer can also be used to qualitatively or semi-quantitatively analyze human urine samples using urine dipstick tests, which are suitable for routine clinical urinalysis. The analytical parameters include: white blood cells, nitrite, urobilinogen, protein, pH, red blood cells, urine specific gravity, ketones, bilirubin, glucose, Vitamin C, microalbumin, creatinine, calcium, color and turbidity.
- Registration Date
- Jun 03, 2024
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Access comprehensive regulatory information for Urinalysis Machine 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 240001123/PCBB-HCM and manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH Y TẾ MINDRAY VIỆT NAM.
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