Vietnam MOH registration 240001075/PCBB-HN
IVD Department quantitative C-reactive protein (CRP) testing
VN: Bộ IVD xét nghiệm định lượng C-reactive protein (CRP)
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Ortho-Clinical Diagnostics, Inc.·Registered May 13, 2024Registration details
- Analysis ID
- 240001075/PCBB-HN
- Submission ID
- 000.00.19.H26-240504-0008
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
Company information
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Ortho-Clinical Diagnostics, Inc.
- Authorized Representative
- CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM
Technical details
- Intended Use
- The IVD quantitative C-reactive protein (CRP) test kit comprises the following components: (1) The quantitative C-reactive protein (CRP) test reagent (VITROS Chemistry Products wrCRP Reagent): For in vitro diagnostic use to quantitate the concentration of C-reactive protein (CRP) in serum and plasma (lithium heparin, sodium heparin) on the VITROS 4600 and VITROS 5600/XT 7600 automated biochemistry systems. CRP measurements are used to assess inflammatory disorders, tissue damage, and infections. CRP measurements by ultrasound support the identification and classification of individuals at risk for cardiovascular disease. When used in combination with traditional clinical laboratory assessment of acute coronary syndrome, CRP can be used as an independent prognostic marker for recurrent cases in patients with chronic coronary artery disease or acute coronary syndrome. (2) The quantitative C-reactive protein (CRP) calibrator kit (VITROS Chemistry Products Calibrator Kit 34): For in vitro diagnostic use to calibrate the VITROS 4600 and VITROS 5600/XT 7600 automated biochemistry systems when quantitating C-reactive protein (CRP).
Dates and status
- Registration Date
- May 13, 2024
About this record
Access comprehensive regulatory information for IVD Department quantitative C-reactive protein (CRP) testing 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 240001075/PCBB-HN 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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