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Test Kit Registration

A test kit is an apparatus that contains a controlled substance, a reagent or a buffering agent, and contents not intended or likely to be consumed or administered to a human or an animal. It is designed for use during the course of a chemical or analytical procedure for a medical, laboratory, industrial, educational or research purposes.

Companies wishing to manufacture and sell these test kits must apply to obtain a Test Kit Number. Below you will find the appropriate form and a guidance document to help prepare your application.

• Test Kit Registration Application Form
• Test Kit Registration Guidance Document