Quality

Standard: CE 1 Number: ECREP 20220119.26 Issue Date: 2022-01-19 Expiry Date: 2025-03-28 Scope/Range: IVD-Directive 98/79 Issued By: CMC Medical Devices&Drugs S.L.

Standard: CE approved product listing 1 Number: ECREP 20220119.26 Issue Date: 2022-01-19 Expiry Date: 2025-03-28 Scope/Range: IVD-Directive 98/79 Issued By: CMC Medical Devices&Drugs S.L.

Standard: CE 2 Number: ECREP 20220520.13 Issue Date: 2022-05-20 Expiry Date: 2027-03-28 Scope/Range: IVD-Directive 98/79 Issued By: CMC Medical Devices&Drugs S.L.

Standard: CE approved product listing 2 Number: ECREP 20220520.13 Issue Date: 2022-05-20 Expiry Date: 2027-03-28 Scope/Range: IVD-Directive 98/79 Issued By: CMC Medical Devices&Drugs S.L.

Standard: CE approved product listing 3 Number: ECREP 20220520.13 Issue Date: 2022-05-20 Expiry Date: 2027-03-28 Scope/Range: IVD-Directive 98/79 Issued By: CMC Medical Devices&Drugs S.L.

Standard: US FDA Registration Number: N/A Issue Date: 2024-01-03 Expiry Date: 2024-12-31 Scope/Range: US and other countries except Europe Issued By: US FDA

Standard: Quality Management System ISO 13485 Number: 131032 Issue Date: 2025-03-17 Expiry Date: 2028-04-07 Scope/Range: molecular testing lines Issued By: NQA

Standard: NMPA Number: 20223221751 Issue Date: 2022-12-20 Expiry Date: 2027-12-20 Scope/Range: molecular testing lines Issued By: Chinese Food and Drug Administration