10/19/2021 Medical devices for expanded COVID-19 use: Authorized medical devices - Canada.

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

medical devices for expanded use
Overview List of authorized testing devices List of authorized medical devices other
than testing

List of medical devices for expanded List of medical devices for exceptional List of products no longer authorized
use import and sale under IO

Medical devices on this list have an expanded indication for use or intended use related to COVID-19. Diagnostic,
treatment, mitigation or prevention claims are based on known evidence as outlined in section 13 of Interim Order No. 1
for importing and selling medical devices (March 18, 2020, to March 1, 2021) or section 14 of Interim Order No. 2 for
importing and selling medical devices (enacted March 1, 2021). Any expanded indications that were first authorized under
Interim Order No. 1 are deemed as authorized under Interim Order No. 2.

We are updating this list when new expanded uses are identified.

Medical devices on this list are granted an expanded indication for use or intended use, to include COVID-19 related
diagnostic, treatment, mitigation or prevention claims based on known evidence.

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List of medical devices for expanded use in relation to the COVID-19 pandemic

Date of
Medical device or COVID- authorization
19 medical device   Expanded use   Supplementary Information   (YYYY-MM-DD)  

BD Veritor System for Rapid
Detection of SARS-CoV-2
(318420)
Visual interpretation of results.
BD Veritor System for Rapid Detection
of SARS-CoV-2 device is a
chromatographic digital immunoassay
intended for the direct and qualitative
detection of SARS-CoV-2 nucleocapsid
antigens in nasal swabs from
individuals who are suspected of
COVID-19 by their healthcare provider
within the first five days of the onset of
symptoms. The results are interpreted
using the BD Veritor Plus Analyzer. The
indication for use has been expanded
to include visual interpretation of the
results.
The expanded use, allowing visual
interpretation, does not extend to
asymptomatic serial testing. When
performing asymptomatic serial
testing, the instructions for use should
be followed and the BD Plus Analyzer
should be used to interpret the results.
Shelf life extension
BD Veritor System for Rapid Detection
of SARS-CoV-2 device is a
chromatographic digital immunoassay
intended for the direct and qualitative
detection of SARS-CoV-2 nucleocapsid
antigens in nasal swabs from
individuals who are suspected of
COVID-19 by their healthcare provider
within the first five days of the onset of
symptoms, or from individuals without
symptoms or other epidemiological
reasons to suspect COVID-19 when
tested twice over two or three days
with at least 24 hours, and no more
than 48 hours, between tests. The
results are interpreted using the BD
Veritor Plus Analyzer. The shelf life of
this device has been authorized to be
16 months, an extension of 4 months
from the previously authorized 12
months.
Visual interpretation of results. 2021-10-08 (Visual
Interpretation of
The instruction for use should be
results)
followed for the sample collection,
preparation and loading. Once the 2021-10-18 (Shelf life)
sample has been loaded wait the
prescribed time of 15 minutes before
interrupting the results.
When the test is ready, elevate the
device, if necessary, to a position where
the device reading window is optimally
positioned for user visualization. Slowly
tilt the device back and forth to remove
unnecessary glare. Examine the device
reading window for the visual presence
of lines in the Control (C), Test (T) and
Non-specific (N) regions.
Visual interpretation of the results:
Negative Result: Control line only
Positive Result: Control line and
Test line
Invalid Result will be any of the
following
Test line only
Control line and Non-specific
line
Test line and Non-specific line
Non-specific line only
No line
All 3 lines, Control, Test and
Non-specific lines
The limit of detection when interpreting
the results visually increases to 7.8 x 103
TCDI50/ml. This increase in the limit of
detection carries a risk. However, should
there be doubt in the visual read
interpretation, the device can be
inserted into the analyzer and the
standard steps outlined in their
instructions for use should be followed.
The risks associated with increased limit
of detection should be mitigated by
utilizing the analyzer in cases of doubt.
The anticipated benefit of this expanded
use is the increase flexibility in workflow
while using the BD Veritor System for
Rapid Detection of SARS-CoV-2 (IO

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10/19/2021 Medical devices for expanded COVID-19 use: Authorized medical devices - Canada.ca

Medical device or COVID-
19 medical device  
Date of
authorization
Expanded use   Supplementary Information   (YYYY-MM-DD)  
318420). The safety and effectiveness of
this device is maintained while utilizing
this expanded use.

Shelf life extension

The instructions for use as well as the

marked expiry date on the product
provided with the BD Veritor System for
Rapid Detection of SARS-CoV-2 testing
device (IO 318420) from the
manufacturer includes a stated
expiry/shelf-life of 12 months. This
expiry date is based on an amendment
authorization for IO 318420 extending
the shelf life from 6 months to 12
months. Health Canada has extended
the expiry date by an additional 4
months to a total of 16 months. Becton
Dickson and Company, the
manufacturer, will not be incorporating
the 16 month shelf-life on their
packaging, labelling, or instructions for
use. Therefore, the stated shelf
life/expiry date has 4 additional months
before the device expires.

The anticipated benefit of this expanded

use is the continued safe and effective
use of testing devices beyond the stated
expiry date. Through this shelf life
extension the purchased tests can safely
be used in the detection of SARS-CoV-2.

In order to aid in the determination of

the correct expiry date for your device
Becton Dickson and Company has
provided additional instructions based
on the current expiry date of the device.
Follow the below guide to determine the
expiry date of your device.

If the expiry date printed on the label

ends in 2021,

Then, the new expiry date = Expiry date

printed on the label + 10 months

For example, products with a printed

expiry date of 2021-06-09, now have a
new expiry date of 2022-04-09

If the expiry date printed on the label

ends in 2022,

Then, the new expiry date = Expiry date

printed on the label + 4 months

For example, products with a printed

expiry date of 2022-01-09, now have a
new expiry date of 2022-05-09

Date modified:
2021-10-18

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