Vietnam MOH registration 240001646/PCBB-HN

Qualitative biochemical urine test control material

VN: Vật liệu kiểm soát xét nghiệm định tính sinh hoá nước tiểu

Vietnam·Risk Class TTBYT Loại B·UroColor Control·Abbott Diagnostics Korea Inc.·Registered Jul 09, 2024

Registration details

Analysis ID: 240001646/PCBB-HN
Submission ID: 000.00.19.H26-240313-0030
Product Type: UroColor Control
Product Code: 11UC11

Company information

Manufacturer: Abbott Diagnostics Korea Inc.
Product Owner: Abbott Diagnostics Korea Inc.
Authorized Representative: VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI

Technical details

Intended Use: 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

Registration Date: Jul 09, 2024

About this record

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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