The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for COVID-19. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals.
This test has been authorized by the FDA under a EUA for professional use CLIA and CLIA WAIVED for Point Of Care.
This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
This product is intended for professional use and not for home use.
FACT SHEET FOR HEALTHCARE PROVIDERS
This test has been authorized by the FDA under a EUA for use by authorized CLIA laboratories. This device is CLIA waived for point of care use for fingerstick whole blood specimens only. The user should be trained in the procedure. Wear appropriate protective attire for your safety when handling patient samples.
This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
There should be a blue line in the control region (next to ) before testing, discard the device if there is no blue line.
100% MADE IN CANADA with 100% Canadian made raw materials. The MSL1PM is a 3 layer procedural mask with ear loops intended for use in clinical applications. Mediguard Systems of Canada is a Health Canada registered medical device establishment, we are ISO 13485 compliant, we are authorized for the production and distribution of all Class 1 medical devices, and serve a global client base
FLUID RESISTANCE, mmHg 80
BFE â?¥ 95%
PFE, @ 0.1 micron â?¥ 95%
DELTA P, mm H2O/cm2 < 4.0
FLAME SPREAD CLASS 1
Take advantage of the high level of compliance offered by ASTM standards and the low exchange rate of our Canadian Dollar.
100% MADE IN CANADA with 100% Canadian made raw materials. The MSL2PM is a 3 layer procedural mask with ear loops intended for use in clinical applications. Mediguard Systems of Canada is a Health Canada registered medical device establishment, we are ISO 13485 compliant, we are authorized for the production and distribution of all Class 1 medical devices, and serve a global client base
FLUID RESISTANCE, mmHg - 120
BFE - 98%
PFE, @ 0.1 micron - 98%
DELTA P, mm H2O/cm2 - < 5.0
FLAME SPREAD - CLASS 1
Take advantage of the high level of compliance offered by ASTM standards and the low exchange rate of our Canadian Dollar.
Nanofiber filtration layer that does NOT rely on static electricity for functionality of filtration efficiency
12 YEAR SHELF LIFE
FDA 510k cleared mask
CE FFP2 NR certified mask (Certification No: 2163-PPE-1433)
High breathability using nanofiber technology
Strong moisture control with 0.1 m filtration efficiency
Lightweight design with each mask weighing less than 4.38g
3-layer ergonomic design covering nose to chin
Functional nose support with a wired flexible fit
Firm mask structure prevents falling off and fogging of glasses
Flexible nylon straps that maintain elasticity after long use
Made in South Korea using patented manufacturing processes with ISO certified facilities
BFE / PFE 97%
Test Agent NaCl and paraffin oil
Flow Rate 95 L/min
T.I.L 2.5% leakage
Inhalation Resistance 33 Pa (at 30 L/min)
Max Pressure 112 Pa (at 95 L/min)
Meets NIOSH inhalation and exhalation resistance testing procedures: CFR 84.172 . Meets FDA/NIOSH MOU 225-18-006 approved for Surgical setting use
99% BFE (Bacterial Filtration Efficiency) according to ASTM F2101.
99.7% Filter Efficiency according to ICS Laboratories Inc.
Berry Amendment (10 U.S.C. 2533a) compliant.
Pre-formed for secure fit.
Moldable nose clip will help provide custom fit and secure seal.
Available in Small and Regular
Latex free: Yes
Model: Molded Cup
Outer Layer: Spun bound cloth/non-woven fabric Filter: Melt-blown non-woven fabric (2 layers) Inner Layer: Needle punch cotton
Nose Clip: 1mm Thick Metal
Nose Foam: Spandex filament sponge bar Headband: Nylon string
Breathing valve: N/A
Health Canada Authorised Rapid Test
The COVID-19 antigen rapid test device is a lateral flow in-vitro immunoassay intended to be used for the qualitative detection of the SARS-CoV-2 viral nucleoprotein. This device will detect both viable and nonviable virus in both nasopharyngeal and oropharyngeal secretions.
This test had been authorized for point of care use by Health Canada and is available for immediate dispatch
MediGuard Systems of Canada is an Authorised distributor of the Assuretech Rapid Antigen test.
Support documentation and details available on request
100% MADE IN CANADA with 100% Canadian made raw materials. The MSK95PR is a 5 layer particulate respirator with ear loops intended for use in civil applications. Mediguard Systems of Canada is a Health Canada registered medical device establishment, we are ISO 13485 compliant, we are authorized for the production and distribution of all Class 1 medical devices, and serve a global client base
PFE, @ 0.1 micron 95%
DELTA P, mm H2O/cm2 < 4.0
FLAME SPREAD CLASS 1
Take advantage of the high level of compliance offered by Canadian Production and the low exchange rate of our Canadian Dollar.
