Vietnam MOH registration 240000944/PCBB-HCM

IVD Department for Quantitative sTfR Testing

VN: Bộ IVD xét nghiệm định lượng sTfR

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Beckman Coulter, Inc.·Registered May 06, 2024

Registration details

Analysis ID: 240000944/PCBB-HCM
Submission ID: 000.00.19.H29-240321-0006
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 sTfR Assay (Type: ACCESS sTfR/ Product Code: A32493): It is a fluorescent chemiluminescence immunoassay, based on the detection of the concentration of the circulating transferrin receptors (sTfR) in human serum and heparinized plasma by the Access Immunoassay System. This test is used to support the diagnosis of Iron Deficiency Anemia (IDA) and to differentiate IDA from Chronic Disease Anemia (CDA) with or without IDA. The test can also be used in combination with the ferritin measurement to calculate the sTfR/log ferritin index. This index is used to support the diagnosis of IDA and to differentiate CDA from IDA with or without CDA. 2/ The Quantitative sTfR Assay Calibration Standards (Type: ACCESS sTfR CALIBRATORS/ Product Code: A32494): Used to calibrate the Access sTfR Assay to determine the concentration of the circulating transferrin receptors in human serum and heparinized plasma by the Access Immunoassay System. 3/ The Level 1 Quality Control Material for the Quantitative sTfR Assay (Type: ACCESS sTfR QC1/ Product Code: B11056): Used to monitor the performance of the Access sTfR Assay of the system. 4/ The Level 2 and 3 Quality Control Materials for the Quantitative sTfR Assay (Type: ACCESS sTfR QC2 and QC3/ Product Code: B11057): Used to monitor the performance of the Access sTfR Assay of the system.

Dates and status

Registration Date: May 06, 2024

About this record

Access comprehensive regulatory information for IVD Department for Quantitative sTfR 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 240000944/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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