Vietnam MOH registration 240001260/PCBB-HCM

The Supportive Diagnostic Test for Hypopharyngeal Cancer

VN: Bộ xét nghiệm hỗ trợ chẩn đoán ung thư vòm họng

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·RESTALYST PTE LTD·Registered Jun 20, 2024

Registration details

Analysis ID: 240001260/PCBB-HCM
Submission ID: 000.00.19.H29-240310-0003
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: RESTALYST PTE LTD
Manufacturer Country: Theo theo phụ lục
Product Owner: RESTALYST PTE LTD
Authorized Representative: CÔNG TY TNHH ANDAMAN MEDICAL VIỆT NAM

Technical details

Intended Use: The ELISA NPC-REAAD EBV EA-IgA test (Detection of Nasopharyngeal Carcinoma by Recombinant Antigen-antibody) is designed to qualitatively and semi-quantitatively determine IgA antibodies in human serum and plasma. The test uses specific proteins of the Epstein-Barr virus (EBV) to aid in the diagnosis of Nasopharyngeal Carcinoma (NPC) by detecting the patient's EA IgA antibody response in serum and plasma samples.

Dates and status

Registration Date: Jun 20, 2024

About this record

Access comprehensive regulatory information for The Supportive Diagnostic Test for Hypopharyngeal Cancer 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 240001260/PCBB-HCM and manufactured by RESTALYST PTE LTD. The authorized representative in Vietnam is CÔNG TY TNHH ANDAMAN MEDICAL VIỆT NAM.

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