IVD Department quantitative prolactin testing - Vietnam Registration 240002231/PCBB-HCM
Access comprehensive regulatory information for IVD Department quantitative prolactin testing in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002231/PCBB-HCM. 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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Device Details
Registration Details
240002231/PCBB-HCM
000.00.19.H29-240916-0001
Theo theo phụ lục
Theo phụ lục
Technical Details
*) B·R·A·H·M·S Prolactin KRYPTOR (Product Code: 824050N): The B·R·A·H·M·S Prolactin KRYPTOR test is an automated fluorescent immunoassay for the quantitative determination of prolactin concentration in serum and plasma (EDTA, heparin) of humans. The B·R·A·H·M·S Prolactin KRYPTOR test is indicated as a supportive tool to be used in combination with clinical assessment for the diagnosis of patients suspected of having hyperprolactinemia. *) B·R·A·H·M·S Prolactin KRYPTOR CAL (Product Code: 082491N): To calibrate the reference curve stored in the B·R·A·H·M·S KRYPTOR compact PLUS/ KRYPTOR GOLD. *) B·R·A·H·M·S HORMON1 KRYPTOR QC (Product Code: 087592N): To monitor the quality of the test on the B·R·A·H·M·S KRYPTOR compact PLUS/ KRYPTOR GOLD.
Dates and Status
Sep 30, 2024