Vietnam MOH registration 240000340/PCBB-HCM

IVD Environmental Cultivation Cluster: Blood Culture Bottle for the Detection of Aerobic and Anaerobic Microorganisms

VN: Cụm IVD Môi trường nuôi cấy: Chai cấy máu phát hiện vi sinh vật hiếu khí, kỵ khí

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Bd·Registered Feb 15, 2024

Registration details

Analysis ID: 240000340/PCBB-HCM
Submission ID: 000.00.19.H29-240115-0023
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Bd
Manufacturer Country: Theo theo phụ lục
Product Owner: Bd
Authorized Representative: VĂN PHÒNG ĐẠI DIỆN BECTON DICKINSON ASIA LIMITED TẠI THÀNH PHỐ HỒ CHÍ MINH

Technical details

Intended Use: Product Code: 442054 BD Blood Culture Vial Platelet Aerobic/F is used in conjunction with the BD BACTEC™ FX Blood Culture System to assess the quality of the Leukoreduced Platelet Pool (LRPA) and the Leukoreduced Whole Blood Platelet Pool (LRWBPC) up to 6 units. The BD Blood Culture Vial Platelet Aerobic/F supports the growth of aerobic microorganisms (bacteria and fungi). The BD BACTEC™ FX Blood Culture System ensures extended incubation times up to day 7 for the following cases: • Delayed Leukoreduced Platelet Specimen (LVDS) greater than 48 hours after collection HOẶC • Secondary Culture not performed earlier than day 4 after collection of the leukoreduced platelets. The BD BACTEC™ FX Blood Culture System is used to extend the incubation time up to 5 days for the following cases: • Delayed Leukoreduced Platelet Specimen (LVDS) greater than 36 hours after collection; HOẶC • Secondary Culture not performed earlier than day 3 after collection of the leukoreduced platelets. Additional Information: The BD Blood Culture Vial is used in this qualitative process to detect the presence of live microorganisms in the leukoreduced platelet specimens and is automated on the BD BACTEC™ FX Blood Culture System. Product Code: 442054 BD Blood Culture Vial Platelet Anaerobic/F is used in conjunction with the BD BACTEC™ FX Blood Culture System to assess the quality of the Leukoreduced Platelet Pool (LRPA) and the Leukoreduced Whole Blood Platelet Pool (LRWBPC) up to 6 units. The BD Blood Culture Vial Platelet Anaerobic/F supports the growth of anaerobic microorganisms. The BD BACTEC™ FX Blood Culture System ensures extended incubation times up to day 7 for the following cases: • Delayed Leukoreduced Platelet Specimen (LVDS) greater than 48 hours after collection HOẶC • Secondary Culture not performed earlier than day 4 after collection of the leukoreduced platelets. The BD BACTEC™ FX Blood Culture System is used to extend the incubation time up to 5 days for the following cases: • Delayed Leukoreduced Platelet Specimen (LVDS) greater than 36 hours after collection; HOẶC • Secondary Culture not performed earlier than day 3 after collection of the leukoreduced platelets. Additional Information: The BD Blood Culture Vial is used in this qualitative process to detect the presence of live microorganisms in the leukoreduced platelet specimens and is automated on the BD BACTEC™ FX Blood Culture System.

Dates and status

Registration Date: Feb 15, 2024

About this record

Access comprehensive regulatory information for IVD Environmental Cultivation Cluster: Blood Culture Bottle for the Detection of Aerobic and Anaerobic Microorganisms in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240000340/PCBB-HCM and manufactured by Bd. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN BECTON DICKINSON ASIA LIMITED TẠI THÀNH PHỐ HỒ CHÍ MINH.

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