National Association of Testing Authorities, Australia
Scope of Accreditation
Crux Biolabs Pty Ltd
Site
Crux Biolabs Pty Ltd
Accreditation No.
20525
Site No.
24589
Date of Accreditation
05 Apr 2019
Contact
Dr Thomas Mikeska
P: +61 (03) 97630110
Availability
Services conditionally available to external clients
Supervision
Not Applicable
Scope of Accreditation
Crux Biolabs Pty Ltd
ISO/IEC 17025 (2017)
Healthcare, Pharmaceutical and Media Products
| Service | Product | Determinant | Technique |
|---|---|---|---|
| Analysis in support of clinical trials and/or pre-clinical studies | Animal biological samples; Human biological samples | Anti-drug antibodies measurement; Impact of pharmaceuticals, biological agents and vaccines on disease and treatment outcomes | Electrochemiluminescence (ECL) |
| Pharmacokinetic (PK) parameters | Electrochemiluminescence (ECL); Enzyme linked immunosorbent assay (ELISA) | ||
| Cell characterisation, identification and isolation | Nucleic acid extraction | ||
| Identification and analysis of cytokines | ELISpot assays | ||
| Identification and analysis of cytokines; Identification and analysis of proteins | Enzyme linked immunosorbent assay (ELISA); Multiplex bead array assays | ||
| Cell characterisation, identification and isolation | Flow cytometry; Isolation and cryopreservation of mononuclear cells, plasma and serum | ||
| Human biological samples | Identification and analysis of cytokines | Electrochemiluminescence (ECL) |
The only data displayed is that deemed relevant and necessary for the clear description of the activities and services covered by the scope of accreditation.
Grey text appearing in a SoA is additional freetext providing further refinement or information on the data in the preceding line entry.
Accreditation No.
20525
Site No.
24589
Print date
04 Dec 2023
END OF SCOPE
