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Calibration Standard for Quantitative Analysis of 8 Biochemical Indices - Vietnam Registration 240000042/PCBB-BYT

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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240000042/PCBB-BYT
Registration Details
Vietnam MOH Registration: 240000042/PCBB-BYT
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Device Details

Calibration Standard for Quantitative Analysis of 8 Biochemical Indices
VN: Chất hiệu chuẩn xét nghiệm định lượng 8 chỉ số sinh hóa
Risk Class TTBYT Loại B

Registration Details

240000042/PCBB-BYT

000.00.04.G18-240319-0005

VITROS Chemistry Products Calibrator Kit 3

1290709

Company Information

New York 14606

Ortho-Clinical Diagnostics, Inc.

Technical Details

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

Mar 20, 2024