HSA · registration DE0504843Thermo Scientific MAS® CSF
- Registration number
- DE0504843
- Model name
- MAS® CSF (Level 1, Level 2)
- Model identifier
- CSF-MP
- Registration date
- August 19, 2020
- Source update date
- March 08, 2025
- Risk class
- Class B
- Product owner
- Microgenics Corporation
- Registrant / registration holder
- THERMO SCIENTIFIC MICROBIOLOGY PTE. LTD.
MAS® CSF is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many cerebrospinal fluid determinations. Include MAS CSF control with patient cerebrospinal fluid 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 address
- 46500 Kato Road,, Fremont, CA 94538, United States
- Registrant address
- 33 MARSILING IND ESTATE ROAD 3, #07-06, Singapore 739256
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.