Vietnam MOH registration 2403682ĐKLH/BYT-HTTB

Phenotypic Selection

VN: Phin lọc bạch cầu

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Haemonetics·Registered Nov 19, 2024

Registration details

Analysis ID: 2403682ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-211005-0009
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Haemonetics
Manufacturer Country: Theo theo phụ lục
Product Owner: Haemonetics
Authorized Representative: CÔNG TY TNHH TRANSMEDIC HEALTHCARE

Technical details

Intended Use: Highly efficient white blood cell filtration is prescribed to remove white blood cells and micro particles from the platelet pool in the intermediate layer (buffy coat). A compatible dye is attached to the Vacutainer blood collection tube to facilitate bacterial detection or other quality control (QC) methods. The ELX bag is suitable for storage of platelets at 22 ± 2 °C up to 7 days in a platelet shaker. It is sterilized by radiation. The drainage line is sterilized and free of pyrogens.

Dates and status

Registration Date: Nov 19, 2024

About this record

Access comprehensive regulatory information for Phenotypic Selection in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2403682ĐKLH/BYT-HTTB and manufactured by Haemonetics. The authorized representative in Vietnam is CÔNG TY TNHH TRANSMEDIC HEALTHCARE.

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