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The Diagnostic Kit
(Colloidal Gold ) for IgG/IgM Antibody to SARS-COV-2
A rapid immunoassay
for the qualitative detection of antibodies (IgG
and IgM) to SARS-COV-2 virus in Whole Blood/Serum / Plasma.
Kit Components
*Individually packed test devices 25 tests/kit
*Buffer 1 vail/kit
*Disposable pipettes 25 kit
*Package insert 1 copy/kit
FDA Certified
EU Certified
FDA approved COVID-19 tests
FDA approved COVID-19 tests
The Coronavirus has turned into a pandemic all over the world. Millions of people are affected, and lakhs of infected people are deceased due to the deadly infection of Covid-19. The toll of death and infection is spiking the highest graph in the United States. Recently, the US Food and Drug Administration or FDA has authorized a new type of covid-19 test in the United States. Using this new type of test kits, the patients can collect their samples at home. An organization named LabCorp innovated a test kit called Pixel. Using Pixel, the affected people can manage their samples and send them to the laboratory for testing. Upcoming week onwards, these
self-using test kits will be available to all consumers.
COVID-19 tests
FDA Commissioner Dr. Stephen Hahn says that to facilitate the testing purpose among the citizens, Pixel will be available in the market. Without the help of any medical expert, a common man can ensure whether he or she is affected with Coronavirus. This process is considered to be the most reliable and convenient test kit option for every household. This week, the US witnessed a massive growth of infection and death. Without the self-testing, it is also challenging to test every individual, whether they are affected by Corona symptoms. In many cases, the symptoms of Corona are not revealed among the infected. Naturally, it is difficult to point out a virus-carrier individual.
FDA COVID Tests
Since the outbreak of this pandemic, FDA is working round the clock, and they have permitted more than 50 diagnostic tests and engaged with more than 350 test developers. FDA is closely working with LabCorp to lucid the process of home sample collection and the proper demonstration of the process for the accurate supply chain function for the sample collection at the hospital or the health center. With the successful test kit and process functionality, the patients are also safe and comfortable to check their sample while staying indoor. Pixel, the LabCorp test kit, consists of a nasal swab to collect the sample with the self-service. As per the company website, the price of the test kit is $119.
FDA has also announced that the emergency use of authorization applies for the LabCorp Covid-19 test kits, which contain the nasal swab to collect the specimen for the testing from home to the nearest medical center.
Previously, in March, the Coronavirus diagnostic test was authorized by a health care provider for emergency purposes. Adam Schechter, the president and CEO of LabCorp, mentions that the test kit is a huge success to test millions by saving a lot more time, and this is the most effective, accurate, and safe way to identify the Corona-affected people with the less chance of spreading the infection.
The present growth of infection in the US has shattered socio-economic growth. In this crucial time, there is a massive pressure in the health sector and medical practitioner to identify and cure the affected Corona-patients. The infection is spreading so fast that the healthcare system of any country is not sufficient to test every individual and isolate the affected. Under these circumstances, the citizens need to be more responsible and must have the power of FDA approved COVID-19 tests kits to reduce the infection. The new kit Pixel is the first success stone against the Coronavirus war.
FDA approved COVID-19 tests in bulk
FDA approved COVID-19 tests in bulk
There is a significant development in Coronavirus test kits in the United States. The U.S. Food and Drug Administration has approved the first self-test kit for Coronavirus pandemic. The test kit, called Pixel, developed by LabCorp is quite convenient for the U.S. citizen to test at home. It is expected that the test kit will bring a revolutionary change in the virus testing at-home process. A few months back, the Coronavirus outbreak started in Wuhan city, China. Within months, the virus outbreak has taken over the whole world. The world economy is shattered. The virus causes respiratory disease, which sometimes is leading to death. This flu-like infection is quite contagious and affects more than 2 million people all over the world. The death toll has reached 2 lakhs and is leaping high every day.
