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Certificate number:
MD 686778
Scope: The design, development, manufacture and distribution of in-vitro diagnostic analysers, manufacture of in-vitro diagnostic reagents, used in diagnosis and management of cancer, diagnosis of immune status, disease status and autoimmune status, and the identification of drugs of abuse, cardiac markers, protein metabolism, endocrine disorders, blood analytes, blood components, blood gases, coagulation, transmissible agents, sexually transmissible agents, fertility and for immunological typing and therapeutic drug monitoring.
| Standard/Scheme number or name | Start Date | Expiry Date |
|---|---|---|
| ISO 13485: 2016 | 2018-03-19 | 2028-11-05 |
Certificate number:
MDSAP 699499
Scope: The design, development, manufacture and distribution of in-vitro diagnostic analysers, manufacture of in-vitro diagnostic reagents, used in diagnosis and management of cancer, diagnosis of immune status, disease status and autoimmune status, and the identification of drugs of abuse, cardiac markers, protein metabolism, endocrine disorders, blood analytes, blood components, blood gases, coagulation, transmissible agents, sexually transmissible agents, fertility and for immunological typing and therapeutic drug monitoring.
| Standard/Scheme number or name | Start Date | Expiry Date |
|---|---|---|
| MDSAP | 2019-11-06 | 2028-11-05 |