HSA · registration DE0509390Exact HBV Controls
- Registration number
- DE0509390
- Model name
- HBV-1 High Run Control; HBV-1 Low Run Control
- Model identifier
- HBVH102; HBVL101
- Registration date
- June 13, 2024
- Risk class
- Class B
- Product owner
- Exact Diagnostics
- Registrant / registration holder
- BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Exact HBV High and Low Run Controls are external quality controls, intended to be used with HBV assays to monitor the performance of that given assay. Exact HBV High and Low Run Controls are calibrated against the 3rd WHO International Standard for Hepatitis B (10/264). The controls are used to monitor the presence of Hepatitis B Virus (HBV) DNA. Routine use of Exact HBV Low and High Run Controls allow laboratories to evaluate the day-to-day and lot-to-lot variation of their molecular assay and test for operator proficiency.
- 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.