Buy COVID-19 Tests
The rapid infection process of the virus has destined the public health in a critical condition. The health care system is struggling to cope up with so many affected. The rapid test has become impossible with the limitation of health care practitioner numbers in the country. Due to the infectious nature of the virus, social distancing is the mandate to reduce the rate of infection. Under these circumstances, the Pixel is a significant relief for the U.S. citizens to maximize the test and select the infected people. In this self-testing process, FDA approved COVID-19 tests in bulk is possible in a short period and less workforce. Maximize the number of testings to identify the number of affected and isolate those.
The process will limit the spreading of the infection quickly. According to the new FDA policy, few laboratories are authorized to begin validating Covid-19 diagnosis. Before the completion of the Emergency Use authorization (EUA) request by the FDA, the labs are activated as per the gravity of the situation. As it is a case of a national emergency, the FDA allows medical products, useful in diagnosing, treating, or preventing the
rapid spreading of the pandemic in the United States.
How Can I But COVID Tests
LabCorp has multiple networks of medical laboratories in the country. In the United States, the test kit is available at $119. This test can be done under any medical expert supervision. After using the test kit, the individual can mail the report to the medical lab. Under the guidance of a licensed medical expert, the result of the test will be analyzed, and the final report depicts whether the result is positive. The test kit consists of a nasal swab by which an individual can collect the sample of the swab and test the same.
Rapid detection and diagnosed with Covid-19 is the priority for the FDA. It is a high chance for the Government to control the rapid spreading of respiratory illness. As per the FDA guidance, the laboratory has the authority to conduct quick tests. They also must have rapid testing capacity to control the outbreak. The rate of infection in the U.S. has collapsed the socio-economic growth. Under these critical circumstances, the health sector and medical practitioner are facing tremendous stress to identify and cure the affected Corona-patients. The contagious nature of the virus has stupefied the healthcare system of any country. In many cases, the infrastructure is not sufficient to test every individual and isolate the affected. In this situation, the U.S. citizens are expected to be more responsible and use the test kits to identify the infection. The Pixel will be the first pillar of success against the Coronavirus war.
Buy FDA Approved COVID-19 Tests In Bulk
Buy FDA Approved COVID-19 Tests In Bulk
There is a significant development in Coronavirus test kits in the United States. The U.S. Food and Drug Administration has approved the first self-test kit for Coronavirus pandemic. The test kit, called Pixel, developed by LabCorp is quite convenient for the U.S. citizen to test at home. It is expected that the test kit will bring a revolutionary change in the virus testing at-home process. A few months back, the Coronavirus outbreak started in Wuhan city, China. Within months, the virus outbreak has taken over the whole world. The world economy is shattered. The virus causes respiratory disease, which sometimes is leading to death. This flu-like infection is quite contagious and affects more than 2 million people all over the world.
The death toll has reached 2 lakhs and is leaping high every day. The rapid infection process of the virus has destined the public health in a critical condition. The health care system is struggling to cope up with so many
affected. The rapid test has become impossible with the limitation of health care practitioner numbers in the country. Due to the infectious nature of the virus, social distancing is the mandate to reduce the rate of infection. Under these circumstances, the Pixel is a significant relief for the U.S. citizens to maximize the test and select the infected people. In this self-testing process, FDA approved COVID-19 tests in bulk is possible in a short period and less workforce. Maximize the number of testings to identify the number of affected and isolate those.
The process will limit the spreading of the infection quickly. According to the new FDA policy, few laboratories are authorized to begin validating Covid-19 diagnosis. Before the completion of the Emergency Use uthorization (EUA) request by the FDA, the labs are activated as per the gravity of the situation. As it is a case of a national emergency, the FDA allows medical products, useful in diagnosing, treating, or preventing the rapid spreading of the pandemic in the United States. LabCorp has multiple networks of medical laboratories in the country. In the United States, the test kit is available at $119. This test can be done under any medical expert supervision.
