Automated Urinalysis Machine
Vietnam·Risk Class TTBYT Loại B·iChem VELOCITY·Beckman Coulter, Inc.·Registered Sep 18, 2022- Analysis ID
- 220003018/PCBB-BYT
- Submission ID
- 000.00.04.G18-220918-0002
- Product Type
- iChem VELOCITY
- Manufacturer
- Beckman Coulter, Inc.
- Manufacturer Country
- USA
- Intended Use
- iChemVELOCITY is an in vitro diagnostic device that automates the biochemical urine analysis process using the iChemVELOCITY chemical test strip. iChemVELOCITY can be used as a stand-alone system or in combination with the iQ200 flow system, a proprietary configuration named iRICELL, as this system is designed to be both hardware and software compatible with the iQ200 flow system. The system provides quantitative results for specific gravity, semiquantitative results for glucose, blood, alkaline phosphatase, bilirubin, urobilinogen, pH, protein, ketones, and ascorbic acid; and qualitative results for nitrite, color, and turbidity. The iChemVELOCITY chemical test strip should be used only with the iChemVELOCITY analyzer. In other words, these test strips are not intended for visual inspection. The iChemVELOCITY chemical test strip is not intended for visual inspection. iChemVELOCITY should not be used as a point-of-care (POC) rapid analysis device. These measurements are used to support the diagnosis of metabolic disorders, abnormal kidney function, urinary tract infections, and liver dysfunction. The tests performed by iChemVELOCITY are intended only for in vitro diagnosis and clinical laboratory use.
- Registration Date
- Sep 18, 2022
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