The Supportive Diagnostic Test for Hypopharyngeal Cancer - Vietnam Registration 240001260/PCBB-HCM
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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Device Details
Registration Details
240001260/PCBB-HCM
000.00.19.H29-240310-0003
Theo theo phụ lục
Theo phụ lục
Technical Details
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
Jun 20, 2024