After using the test kit, the individual can mail the report to the medical lab. Under the guidance of a licensed medical expert, the result of the test will be analyzed, and the final report depicts whether the result is positive. The test kit consists of a nasal swab by which an individual can collect the sample of the swab and test the same. Rapid detection and diagnosed with Covid-19 is the priority for the FDA. It is a high chance for the Government to control the rapid spreading of respiratory illness. As per the FDA guidance, the laboratory has the authority to conduct quick tests. They also must have rapid testing capacity to control the outbreak.
The rate of infection in the U.S. has collapsed the socio-economic growth. Under these critical circumstances, the health sector and medical practitioner are facing tremendous stress to identify and cure the affected Corona-patients. The contagious nature of the virus has stupefied the healthcare system of any country. In many cases, the infrastructure is not sufficient to test every individual and isolate the affected. In this situation, the U.S. Citizens are expected to be more responsible and use the test kits to identify the infection. The Pixel will be the first pillar of success against the Coronavirus war.
FDA Approved COVID-19 Tests wholesale The U.S. Food and Drug Administration department is aggressively taking all possible courses of action to harness the situation due to the Coronavirus outbreak in the states. With the do-or-die approach, the FDA is authorizing specific laboratories to develop diagnostic tests for Coronavirus affected people. The sole concern is to improve the number of rapid tests to control the rapid growth of the virus outbreak. In the dynamic, evolving, and critical situation, the FDA wants to fulfill the commitment and responsibility for public health.
The outbreak of Coronavirus started in Wuhan city, China. The virus is responsible for respiratory diseases, and in many cases, the condition leads to death. WHO has detected more than 50 locations internationally, including the U.S., where the virus outbreak has turned into a menace. The public health issue impacts the world economy, and the growth of GDP precipitated 100 years lower. Covid-19 has the capacity for rapid infection, and it influences the health system of the country with a critical impact. The virus is considered as a potential health threat for the public, and the compels to maintain social distancing to repel massive community spread. To some extent, the virus manages community infection in the U.S. and Europe, and the enormous number of infections are challenging to identify and quarantine. With the intervention of the FDA, the local medical enters also have a significant role in executing the test and examining the test result to identify the affected. In the new policy by the FDA, certain laboratories are authorized to begin validating Covid-19 diagnostic.
Before the completion of the Emergency Use Authorization (EUA) request by the FDA, the labs are activated as per the gravity of the situation. With the basis of some scientific data, FDA is permitting the medical products which are effective in diagnosing, treating, or preventing the outbreak of the Coronavirus. This is the case of a national health emergency for U.S. citizens. Rapid detection and diagnosis with Covid-19 have become the utmost priority for FDA and Government to rein the rapid spreading of respiratory illness. As per the guidance of the FDA, the laboratory has the authority for the immediate test, and they must have the rapid testing
capacity to control the outbreak. LabCorp, a private organization, has introduced a test kit called Pixel.
Pixel is a self-used test kit that can be used by the public for the swab test. Presently, FDA Approved COVID-19 Tests kits wholesale, which become in high demand in the United States. The test kit consists of a nasal swab by which any individual can test whether they are affected by Coronavirus. Once the test is done, a local laboratory or health can collect the kit and send the specimen for the analysis. Reducing the medical practitioners’ direct involvement, the process multiplies the number of tests and identifies the affected people for emergencies. As per the guidelines, the laboratories have to communicate with the FDA by email within 15 days of the testing with the medical report. They have to submit a completed EUA request within 15 business working days. FDA being an agency of the U.S. Department of Health and Human Services has a principal operation goal on the safety and security of public health. They continuously monitor human and veterinary drug quality control. The agency is also responsible for checking the quality of food, medical instruments, dietary supplement, cosmetics, and other radiation instruments for human welfare.
