HSA · registration DE0505100Thermo Scientific MAS® Omni•CORE™
SingaporeClinical chemistryClass CMicrogenics Corporation
Official record identity
- Registration number
- DE0505100
- Model name
- MAS® Omni•CORE™ Level 1; MAS® Omni•CORE™ Level 2; MAS® Omni•CORE™ Level 3
- Model identifier
- OCR-101; OCR-202; OCR-303
- Registration date
- November 03, 2020
Classification
- Risk class
- Class C
Official value: CLASS C
Published parties
- Product owner
- Microgenics Corporation
- Registrant / registration holder
- THERMO SCIENTIFIC MICROBIOLOGY PTE. LTD.
Official description
Thermo Scientific MAS® Omni•CORE™ is intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Include Omni•CORE with patient serum specimens when assaying for any of the constituents.
Additional source fields
- Product owner address
- 46500 Kato Road, Fremont, CA 94538, United States
- Registrant address
- 33 MARSILING IND ESTATE ROAD 3, #07-06, Singapore 739256
About this record
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.