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Myeloperoxidase cell expression qualitative test drug - Vietnam Registration 240002446/PCBB-HCM

Access comprehensive regulatory information for Myeloperoxidase cell expression qualitative test drug in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002446/PCBB-HCM and manufactured by Agilent Technologies Denmark ApS. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ VÀ CÔNG NGHỆ LIFELABS.

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240002446/PCBB-HCM
Registration Details
Vietnam MOH Registration: 240002446/PCBB-HCM
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Device Details

Myeloperoxidase cell expression qualitative test drug
VN: Thuốc thử xét nghiệm định tính tế bào biểu hiện Myeloperoxidase
Risk Class TBYT Loại B

Registration Details

240002446/PCBB-HCM

000.00.19.H29-241021-0010

FLEX Polyclonal Rabbit Anti-Human Myeloperoxidase Ready-to-Use (Link)

IR511

Company Information

Agilent Technologies Singapore (International) Pte Ltd.

Technical Details

For in vitro diagnostic use. FLEX Polyclonal Rabbit Anti-Human Myeloperoxidase, Ready-to-Use, (Link), is used in immunohistochemistry on the Autostainer Link. This antibody stains cells positive for myeloperoxidase in normal and neoplastic tissue and is a useful tool to distinguish between lymphoma and leukemia. Positive staining supports the diagnosis of neoplastic tissue (i.e., the blasts and the immature cells of acute myelogenous leukemia, preleukemic blast crisis, chronic myelomonocytic leukemia, myelodysplastic syndrome, erythroleukemia, and acute leukemia of other types) (1). Any clinical interpretation of any positive or negative staining result should be supplemented by morphological studies using appropriate controls and should be evaluated in the context of the patient's clinical history and other diagnostic tests by a qualified hematopathologist.

Dates and Status

Oct 24, 2024