Vietnam MOH registration 240000984/PCBB-HCM

IVD Department quantitative iPTH testing

VN: Bộ IVD xét nghiệm định lượng iPTH

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Beckman Coulter, Inc.·Registered May 14, 2024

Registration details

Analysis ID: 240000984/PCBB-HCM
Submission ID: 000.00.19.H29-240321-0003
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Beckman Coulter, Inc.
Manufacturer Country: Theo theo phụ lục
Product Owner: Beckman Coulter, Inc.
Authorized Representative: VĂN PHÒNG ĐẠI DIỆN BECKMAN COULTER HONG KONG LIMITED TẠI TPHCM

Technical details

Intended Use: 1/ The quantitative iPTH test (Type: ACCESS INTACT PTH (iPTH)/Product Code: A16972): It is a fluorescent immunoassay, flow cytometric test to quantitate the levels of intact parathyrin (parathyrin, PTH) in human serum and plasma by the Access Immunoassay Systems. This test is intended to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia due to a malignancy, and can also be used in surgery. The test results should be used in conjunction with other clinical data to assist the physician in making individual patient management decisions. 2/ The quantitative iPTH test calibrators (Type: ACCESS INTACT PTH (iPTH) CALIBRATORS/ Product Code: A16953): They are used to calibrate the Access Intact PTH quantitative test to quantitate the levels of intact parathyrin (parathyrin, PTH) in human serum and plasma by the Access Immunoassay Systems.

Dates and status

Registration Date: May 14, 2024

About this record

Access comprehensive regulatory information for IVD Department quantitative iPTH 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 240000984/PCBB-HCM and manufactured by Beckman Coulter, Inc.. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN BECKMAN COULTER HONG KONG LIMITED TẠI TPHCM.

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