IVD Department quantitative procalcitonin testing
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Nov 19, 2024- Analysis ID
- 2403763ĐKLH/BYT-HTTB
- Submission ID
- 20011547/ĐKLH-BYT-TB-CT
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Authorized Representative
- VĂN PHÒNG ĐẠI DIỆN LIFE TECHNOLOGIES HOLDINGS PTE. LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH
- Intended Use
- *) Drug test for quantitative procalcitonin (B·R·A·H·M·S PCT sensitive KRYPTOR): The B·R·A·H·M·S PCT sensitive KRYPTOR test is an automated fluorescent immunoassay to determine the quantitative concentration of procalcitonin (PCT) in human serum or plasma (EDTA, heparin). PCT is a host response marker for bacterial infection. The B·R·A·H·M·S PCT sensitive KRYPTOR test is indicated as a support to be used in combination with clinical assessment to: •detect and differentiate clinically relevant infections, •assess the severity and prognosis of systemic, sepsis, severe sepsis and septic shock, •determine patients who benefit from antibiotic therapy, •monitor antibiotic therapy within the range of the test, •assess the success of antibiotic therapy in patients suspected or confirmed to have a bacterial infection. Note: The results of the B·R·A·H·M·S PCT sensitive KRYPTOR test must always be interpreted in the context of all the patient's test results and clinical assessment. *) Calibration standard for quantitative procalcitonin test (B·R·A·H·M·S PCT sensitive KRYPTOR CAL): to calibrate the stored calibration standard of the B·R·A·H·M·S KRYPTOR/ KRYPTOR compact/ KRYPTOR compact PLUS/ KRYPTOR GOLD instrument. *) Quality control material for quantitative procalcitonin test (B·R·A·H·M·S PCT sensitive KRYPTOR QC): quality control material for the B·R·A·H·M·S KRYPTOR/ KRYPTOR compact/ KRYPTOR compact PLUS/ KRYPTOR GOLD instrument.
- Registration Date
- Nov 19, 2024
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Access comprehensive regulatory information for IVD Department quantitative procalcitonin testing in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2403763ĐKLH/BYT-HTTB. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN LIFE TECHNOLOGIES HOLDINGS PTE. LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH.
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