Information and Awareness about the Diagnostic kits (COVID)

Diagnostic kits COVID allow an individual to swab the front part of the nostril and may be used on children (supervised by an adult) as well as adults. Specimens are shipped overnight via FedEx
at room temperature (without a frozen cold pack).

Specimens collected using the Diagnostic kits (COVID) may be tested with the Quest Diagnostics SARS-CoV-2 RT-PCR test that received an Emergency Use Authorization in March. RT-PCR testing aids in diagnosing infection with SARS-CoV-2, the virus that causes COVID-19.

• Operon Strategist is FDA 510 k process consultant helps the clients to register SBU (Small Business Unit), if applicable.
• Take out the testing requirement of the product, creation of the dossier, resolving the queries and after completion of all the activities, the client receives the US FDA 510 k approval.
• We also assist with the establishment registration and device listings to make suitable the supply of medical devices in the US.

Specimens collected using the Diagnostic kits (COVID) may be tested with the Quest Diagnostics SARS-CoV-2 RT-PCR test that received an Emergency Use Authorization in March. RT-PCR testing aids in diagnosing infection with SARS-CoV-2, the virus that causes COVID-19.

“COVID-19 molecular diagnostic testing has been constrained partly by limited supplies of swabs and trained healthcare professionals to do the specimen collection,” said Steve Rusckowski, Chairman, CEO and President. A diagnostic kits (COVID) enables an individual to self-collect at home, and the process is far less invasive and uncomfortable than many traditional methods.”

Demand for Co-Diagnostics products Diagnostic kits (COVID)  or the has soared since the FDA granted it an emergency use authorization (EUA) to sell the Logics Smart COVID-19 test on April. The Centres for Medicare and Medicaid Services (CMS), which regulates all U.S. laboratory testing performed on humans, has also approved the sale of the test to roughly 260,000 clinical laboratories across the country. 

What are Diagnostic kits COVID ?

This test kits are used for testing patients specimens for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19.

Importing diagnostic kits COVID

Upon receipt of satisfactory report from ICMR / NIV / any other duly authorised testing institutes, the developer is required to apply for a licence to import/ manufacture such COVID-19 test kits for the purposes of Import/ Manufacture for sale or distribution within India. 

Covid diagnostic kits Approvals

The Diagnostics kits COVID clinical performance evaluation such performance evaluation is done for compliance with existing testing standards that are set by the ICMR.

Read More - Diagnostic kits COVID 

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