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Qualitative biochemical urine test control material - Vietnam Registration 240001646/PCBB-HN

Access comprehensive regulatory information for Qualitative biochemical urine test control material 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 240001646/PCBB-HN and manufactured by Abbott Diagnostics Korea Inc.. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI.

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240001646/PCBB-HN
Registration Details
Vietnam MOH Registration: 240001646/PCBB-HN
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Device Details

Qualitative biochemical urine test control material
VN: Vật liệu kiểm soát xét nghiệm định tính sinh hoá nước tiểu
Risk Class TTBYT Loại B

Registration Details

240001646/PCBB-HN

000.00.19.H26-240313-0030

UroColor Control

11UC11

Company Information

Abbott Diagnostics Korea Inc.

Technical Details

UroColor Control is a quality control positive and negative control to analyze urine (Blood, Bilirubin, Urobilinogen, Ketone, Protein, Nitrite, Glucose, pH, Urine Specific Gravity, Leukocytes, Ascorbic Acid) The use of UroColor Control in the urine analysis quality control program aims to: - Determine whether UroColor and UroMeter are responding normally. - Confirm the capability of the user to perform the test correctly and interpret UroColor and UroMeter reliably. - Provide confidence in obtaining good results in routine urine analysis. - To develop proficiency in performing routine urine analysis in the laboratory from specimen processing through to result reporting

Dates and Status

Jul 09, 2024