Urine Analysis Machine
Vietnam·Risk Class TTBYT Loại B·Urilyzer 500 Pro·77 Elektronika Muszeripari Kft.·Registered Mar 13, 2022- Analysis ID
- 220001609/PCBB-BYT
- Submission ID
- 000.00.04.G18-220313-0001
- Product Type
- Urilyzer 500 Pro
- Product Code
- UL0500Pro
- Manufacturer
- 77 Elektronika Muszeripari Kft.
- Manufacturer Country
- Hungary
- Intended Use
- The Urilyzer 500 Pro is a desktop device designed for in vitro diagnosis using CombiScreen 11SYS Plus and CombiScreen 11SYS test strips produced by Analyticon Biotechnologies GmbH. The system performs semiquantitative detection of the following analytes in urine: Bilirubin, Urobilinogen, Ketones, Ascorbic Acid, Glucose, Protein (Albumin), Blood (Hemoglobin), pH, Nitrite, Leukocytes, and Specific Gravity. The Urilyzer 500 Pro is used in professional settings and centralized laboratory locations. The analyzer is designed to be used in screening at-risk patients to support diagnosis in the following areas: – Renal Function – Urinary Tract Infection – Metabolic Disorders – Carbohydrate Metabolism – Liver Function
- Registration Date
- Mar 13, 2022
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Access comprehensive regulatory information for Urine Analysis 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 220001609/PCBB-BYT and manufactured by 77 Elektronika Muszeripari Kft..
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