HSA · registration DE0509391Exact Diagnostics HIV-1 Controls
- Registration number
- DE0509391
- Model name
- HIV-1 High Run Control; HIV-1 Low Run Control; HIV-1 RNA Screen Control
- Model identifier
- HIVH102; HIVL101; HIVSCREEN
- Registration date
- June 13, 2024
- Risk class
- Class B
- Product owner
- Exact Diagnostics
- Registrant / registration holder
- BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
The EDX HIV-1 Controls are external quality controls, intended to be used with HIV-1 assays to monitor the performance of that given assay. EDX HIV-1 Controls are calibrated against the 3rd WHO International Standard for HIV (10/152). The EDX HIV-1 Low and High Run Controls are used to monitor the presence of Human Immunodeficiency Virus (HIV-1) RNA. Routine use of EDX HIV-1 Low and High Run Controls allows laboratories to evaluate the day-to-day and lot-to-lot variation of their molecular assay and test for operator proficiency. EDX HIV-1 RNA Screen Control is intended to test the entire process of a variety of blood donor screening assays through extraction, amplification, and detection.
- Product owner address
- 100 South Jones Street, Suite 100, Fort Worth, Texas 76104, United States
- Registrant address
- 3A INTERNATIONAL BUSINESS PARK, #11-10/16, ICON@IBP, Singapore 609935
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.