Rapid test for detection of SARS-CoV-2 Antigen in human nasal swab and nasopharyngeal swab specimens(PerkinElmer COVID-19 Antigen Test ) - India CDSCO Medical Device Registration
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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Brand Name
CA 15-3
Device Class
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
Rapid Test for Malaria Pv/Pf
Brand: CA 15-3
ZEPHYR BIOMEDICALS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED
Rapid Test for Malaria PAN/Pf
Brand: CA 15-3
ZEPHYR BIOMEDICALS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED
Rapid Test for Malaria PAN
Brand: CA 15-3
ZEPHYR BIOMEDICALS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED
Rapid Test for Syphilis (SYPHICHECK )
Brand: CA 15-3
ZEPHYR BIOMEDICALS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED
Enzyme Linked Immunosorbent Assay for the Quantitative Determination of Ovarian Cancer Antigen in Human Serum
Brand: CA 15-3
ZEPHYR BIOMEDICALS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED
Enzyme Linked Immunosorbent Assay for the Quantitative Determination of Alpha Feto Protein in Human Serum
Brand: CA 15-3
ZEPHYR BIOMEDICALS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED
Fluorescence Immunoassay for Quantitative detection of Prostate Specific Antigen in Human Serum/Plasma
Brand: CA 15-3
ZEPHYR BIOMEDICALS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED
Chemiluminescence Assay for the Quantitative Determination of Ovarian Cancer Antigen in Human Serum
Brand: CA 15-3
ZEPHYR BIOMEDICALS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED
Enzyme Linked Immunosorbent Assay for the Quantitative Determination of Breast Cancer Antigen in Human Serum
Brand: CA 15-3
ZEPHYR BIOMEDICALS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED
Fluorescence Immunoassay for Quantitative detection of Cardiac Troponin I in Human Serum/Plasma
Brand: CA 15-3
ZEPHYR BIOMEDICALS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED
Rapid Test for Malaria Pv/Pf
Brand: CA 15-3
Rapid Test for Malaria PAN/Pf
Brand: CA 15-3
Rapid Test for Malaria PAN
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