S0004217
OnSite COVID-19 Ag Self-Test, 1T/KIT
OnSite COVID-19 Ag Self-Test 1T/KIT.
Indicative Price 1.95 USD
General description:
OnSite COVID-19 Antigen Self-Test 1T/KIT
Intended use:
The OnSite COVID-19 Ag Self -Test is a single-use lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab specimens from individuals suspected of COVID-19, within the first seven days of the onset of symptoms. This product is intended to be used for self-use and/or for adults over the age of 18 in a non-laboratory setting, or by children ages 12 and up with adult supervision. For in-vitro diagnostic use only.”
Technical specifications:
·Assay Technology: Lateral flow chromatographic immunoassay.
·Kit size: 1 Test/KIT.
·Specimen type: Nasal Swab specimen.
·Time to result: 15 minutes.
·Clinical sensitivity: 91.2%
·Clinical specificity: 99.6%.
·Does not differentiate between SARS-CoV and SARS-CoV-2
Manufacturer product reference: CTK Biotech, Inc, R0182CST-1T.
Kit Components:
1x Buffer and nozzle pouch.
1x Cassette pouch.
1x Swab.
1x Waste bag.
1x IFU.
Items required, but not supplied:
A mirror, tissues, a way to time for test results, and soap and water or hand sanitizer.
Shelf life:
12 months from manufacturing date.
Storage & transportation condition:
The kit should be stored in a dry place at 2 ̊C to 30 ̊C away from direct sunlight.
Packaging & labelling:
Primary packaging: All contents of OnSite COVID-19 Ag Self-Test 1Test/KIT.
Secondary packaging: One Kit OnSite COVID-19 Ag Self-Test 1Test/KIT.
Weight & volume:
Estimated weight: 0.037kg
Estimated volume: 135mmx80mmx22.5mm.
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