Vietnam MOH registration 240002231/PCBB-HCM

IVD Department quantitative prolactin testing

VN: Bộ IVD xét nghiệm định lượng prolactin

Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Registered Sep 30, 2024

Registration details

Analysis ID: 240002231/PCBB-HCM
Submission ID: 000.00.19.H29-240916-0001
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Authorized Representative: VĂN PHÒNG ĐẠI DIỆN LIFE TECHNOLOGIES HOLDINGS PTE. LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH

Technical details

Intended Use: *) 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

Registration Date: Sep 30, 2024

About this record

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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