Medical Diagnostech Pty Ltd

Trading as

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

Human health activities

Country / HQ

South Africa

Quality management systems

Markets currently sold to:

Activities

We are interested in expanding our operation through:

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