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Certificate number:
MD 722804
Scope: Design, development and manufacture of DNA FISH probes, ancillary products and in vitro diagnostic kits and reagents for the detection of chromosomal abnormalities in life science research and diagnostic use.
Standard/Scheme number or name | Start Date | Expiry Date |
---|---|---|
ISO 13485: 2016 | 2021-02-16 | 2025-09-15 |
Certificate number:
FM 723073
Scope: Design, development and manufacture of DNA FISH probes, ancillary products and in vitro diagnostic kits and reagents for the detection of chromosomal abnormalities in life science research and diagnostic use.
Standard/Scheme number or name | Start Date | Expiry Date |
---|---|---|
ISO 9001:2015 | 1999-10-15 | 2025-09-15 |
Certificate number:
MDSAP 736531
Scope:
Design, development and manufacture of in vitro diagnostic kits and reagents for the detection of chromosomal abnormalities.
Standard/Scheme number or name | Start Date | Expiry Date |
---|---|---|
MDSAP | 2019-09-18 | 2025-09-15 |
Certificate number:
IVDR 747622
Scope: View Scope(PDF)
Standard/Scheme number or name | Start Date | Expiry Date |
---|---|---|
(EU) 2017/746 Annex IX Chapter I and III | 2023-03-09 | 2028-03-08 |