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Singapore HSA registration DE0509390

Exact HBV Controls

Singapore flagSingapore·CLASS B IVD·Exact Diagnostics·Registered June 13, 2024
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Microbiology
Registration information
Registration Number
DE0509390
Registration Date
June 13, 2024
Retention Due Date
June 12, 2025
Product description
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
Name
Exact Diagnostics
Short Name
Exact Diagnostics
Address
100 South Jones Street, Suite 100, Fort Worth, Texas 76104, UNITED STATES
Registrant
Name
BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Importer
Name
BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Model information
Model Name(s)
HBV-1 High Run Control HBV-1 Low Run Control
Model Identifier(s)
HBVH102 HBVL101
About this record

Access comprehensive regulatory information for Exact HBV Controls in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0509390 and owned by Exact Diagnostics. The device was registered on June 13, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD