ISO 13485 Accredited · SAHPRA Licensed

Biotechnology thatmoves diagnostics forward.

Medical Diagnostech develops and manufactures lateral flow rapid diagnostic test kits using our trade-secret methodology for increased sensitivity and early detection.

Est. 2010
Cape Town
ISO 13485
Accredited
SAHPRA
Licensed
HIV 1/2
HIV 1/2
Rapid lateral flow
Malaria
Malaria
Pf/Pv antigen
COVID-19
COVID-19
Antigen & antibody
Syphilis
Syphilis
Treponemal screen
Accreditations & product categories
ISO 13485 AccreditedSAHPRA LicensedHIVMalariaCOVID-19Pregnancy & OvulationDrugs of AbuseAlcohol
What we do

A focused developer and manufacturer of rapid diagnostics.

From feasibility through validation and manufacture, our team works alongside customers at every stage of the lateral flow lifecycle.

Research & Development

Trade-secret formulations engineered for sensitivity, specificity and stability.

Lateral Flow Manufacturing

ISO 13485 accredited production of rapid diagnostic test kits.

Regulatory Standing

SAHPRA licensed medical device manufacturer in South Africa.

Local & International Supply

Growing local and international client base served from Cape Town.

Featured technologies

Diagnostic platforms engineered for accuracy and access.

IVD

Infectious Disease

HIV, Malaria and COVID-19 — rapid lateral flow test kits.

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Infectious Disease
POC

COVID-19 Self-Test

Antigen self-test cassette for at-home and point-of-care use.

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COVID-19 Self-Test
TOX

Drugs of Abuse & Alcohol

Multi-panel drug self-tests and saliva alcohol screening.

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Drugs of Abuse & Alcohol
WOMEN'S HEALTH

Pregnancy & Ovulation

Pregnancy strip tests and ovulation midstream formats.

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Pregnancy & Ovulation
Manufacturing

Lateral flow production, made in Cape Town.

Our facility manufactures lateral flow rapid diagnostic test kits under an ISO 13485 accredited quality management system and a SAHPRA medical device manufacturing licence.

ISO 13485:2016
Quality Management
SAHPRA Licensed
Medical device manufacturer
24-month shelf life
Robust to extreme storage
Trade-secret methodology
Sensitivity & specificity
Tour our facility
Manufactured diagnostic device
Cape Town manufacturing
ISO 13485 Accredited · SAHPRA Licensed
Product development

From feasibility to validation.

Our experienced R&D scientists work alongside customers through each stage of development, with regular updates, advice and joint troubleshooting.

PHASE 01

Feasibility

Study design based on set specifications; prototypes created and evaluated, ending in a report.

PHASE 02

Optimisation

Prototype refined to consistently and reproducibly meet product requirements.

PHASE 03

Validation

Verification studies on the final methodology to demonstrate supporting product claims.

Partnerships

Manufacturing & product development.

We offer manufacturing and development services for new and innovative lateral flow components and test kits, alongside other medical-related products such as sanitisers and surgical scrubs. Our local and international client base is growing.

Est. 2010
Cape Town based
ISO 13485
Accredited QMS
SAHPRA
Licensed manufacturer
24 months
Optimised shelf life
Quality & compliance

Independently accredited and licensed.

ISO 13485:2016 Accredited
SAHPRA Licensed

Ready to bring better diagnostics to your market?

Talk to our team about product supply, contract manufacturing, distributor partnerships or product development.