RESZON COVID-19 RAPID ANTIGEN TEST
(ORAL & NASAL SWAB SAMPLES) – FOR SELF-TESTING
MDA registration number: IVDC4716022-109725
The Reszon COVID-19 Rapid Antigen Test (Oral & Nasal Swab Samples) is lateral flow assay designed for the qualitative detection of specific SARS-CoV-2 antigen in human oral and anterior nasal swab specimen. It is intended to be used for the detection of SARS-CoV-2 virus infection. The results obtained should not be the sole determinant for clinical decision. The Reszon COVID-19 Rapid Antigen Test (Oral & Nasal Swab Samples) is intended for use for home self-testing.
Platform | Immunochromatographic Assay |
Format | Cassette |
Detection | Specific SARS-CoV-2 antigen |
Specimen | Oral & Nasal Swab Samples |
Sensitivity* | 97.24% |
Specificity* | 100% |
Assay Time | 15-20 minutes |
Shelf Life** | 24 months |
* Vs FDA Emergency Use Authorized real-time RT-PCR
** From date of manufacture
Suitable for:
• Individuals who wish to know their status on COVID-19 infection (symptomatic and
asymptomatic regardless of their vaccination status)
• Individuals who have close contact with COVID-19 positive patients
• Individuals with suspected exposure to coronavirus
• Individuals who show symptoms related to COVID-19 (fever, dry cough, tiredness, sore
throat, headache etc)
• Employees to perform regular testing to avoid workplace transmission
• Other appropriate and necessary screenings (such as International Entrance, cross-state,
pre-employment screening, pre-admission to higher learning institutions etc.)
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Cat. No. |
Product Description |
Test Specimen |
Product Format |
Intended Use |
Storage Temp |
Packing Size |
---|---|---|---|---|---|---|
RCV-RD0201SN-01 |
Reszon COVID-19 Rapid Antigen Test (Oral & Nasal Swab Samples) |
Oral & Nasal Swab Samples |
Cassette |
Coronavirus disease |
4-30℃ |
1 T/ Kit |
RCV-RD0201SN-10 |
Reszon COVID-19 Rapid Antigen Test (Oral & Nasal Swab Samples) |
Oral & Nasal Swab Samples |
Cassette |
Coronavirus disease |
4-30℃ |
10 T/ Kit |