Vietnam MOH registration 240000516/PCBA-HN

Automated Immuno-histochemistry Testing Connectivity System

VN: Hệ thống kết nối xét nghiệm miễn dịch-sinh hóa tự động

Vietnam·Risk Class TTBYT Loại A·Power Link·IDS Co., Ltd.·Registered Mar 28, 2024

Registration details

Analysis ID: 240000516/PCBA-HN
Submission ID: 000.00.19.H26-240308-0005
Product Type: Power Link
Product Code: B05033

Company information

Manufacturer: IDS Co., Ltd.
Manufacturer Country: JAPAN
Product Owner: Beckman Coulter, Inc.
Authorized Representative: CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG

Technical details

Intended Use: Power Link is an automated sample processing system that includes the preparation and transport of the sample tubes to the Decapper Module, the DxI 600 or DxI 800 instrument, the AU680 or DxC 700 AU instrument, and then to the Outlet Racks for storage. The system helps reduce the risk of exposure to biological hazards for the laboratory staff. Power Link directly distributes the sample tubes to the module connected to the DxI and AU680 (or DxC 700 AU) instruments - at this point, the connection device will aspirate the sample into the instrument for analysis. After aspirating the sample, the system transports the tube to the Outlet Racks.

Dates and status

Registration Date: Mar 28, 2024

About this record

Access comprehensive regulatory information for Automated Immuno-histochemistry Testing Connectivity System in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại A medical device is registered under number 240000516/PCBA-HN and manufactured by IDS Co., Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG.

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