Vietnam MOH registration 240000042/PCBB-BYT
Calibration Standard for Quantitative Analysis of 8 Biochemical Indices
VN: Chất hiệu chuẩn xét nghiệm định lượng 8 chỉ số sinh hóa
Vietnam·Risk Class TTBYT Loại B·VITROS Chemistry Products Calibrator Kit 3·Ortho-Clinical Diagnostics, Inc.·Registered Mar 20, 2024Registration details
- Analysis ID
- 240000042/PCBB-BYT
- Submission ID
- 000.00.04.G18-240319-0005
- Product Type
- VITROS Chemistry Products Calibrator Kit 3
- Product Code
- 1290709
Company information
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Manufacturer Country
- New York 14606
- Product Owner
- Ortho-Clinical Diagnostics, Inc.
- Authorized Representative
- CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM
Technical details
- Intended Use
- Used in in vitro diagnostic to calibrate the VITROS 250/350/5,1 FS/4600/ XT 3400 biochemical test system and the VITROS 5600/XT 7600 integrated system when quantifying ALT, ALKP, AMYL, AST, CK, GGT, LDH and LIPA
Dates and status
- Registration Date
- Mar 20, 2024
About this record
Access comprehensive regulatory information for Calibration Standard for Quantitative Analysis of 8 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 240000042/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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