Vietnam MOH registration 240002230/PCBA-HN

IVD pha loãng dùng trong xét nghiệm huyết học

Vietnam·Risk Class TBYT Loại A·Theo theo phụ lục·B&E Bio-Technology Co., Ltd·Registered Oct 11, 2024

Registration details

Analysis ID: 240002230/PCBA-HN
Submission ID: 000.00.19.H26-241003-0001
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: B&E Bio-Technology Co., Ltd
Manufacturer Country: Theo theo phụ lục
Product Owner: B&E Bio-Technology Co., Ltd
Authorized Representative: CÔNG TY TNHH THIẾT BỊ CÔNG NGHỆ HKT

Technical details

Intended Use: Diluit-Sys-Retic is used to dilute blood samples for the counting of reticulocytes and the percentage of reticulocytes in the blood using the Sysmex R-500, XT, XE hematology analyzer series. Diluit-Sys-DCFL is used to dilute blood samples for the counting of reticulocytes, the percentage of reticulocytes, and the number of platelets in the blood using the Sysmex XN hematology analyzer series. Diluit-Sys-DCCL is used for the Sysmex XN hematology analyzer series as a dilution reagent and sheath fluid reagent for the full blood count test. Diluit-Sys is used for the TOA SYSMEX hematology analyzer as a reagent for diluting the whole blood sample. Diluit-MEK is used by the three-component automatic hematology analyzer MEK as a reagent for diluting the whole blood sample. Diluit-BC-68Retic is used to dilute blood samples for the counting of reticulocytes and the percentage of reticulocytes in the blood using the hematology analyzer BC-6800, BC-6600, BC-6900, BC-6700, BC6200, BC6000 Plus, BC6100 Plus, BC6600 Plus, BC6700 Plus, BC6800 Plus, BC7500, BC7300. Diluit-BC6 is used by the automatic hematology analyzer BC-5000, BC-5120, BC-5130, BC-5140, BC-5150, BC-5160, BC-5170, BC-6800, BC-6600, BC-6900, BC-6700, BC-6000, BC-6100, BC-6200, BC6000 Plus, BC6100 Plus, BC6600 Plus, BC6700 Plus, BC6800 Plus, BC7500, BC7300, CRP-M100 as a reagent for diluting the whole blood sample and as a sheath fluid reagent. Diluit--BC-5Diff is used by the automatic hematology analyzer BC-5500, BC-5800, BC-5600, BC-5200, BC-5300, BC-5380, BC-5310, BC-5390, BC-5100, BC-5180, BC-5390CRP, BC-5310CRP, BC-5180CRP, BC-5100CRP as a reagent for diluting the whole blood sample. Diluit-BC is used for the Mindray 3-component automatic hematology analyzer series as a reagent for diluting the whole blood sample. For in vitro diagnostic use only.

Dates and status

Registration Date: Oct 11, 2024

About this record

Access comprehensive regulatory information for IVD pha loãng dùng trong xét nghiệm huyết học in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại A medical device is registered under number 240002230/PCBA-HN and manufactured by B&E Bio-Technology Co., Ltd. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ CÔNG NGHỆ HKT.

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