RESZON COVID-19 Rapid Antigen Test (Nasal Swab) – FOR Self-Testing

RESZON COVID-19 RAPID ANTIGEN TEST
(NASAL SWAB) – FOR SELF-TESTING

MDA Registration Number: IVDC5654022-103435

The Reszon COVID-19 Rapid Antigen Test (Nasal Swab) is lateral flow assay designed for the qualitative detection of specific SARS-CoV-2 antigen in human 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 (Nasal Swab) is intended for use for home self-testing.

 

Platform Immunochromatographic Assay
Format Cassette
Detection Specific SARS-CoV-2 antigen
Specimen Nasal swab
Sensitivity* 97.17%
Specificity* 100%
Assay Time 15-20 minutes
Shelf Life** 18 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.)

Click Here for Mandatory Form

-Mandatory Customer Record Form under mandate of MDA Malaysia
-Borang Rekod Pelanggan di bawah mandate MDA Malaysia

Click Here for MySejahtera Update

-Update self-test result to MySejahtera
-Melaporkan keputusan ujian kendiri ke MySejahtera

Cat. No.

Product Description

Test Specimen

Product Format

Intended Use

Storage Temp

Packing Size

RCV-RD0201N-01

Reszon COVID-19 Rapid Antigen Test (Nasal Swab)

Nasal swab

Cassette

Coronavirus disease
COVID-19

4-30℃

1 T/ Kit

RCV-RD0201N-25

Reszon COVID-19 Rapid Antigen Test (Nasal Swab)

Nasal Swab

Cassette

Coronavirus disease
COVID-19

4-30℃

25 T/ Kit

To be updated