Vietnam MOH registration 220001349/PCBA-HCM

IVD Cleaning for Flow Cytometry Testing Machine

VN: IVD làm sạch dùng cho máy xét nghiệm tế bào dòng chảy

Vietnam·Risk Class TTBYT Loại A·Hypochlorite Solution·Sysmex Partec GmbH·Registered Jun 21, 2022

Registration details

Analysis ID: 220001349/PCBA-HCM
Submission ID: 000.00.19.H29-220607-0032
Product Type: Hypochlorite Solution
Product Code: 04-4019

Company information

Manufacturer: Sysmex Partec GmbH

Technical details

Intended Use: Hypochlorite Solution is used to clean the sample delivery tube by reducing the residual blood and/or protein that may be left from the previous sample measurement in the clinical flow cytometry cell counter Sysmex Partec. Hypochlorite Solution can be used immediately and loaded into the instrument through the sample port manually or through the automatic loading system. Hypochlorite solution is an auxiliary solution and does not provide any diagnostic information. Only laboratory technicians and FCM operators who have received proper training are permitted to handle Hypochlorite Solution.

Dates and status

Registration Date: Jun 21, 2022

About this record

Access comprehensive regulatory information for IVD Cleaning for Flow Cytometry Testing Machine 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 220001349/PCBA-HCM and manufactured by Sysmex Partec GmbH.

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