Rapid Test for detection of SARS-CoV-2 Antigen in human nasal swab and nasopharyngeal swab specimens [CASSETTE TEST] (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 [CASSETTE TEST] (PerkinElmer COVID-19 Antigen Test ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000130_5d76247c484ce3e314c56551c0d6b088_9cb3744b75a3fae84a71e9ebde5cf299. This device is marketed under the brand name Paracheck Pf Device. The license holder is VIOLA DIAGNOSTIC SYSTEMS - A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED,, and it is classified as Device Class Class C. The approving authority is CDSCO -North Zone, Ghaziabad.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

CDSCO Registered

Class Class C

Rapid Test for detection of SARS-CoV-2 Antigen in human nasal swab and nasopharyngeal swab specimens [CASSETTE TEST] (PerkinElmer COVID-19 Antigen Test )

UID: MFG/IVD/2020/000130_5d76247c484ce3e314c56551c0d6b088_9cb3744b75a3fae84a71e9ebde5cf299

Brand Name

Paracheck Pf Device

License Holder

VIOLA DIAGNOSTIC SYSTEMS - A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED,

Device Class

Class C

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

PerkinElmer COVID-19 Antigen Test (Paracheck Pf Device) is an invitro, rapid, qualitative immunoassay for the detection of nucleocapsid protein 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. This rapid antigen detection test takes 15-30 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 may need to be further confirmed with a molecular test