US FDA and COVID Testing
The U.S. Food and Drug Administration approved the initial diagnostic evaluation with a house set as an alternative for COVID-19. The FDA’s around-the-clock work because this outbreak started has caused the authorization of over 50 diagnostic assessments and involvement with over 350 evaluation programmers. Especially since they worked to guarantee the information shown from an individual sample set
that was at-home is accurate and as secure as a sample group in the hospital, a physician’s office or website. This reissued EUA for the molecular evaluation of LabCorp allows testing of a sample collected from the individual’s nose with a designated kit which has saline and swabs. After patients’ self-swab to accumulate their sample, they email their sample to some LabCorp laboratory for testing, in a bundle. LabCorp plans to create the Pixel from LabCorp COVID-19 Test house collection kits in the forthcoming weeks, with a physician’s order. The LabCorp house self-collection kit involves a particular cotton swab for individuals to use to accumulate their sample. Due to issues with sterility and swabs, cotton swabs that were other shouldn’t be used for this evaluation at the moment. The FDA continues to work to ascertain whether Q-tip-style cotton swab may be used safely and efficiently using different assessments. This consent applies for the Pixel being used by an assortment of swab specimens from FDA approved COVID-19 tests kits.
It’s necessary to be aware that this isn’t general permission for evaluations conducted in-home, or for an assortment of samples with assessments, media, or group swabs. The bureau is accountable for security and the safety of the country’s food supply, cosmetics products, which give radiation off, also.
FDA approved Covid-19 tests
FDA approved Covid-19 tests
U.S. Food and Drug Administration has authorized the home-based test for Covid-19 for U.S. citizens. Through this process, the testing procedure can be fast, and human resources will be limited. Earlier, before the home testing kit was available, every affected individual had to visit the nearest health centre for Covid-19 tests. In the process, there is a high chance to spread the infection among the people, and the health experts are outnumbered with the affected cases. In the present scenario, the home-based test will reduce the spreading of the infection.
FDA is responsible for –
- FDA is monitoring the protection of human life by quality control checks of medicine and medical products.
- If there is any electronic product radiation is affecting growth, FDA intervenes into it.
- FDA is a strict regulatory body to control tobacco products.
- If there is any requirement for a medical emergency for human life, the FDA offers its support for medical innovation.
A few months back, Coronavirus affected Wuhan city, China. Though the source of the virus is still controversial, it is assumed that through bats, the virus was generated. The mortality rate of Coronavirus may not be alarming, but the rate of infection has made the virus a terror of the world. Within two months, more than eighty thousand people in China were infected with the virus, and more than three thousand people are dead. The next epicentre of the virus attack was in Europe, and more than millions are affected by this virus. Though the mortality rate is low due to the highly contagious nature, the death toll in Europe becomes alarming. Countries like Italy, Spain, France, Germany, Netherland and other witnesses suffer thousands of deaths and infection. The economy is devastated. The next epicentre of Coronavirus is the United States. Till now, more than one million people are affected, and sixty thousand people are dead. The healthcare infrastructure is in jeopardy, and the infection rate is leaping high.
Under these circumstances, the self-testing kit is a significant relief for the U.S. Food and Drug Administration. The test kit, called Pixel, is developed by LabCorp. The test kit consists of a nasal swab and saline. In the self-tested kit, a user has to use the nasal swab to collect the sample and mail it to the nearest medical centre for a check-up. After the test, the medical experts will mail back whether the sample would come as positive.
Through the test of analyzing the swab, the medical experts find the antibody in human blood. If there is any virus in the human body, the auto defence system tries to immune the body against the virus. In the process, a new breed of antibody is generated in the human body if he can survive through the virus attack. The plasma of that individual has the immunity to protect against the virus. In many cases, the plasma is used as the medicine to protect the affected against the infection.
FDA approved Covid-19 tests are always showing a ray of hope. This self-testing kit has reduced the probability of infection and side-by-side the reduce the intervention of the medical practitioners to test and collect the test samples. Presently, in the U.S., FDA approved test labs are authorized to examine the swab sample. Hope the process can improve the pace of health service in this pandemic outbreak.
FDA approved COVID-19 tests
FDA approved COVID-19 tests
A new initiative has been taken by the U.S. Food and Drug Administration by ensuring the availability of the FDA approved Covid-19 test kit in every household. They have authorized the same for U.S. citizens only. In this process, using the test kit, any individual can test whether they are affected with infection. This process will improve the speed of testing by minimizing the medical expert’s direct association. Before the sanction of the process, the infected citizen has to travel to the nearest medical centre for the testing. There may be the possibility of spreading the infection while the person is travelling. In both ways, FDA approved Covid-19 test kits are beneficial to resist further infection possibility among the U.S. citizens.
