Qualitative test kit for the detection of Y chromosome microdeletions in the AZF region: AZFa (sY84, sY86), AZFb (sY127, sY134), AZFc (sY254, sY255) in human - Vietnam Registration 240000010/PCBB-HCM
Access comprehensive regulatory information for Qualitative test kit for the detection of Y chromosome microdeletions in the AZF region: AZFa (sY84, sY86), AZFb (sY127, sY134), AZFc (sY254, sY255) in human 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 240000010/PCBB-HCM and manufactured by SACACE BIOTECHNOLOGIES Srl. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ KHOA HỌC KỸ THUẬT VIỆT HUY.
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Device Details
Registration Details
240000010/PCBB-HCM
000.00.19.H29-231227-0022
AZF System Y – chromosome
01200-50
Technical Details
The product is used to detect the presence of Y chromosome microdeletions in the AZF regions: AZFa (sY84, sY86), AZFb (sY127, sY134), AZFc (sY254, sY255) in men. This product is designed to be used as a support tool for the management of individuals affected by male infertility. The results of this test should not be used as the sole basis for diagnostic, therapeutic, or patient management decisions.
Dates and Status
Jan 02, 2024

