Vietnam MOH registration 2402922ĐKLH/BYT-HTTB
Khay thử xét nghiệm bán định lượng độ đàn hồi huyết khối trong quá trình đông máu
VN: Khay thử xét nghiệm bán định lượng độ đàn hồi huyết khối trong quá trình đông máu
Vietnam·Risk Class TTBYT Loại C·ROTEM® sigma complete·Accriva Diagnostics, Inc.·Registered Oct 22, 2024Registration details
- Analysis ID
- 2402922ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-231222-0004
- Product Type
- ROTEM® sigma complete
- Product Code
- 555501
Company information
- Manufacturer
- Accriva Diagnostics, Inc.
- Manufacturer Country
- UNITED STATES
- Product Owner
- Tem Innovations GmbH
- Authorized Representative
- CÔNG TY CỔ PHẦN MEDCOMTECH
Technical details
- Intended Use
- For in vitro diagnostic use only. The ROTEM® sigma complete is a test slide of the ROTEM® system containing reagents to assess coagulation and its interaction with platelets in the whole blood that has been citrate-anticoagulated.
Dates and status
- Registration Date
- Oct 22, 2024
About this record
Access comprehensive regulatory information for Khay thử xét nghiệm bán định lượng độ đàn hồi huyết khối trong quá trình đông máu in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2402922ĐKLH/BYT-HTTB and manufactured by Accriva Diagnostics, Inc.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN MEDCOMTECH.
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