Vietnam MOH registration 240000043/PCBB-BYT

Calibration Standard for Quantitative Analysis of 7 Biochemical Indices

VN: Chất hiệu chuẩn xét nghiệm định lượng 7 chỉ số sinh hóa
Vietnam flagVietnam·Risk Class TTBYT Loại B·VITROS Chemistry Products Calibrator Kit 4·Ortho-Clinical Diagnostics, Inc.·Registered Mar 20, 2024
Registration details
Analysis ID
240000043/PCBB-BYT
Submission ID
000.00.04.G18-240320-0005
Product Type
VITROS Chemistry Products Calibrator Kit 4
Product Code
1204668
Company information
Manufacturer Country
New York 14606
Product Owner
Ortho-Clinical Diagnostics, Inc.
Technical details
Intended Use
Used in in vitro diagnostic to calibrate the VITROS 250/350/5,1 FS/4600 biochemical test system and the integrated VITROS 5600/XT 7600 system when quantifying Albumin, Conjugated Bilirubin and Unconjugated Bilirubin, Iron, Total Bilirubin, and Total Iron Binding Capacity (TIBC), Total Protein
Dates and status
Registration Date
Mar 20, 2024
About this record

Access comprehensive regulatory information for Calibration Standard for Quantitative Analysis of 7 Biochemical Indices 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 240000043/PCBB-BYT and manufactured by Ortho-Clinical Diagnostics, Inc.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM.

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