Singapore HSA registration DE0509265
Thermo Scientific MAS® Bilirubin
Singapore·CLASS B IVD·Microgenics Corporation·Registered May 08, 2024Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0509265
- Registration Date
- May 08, 2024
- Retention Due Date
- May 07, 2026
Product description
MAS® Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include Bilirubin with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Product Owner
- Short Name
- Microgenics Corporation
- Address
- 46500 Kato Road,, Fremont, CA 94538, UNITED STATES
Registrant
- Address
- 33 MARSILING IND ESTATE ROAD 3, #07-06, SINGAPORE 739256
Importer
- Address
- 33 MARSILING IND ESTATE ROAD 3, #07-06, SINGAPORE 739256
Model information
- Model Name(s)
- MAS® Bilirubin Liquid Assayed Bilirubin Control Level 1 MAS® Bilirubin Liquid Assayed Bilirubin Control Level 2 MAS® Bilirubin Liquid Assayed Bilirubin Control Level 3
- Model Identifier(s)
- BC101 BC102 BC103
About this record
Access comprehensive regulatory information for Thermo Scientific MAS® Bilirubin 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 DE0509265 and owned by Microgenics Corporation. The device was registered on May 08, 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