Automated Hematology Analyzer
- Analysis ID
- 230000019/PCBB-BD
- Submission ID
- 000.00.17.H09-230421-0001
- Product Type
- ABX Pentra XL80
- Manufacturer
- Horiba ABX SAS
- Intended Use
- This device is a fully automated hematology analyzer used to diagnose blood samples in the laboratory. The device can perform tests with: - CBC (Complete Blood Count) mode. - DIFF mode (CBC + WBC Differential). Integrated Workstation: The Pentra XL80 device has an integrated workstation that allows: -Automatic result confirmation. -Automatic rejection of results. -Automatic notification of re-run results. -Automatic adjustment of results. -Delta check calculation.
- Registration Date
- May 04, 2023
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Access comprehensive regulatory information for Automated Hematology Analyzer 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 230000019/PCBB-BD and manufactured by Horiba ABX SAS.
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