Rapid test for detection of SARS-CoV-2 Antigen in Human Nasal Swab Specimen at Home (COVIRAT HOME TEST ) - India CDSCO Medical Device Registration
Rapid test for detection of SARS-CoV-2 Antigen in Human Nasal Swab Specimen at Home (COVIRAT HOME TEST ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000043_baa4f71d4d7acb5ecea786c30cc244e9_ef730832ffda703742369f5b1075dfbe. This device is marketed under the brand name CA 15-3. The license holder is ZEPHYR BIOMEDICALS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is Sub Zonal Goa.
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Brand Name
CA 15-3
Device Class
Approving Authority
Sub Zonal Goa
Product Information
CoviRAT Home Test is an in-vitro, rapid, qualitative immunoassay for the detection of nucleocapsid protein antigens expressed by the SARS-CoV-2 virus present in human nasal swab specimen. This test is authorized for non-prescription home use with self-collected nasal swab specimens from individuals aged 18 years or older or adult-collected nasal swab specimens from individual aged 8 years or older who are suspected of COVID-19 within the first six days of the onset of symptoms. CoviRAT Home Test does not differentiate between SARS-CoV and SARS-CoV-2. It is to be used for screening or to aid in the diagnosis of COVID-19 disease. This rapid antigen detection test takes 15-20 minutes for producing a positive or negative test result. SARS-CoV-2 antigen is generally detectable in anterior nasal specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, therefore a positive result with CoviRAT Home Test should be considered as true positive and need not be confirmed with an RT-PCR test. Individuals who test positive with CoviRAT Home Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary and for public health reporting. Symptomatic individuals who test Negative with CoviRAT Home Test and if they continue to experience COVID19 like symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should immediately get themselves tested by RT-PCR. In the meantime such individuals will be urged to follow home isolation and seek follow up care with their physician or healthcare provider. All prescribing healthcare providers will report all test results they receive from individuals who use this authorized product to relevant public health authorities in accordance with the local or state government requirements. This test is suitable for the following people: Adults aged 18+: Self-test and report, with assistance if needed. Adolescents aged 12 – 17: Self-test and report with adult supervision. The adult may conduct the test as necessary. Children between 8 - 12: Children in this age group should be tested by an adult. Do not conduct this test if you do not feel confident testing a child. Do not continue the test if the child feels any pain.
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ZEPHYR BIOMEDICALS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED
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Brand: CA 15-3
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Brand: CA 15-3
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Brand: CA 15-3
Rapid Test for Syphilis (SYPHICHECK )
Brand: CA 15-3
Enzyme Linked Immunosorbent Assay for the Quantitative Determination of Ovarian Cancer Antigen in Human Serum
Brand: CA 15-3
Enzyme Linked Immunosorbent Assay for the Quantitative Determination of Alpha Feto Protein in Human Serum
Brand: CA 15-3
Fluorescence Immunoassay for Quantitative detection of Prostate Specific Antigen in Human Serum/Plasma
Brand: CA 15-3
Chemiluminescence Assay for the Quantitative Determination of Ovarian Cancer Antigen in Human Serum
Brand: CA 15-3
Enzyme Linked Immunosorbent Assay for the Quantitative Determination of Breast Cancer Antigen in Human Serum
Brand: CA 15-3
Fluorescence Immunoassay for Quantitative detection of Cardiac Troponin I in Human Serum/Plasma
Brand: CA 15-3