CDSCO UID MFG/IVD/2020/000043_9c6cdc17acf46c3d4aae143541ef05e1_e204164e8ec507e27af345e632fa0498
Rapid test for detection of SARS-CoV-2 Antigen in human nasal swab and nasopharyngeal swab specimens(PerkinElmer COVID-19 Antigen Test )
ZEPHYR BIOMEDICALS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED·Device Class Class C·India CDSCO·Brand: CA 15-3
Registration details
- UID
- MFG/IVD/2020/000043_9c6cdc17acf46c3d4aae143541ef05e1_e204164e8ec507e27af345e632fa0498
- Device class
- Class C
- Brand name
- CA 15-3
- Approving authority
- Sub Zonal Goa
- Product information
- PerkinElmer COVID-19 Antigen Test (CA 15-3) is an invitro, rapid, qualitative immunoassay for the detection of specific antigens expressed by the SARS-CoV-2 virus present in human nasopharyngeal swab and nasal swab specimens. It is to be used for screening or to aid in the diagnosis of COVID-19 disease and exposure to the virus. This rapid antigen detection test takes 20-30 minutes for producing a positive or negative test result. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or other management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. The result of this test should not be the sole basis for the diagnosis. Presumptive positive or negative result with the Rapid Antigen. Test may need to be further confirmed with a molecular test, as needed
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About this record
Rapid test for detection of SARS-CoV-2 Antigen in human nasal swab and nasopharyngeal swab specimens(PerkinElmer COVID-19 Antigen Test ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000043_9c6cdc17acf46c3d4aae143541ef05e1_e204164e8ec507e27af345e632fa0498. 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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