Medical Diagnostech Pty Ltd

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Trading as
Medical Diagnostech Pty Ltd
Overview of your organisation

Medical Diagnostech was established in 2010 as a developer and manufacturer of rapid diagnostic test kits.

We manufacture high quality rapid diagnostic assays and test kits using our trade secret methodology for increased accuracy via optimal sensitivity for early detection without compromising specificity.

Our products are robust and are optimized to withstand extreme storage conditions for up to 24 months. Assays are manufactured under ISO 13485 accreditation, SAHPRA Medical Device Manufacturer’s License, and includes NICD, WHO, CE, and FDA approved products.

Products include fuel marker identification and adulterant assays, substance abuse assays as well as infectious disease assays including COVID-19, HIV 1/2 and Malaria. We also offer contract manufacturing and development services.

Our team of experienced scientists work alongside customers through each stage of development.

Quality management systems

ISO-9001
No
ISO-13485
Yes

Markets currently sold to:

South Africa
Private sector
Are you exporting any of your products?
No
Are you looking for partners to help you export or assistance with FDA and CE registration?
Yes
Does your company perform research and development?
Yes
Would you be interested in manufacturing innovations developed by research institutions in South Africa?
Yes
Would you be interested in performing research and development with external parties?
Yes
Would you be interested in collaborating with research institutions in South Africa to develop your own innovations?
Yes
What type of working relationship would you be interested in having with research institutions?
Supervised postgraduate students
Co-development
SAHPRA registered
Yes
Main product classes
Class A
Class B
Class C
Class D
Which of the following materials are used in your manufacturing facility?
Plastics
Main product areas
Consumables

Activities

Product design
Inhouse
Product manufacture
Inhouse
Packaging
Inhouse
Sterilization
Inhouse
Re-packaging/configuring of imported goods and labelling
Inhouse

We are interested in expanding our operation through:

Financial assistance/investment
Physical address

Unit 3 on London Circle
Brackengate Business Park
Brackenfell
Western Cape
7561

Street name and number
3 London circle
Website link
http://medi-tech.co.za/
Industry
Human health and social work activities
Medical Devices
Country / HQ
South Africa

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