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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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240000010/PCBB-HCM
Registration Details
Vietnam MOH Registration: 240000010/PCBB-HCM
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Device Details

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
VN: Bộ xét nghiệm định tính các vi mất đoạn trong các vùng AZF: AZFa (sY84, sY86), AZFb (sY127, sY134), AZFc (sY254, sY255) của nhiễm sắc thể Y ở người
Risk Class TTBYT Loại B

Registration Details

240000010/PCBB-HCM

000.00.19.H29-231227-0022

AZF System Y – chromosome

01200-50

Company Information

SACACE BIOTECHNOLOGIES Srl

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