IVD Chemical Dye Cluster for In Vitro Diagnostic Testing - Vietnam Registration 240002984/PCBB-HN
Access comprehensive regulatory information for IVD Chemical Dye Cluster for In Vitro Diagnostic Testing 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 240002984/PCBB-HN and manufactured by Bio-Gram Diagnostics GmbH. The authorized representative in Vietnam is CÔNG TY TNHH GIẢI PHÁP THIẾT BỊ Y TẾ VIỆT NAM.
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Device Details
Registration Details
240002984/PCBB-HN
000.00.19.H26-241026-0007
Theo theo phụ lục
Theo phụ lục
Technical Details
Used in human cell diagnosis to assess the blood and tissue composition of the sample. The staining solution allows for the evaluation of the structure of the target cells in the sample, such as the whole blood smear. The images obtained after staining help professional users determine the shape and structure of the cell components. Used to observe blood cells such as red blood cells, white blood cells, and platelets under the microscope. It allows for the differentiation of different types of cells and the identification of pathological changes such as parasitic infection or infection. This is particularly useful for diagnosing diseases such as malaria, leishmaniasis, babesiosis, and other types of infections. Used to observe and differentiate between Gram-positive and Gram-negative bacteria. In human cell diagnosis, this product line is used in the staining process to examine the bacterial composition of samples of human origin, such as blood, urine, feces, secretions, cerebrospinal fluid, skin scrapings, wounds, or body cavities, biopsies, and washings or flushings from deeper body regions. The microscopic images of the stained samples support professional users in recognizing the shape and structure of Gram-positive and Gram-negative bacteria, thus facilitating the initial step towards correct diagnosis and appropriate antibiotic treatment.
Dates and Status
Oct 31, 2024

