Vietnam MOH registration 240002984/PCBB-HN
IVD Chemical Dye Cluster for In Vitro Diagnostic Testing
VN: Cụm IVD Hóa chất nhuộm dùng cho xét nghiệm trong chẩn đoán in vitro
Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Bio-Gram Diagnostics GmbH·Registered Oct 31, 2024Registration details
- Analysis ID
- 240002984/PCBB-HN
- Submission ID
- 000.00.19.H26-241026-0007
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
Company information
- Manufacturer
- Bio-Gram Diagnostics GmbH
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Bio-Gram Diagnostics GmbH
- Authorized Representative
- CÔNG TY TNHH GIẢI PHÁP THIẾT BỊ Y TẾ VIỆT NAM
Technical details
- Intended Use
- 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
- Registration Date
- Oct 31, 2024
About this record
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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