Case Overview

Case Description

This case describes the requirements for the import of diagnostic test kits. Diagnostic test kits included in this case may be imported to diagnose conditions in humans, animals and the environment.

Diagnostic test kits covered by this case include those testing for:

1. pathogens (e.g. viruses, bacterial, prions)
   

2. substances (e.g. drugs, chemicals)
   

3. conditions (e.g. vitamins, minerals, pregnancy, hormone levels)
   

4. environmental conditions.
   

Diagnostic test kits may also be known as in-vitro diagnostics (IVDs). Diagnostic test kits may also be known by the technique they employ, such as, polymerase chain reaction (PCR) kits, or enzyme linked immunoassays (ELISA) kits.