Authorized medical devices for uses related to COVID-19: List of authorized testing devices

The list of authorized testing devices has been updated to include the available instructions for use for COVID-19 tests. Please refer to this new section for more information before searching for the COVID-19 test you are looking for.

* Point-of-care testing devices (rapid tests) and self-testing devices totals include antigen, nucleic acid (PCR) and serological testing devices.

Health Canada is receiving a very high volume of requests for authorization. We are unable to prioritize requests for status updates at this time. If you learned recently that a device was authorized, please allow at least 48 hours for this list to be updated.

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Authorization of COVID-19 testing devices

Health Canada has authorized a variety of COVID-19 tests based on data supporting their intended use.

Each test is authorized for:

Authorizations under the Interim Order

We have authorized the following testing devices for sale or import in Canada through Interim Order No. 3 for importing and selling medical devices (enacted February 21, 2022). Some devices were first authorized under Interim Order No. 1 for importing and selling medical devices (March 18, 2020, to March 1, 2021) or Interim Order No. 2 for importing and selling medical devices (March 1, 2021, to February 21, 2022). Any testing device that was first authorized under Interim Order No. 1 or Interim Order No. 2 is deemed as authorized under Interim Order No. 3.

The entries in this list represent each individual device identifier included on each interim order (IO) authorization. In other words, a single IO authorization may be for multiple devices, such as a testing device and control kits, that are meant to be used together to conduct the test.

Within the IO authorization, each device is listed separately. The "IO authorization date" column indicates the first date that the testing device was authorized for sale. Manufacturers may amend their IO authorizations to add additional devices over time. The date that new device identifiers are added is reflected in the "device first issued" column.

Using testing devices as directed

Always follow the instructions contained in your test kit or provided by your local health authority. The instructions tell you how to collect a sample and take the test. They are written specifically for that type of kit. If you take a sample in a different way, your test result may be inaccurate.

Health Canada works closely with manufacturers and public health partners to ensure the most up-to-date information is made available.

The Canadian Agency for Drugs and Technologies in Health (CADTH), conducted an environmental scan related to sample collection for testing during the Omicron variant. They looked at scientific literature as well as recommendations in Canadian and international jurisdictions. We reviewed these findings and continue to recommend that COVID-19 testing devices be used according to the instructions contained in the test kit.

Review the full CADTH report titled Self-collection of nose and throat swab samples for SARS-CoV-2 antigen testing

Medical device incidents

If you have witnessed or experienced a problem with a medical device, including a COVID-19 test, you should report it. You should report the problem directly to the manufacturer of the test. Look for contact details for the manufacturer on the box and/or the test's instructions for use.

You may also report your concern directly to Health Canada.

Understanding the "testing information" column

For each device, the following table identifies the authorized technology type, intended setting(s), sample type(s), intended population(s), shelf life and sensitivity.

Technology types

Intended setting

Devices may be authorized for more than 1 type of setting. For example:

Refer to the point-of-care or self-testing webpage for more information.

Sample type

Devices may be authorized for multiple sample types and can include the following:

For specific sample collection methods, look for the instructions for use provided for each specific device.

Intended population

Devices have been authorized for use by different types of patients. The following table indicates all authorized patient types, along with any differences in the sensitivity values associated with the intended population:

Shelf life

The following table indicates the most recently authorized shelf life of a device. Extensions for shelf life may be granted:

For more information on tests that may have an expansion-of-use authorization, please visit List of medical devices for expanded use.

Health Canada continues to work closely with our federal, provincial and territorial partners, as well as the manufacturing community, to support additional shelf life extensions on an ongoing basis.

Sensitivity

Sensitivity values are presented to provide transparency around clinical performance data that were filed with Health Canada at the time of submission. Sensitivity is a measure of the accuracy of a test against a reference standard. Only the most conservative values pertaining to SARS-CoV-2 are presented where either:

Tests that identify antibodies (serological tests) do not have their sensitivity value posted in the table. The sensitivity value for these tests depends on many factors. For more information, please consult the instructions for use provided with your test. For serological tests within the testing information column, the target epitope will be identified instead of sensitivity.

Tests that identify antibodies to the spike protein of the SARS-CoV-2 virus, however, will be unable to distinguish between people who have been infected and who have been vaccinated.

Variants

Health Canada is working proactively with manufacturers of approved COVID-19 test devices to assess the impact of novel variants of public health concern. Manufacturers who identify a concern about the performance of their test as a result of a novel variant are expected to report these concerns to us. We will assess these concerns and take necessary action to mitigate any risks.

Additional attributes

The table also indicates if the following apply to any of the authorized devices:

Visual read versus instrument read

Results of the COVID-19 test can be displayed:

The testing information column indicates if the test can be read on an instrument or visually as follows:

Multiplex

Some COVID-19 testing devices allow for other respiratory viruses (for example, influenza A and B and RSV) to be detected at the same time. These tests are indicated by the term multiplex.

Self-collection

Some COVID-19 testing devices may be used by a person to collect their own nasal or saliva samples under the supervision of a health care provider. These testing devices only apply to point-of-care and lab-based tests, as self-tests do not require supervision by a health care provider.

Sample pooling

Some COVID-19 testing devices make it possible to pool samples together for testing, but this strategy will differ from test to test. For more information, please consult the "instructions for use" on how sample pooling may be used with the relevant testing device.

Expanded use

The Interim Order permits the authorization of new COVID-19 uses for devices already approved in Canada when scientific data supports this. COVID-19 testing devices that have received an expanded use authorization will show the symbol EU. The List of medical devices for expanded use provides additional information on the expansion of use for specific COVID-19 testing devices.

Authorized instructions for use

To help consumers use COVID-19 testing devices safely and effectively, we have published available authorized instructions for use (IFU) for authorized devices.

To access the relevant IFU for that device, please click on the hyperlink in the "device identifier" column in the following table.

Please note that not all device identifiers will have an IFU.

Some devices will have multiple versions of IFUs for a single device to account for different configurations of their test kit. For example, an authorization can have a nasal version and a nasopharyngeal version, each with its own device identifier and IFU.

Unlike self-tests, which require IFUs in both official languages, testing devices that are sold for professional use may include an IFU in only 1 official language. If an IFU is available in only 1 official language, contact the manufacturer to request it in the other official language.

All manufacturers are strongly encouraged to provide the most up-to-date version of their IFUs, in both official languages, for publication on this list and when selling their devices in Canada.

Please note that for recently authorized devices, there may be a delay in posting the IFU in both official languages due to translations and finalization of the labelling.

Authorized testing devices list

This list is updated every day by 5 a.m. EST.

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