IVD systems, ready-to-use assays and biochemicals for haemostasis research and diagnostics
5-Diagnostics AG
Basel (CH) · Eastbourne (GB)New on Amplifa
About 5-Diagnostics
5-Diagnostics AG, headquartered in Basel, is a provider of innovative IVD systems, ready-to-use assays and biochemicals for the haemostasis research and diagnostics market. The portfolio includes antibodies, auxiliary reagents, calibrators and controls, chromogenic and fluorogenic substrates, deficient and inhibitor plasmas, proteins and enzymes as well as reagents for quality control according to the European and US pharmacopoeias (EP/USP) and finished test kits. The company carries out sourcing and manufacturing of haemostasis products and distributes them via a centrally managed global network of sales representatives and product specialists as well as through an online webshop with a product information system. Its customers are clinical, academic and industrial groups from in-vitro diagnostics, haemostasis research and pharmaceutical quality control. The quality management system is certified to ISO 9001:2015; in addition to its headquarters in Basel, the company maintains a branch in Eastbourne, United Kingdom.
- Site
- Basel
- Processes
- Sales and marketing of diagnostics, Online webshop and product information system, Sourcing and manufacturing of haemostasis products
- Materials
- IVD systems and test kits, EP/USP quality control reagents, Chromogenic and fluorogenic substrates, Plasmas, calibrators and controls, Proteins and enzymes, Auxiliary reagents and buffers
- Certificates
- ISO 9001:2015
- Industries
- In-vitro diagnostics (IVD), Haemostasis research, Clinical diagnostics, Pharmaceutical quality control (EP/USP)
- 01
Sourcing and manufacturing of haemostasis products
- 02
Quality control according to EP/USP
- 03
Sales and marketing via a global network
- 04
Online webshop and product information system
- 05
Customer support and technical consulting
Product Groups and Reagents
IVD systems and test kits
Finished test kits for haemostasis diagnostics, including ELISA kits and starter sets for EP/USP assay procedures.
EP/USP quality control reagents
Starter sets for Anti-Xa and Anti-IIa assays for the quality control of heparins according to EP and USP.
Chromogenic and fluorogenic substrates
Substrates such as thrombin and Factor Xa substrates for chromogenic assay formats.
Plasmas, calibrators and controls
Normal, deficient and inhibitor plasmas as well as positive controls for coagulation tests.
Proteins and enzymes
Human and bovine enzymes such as thrombin and Factor Xa as well as proteins such as antithrombin.
Auxiliary reagents and buffers
Buffer salts according to USP/Ph.Eur. for the quality control of pharmaceutical preparations.
Locations
Basel
CHHeadquarters
Eastbourne
GBBranch office (5 Diagnostics Ltd, Unit 11, The Old Printworks, 20 Wharf Road)
Products
Inside the production
Industries
Additional services
Quality
5-Diagnostics is certified to ISO 9001:2015 (certificate 00156-QMS-001, 3core2 Certification) and works with a network of renowned, ISO/FDA-accredited suppliers and IVD manufacturers.
| Evidence | Basel |
|---|---|
| ISO 9001:2015 |
History
- 2016
Initial registration of the ISO 9001 certificate (28.10.2016)
- 2022
Certificate transfer to 3core2 Certification (22.08.2022)
- 2025
Recertification to ISO 9001:2015 (18.09.2025)