What does FDA do –
- FDA is monitoring dietary supplements, bottled water quality and food additives.
- FDA tracks the transaction of prescription and non-prescription drugs.
- If there is any electronic product radiation is affecting life, FDA intervenes into it.
- FDA is a governing body who monitor and control the medicine and the medical product directly associated with human life protection.
- FDA monitor and can intervene if there is any electrical device affecting human life by radiation
- For the tobacco and the tobacco products, the FDA keeps its close vigil.
- If human life requires any urgent medical support for an emergency, the FDA supports medical innovation with all the support.
In December 2019, a Coronavirus outbreak was started in Wuhan city, China. There is some controversy about the source of this virus. As per many expert’s opinions, the source of the virus is from bats. Once it is affected by the human body, it starts incubating until 15 days. In this period, the human can spread the infection through sneeze or cough. In the present research, it is found that the virus can travel to 4 metres through a cough or spit from the affected person. As per the WHO guidelines, social distancing is a must to resist the infection spreading. It is essential to cover the mouth, nostrils and eyes to reduce the possibility of infection. If the human is suffering from any diseases of lungs, heart or liver previously, the virus can affect critically. After the virus outbreak in Wuhan, there were more than eighty thousand people infected and three thousand died. The next epicentre of the virus was in Europe. Millions of people are infected in European countries like Italy, Spain, France, Netherland, Germany etc. Simultaneously, the virus affected the United States. Till now, as per the infection and death, the U.S. tops the list. More than one million people are infected, and the death toll has surpassed more than sixty thousand.
In this situation, FDA approved home test kits are very useful for home testing. The test kit is called Pixel. It is an innovation of LabCorp. In the test kit, there is a nasal swab and saline. Using the swab, the individual can collect the sample of his/her swab and mail it to the FDA authorized medical centre. Once the medical experts have tested the sample, they will mail back the report. In this process, without the direct association of medical experts, everyone can check at home.
In present times, the human race faces an imminent danger for its existence. The whole world is united to fight against this pandemic. FDA’s effort with this self-test kit is a milestone of success.
FDA approved Covid-19 test kits
FDA approved Covid-19 test kits
The United States is affected severely due to the outbreak of Coronavirus. The rhyme of life has been paused, witnessing a graph of death in the United States. Various industries incur a massive loss for this pandemic outbreak. Among the other sectors, the travel industry is profoundly affected. Ancillary industries related to travel like airlines, car rent, hotel etc. have faced a tremendous loss of revenue. People are compelled to stay safe inside the home, and the natural fear of infection starts blurring the future of the travel industry for quite a long distant period.
In December of 2019, the virus outbreak started in Wuhan city, China. Still, the source of the virus is controversial. As per many experts, bats are the reason for Covid-19. Many European nations have alleged China for the artificial creation of Corona in the laboratory. In the first few months, China was severely affected with Coronavirus – more than eighty thousand people are infected, and three thousand died due to the infection. The Coronavirus spread the tentacle in Europe – Italy, France, Germany, Spain etc. countries are the worst affected. Simultaneously, the disease started in the United States. So far, America is the most severely affected country. More than a million are infected, and sixty thousand people are dead in the pandemic outbreak.
The snapshot of the graph is changing every day, as the virus spreads and infects thousands of U.S. citizens every day. World Travel and Tourism Council, representing major global travel companies, forecasts that if the virus continues spreading in the next few months, there may be a massive loss of $2.1 trillion revenue and 75 million jobs all around the world.
Various airlines companies all across the world have leaned off after a colossal job-cut, and some are already shut down. The upcoming calamity of job-losses will jeopardize millions of family in the travel industry. The American travel industry forecasts 4.6 million job losses in May. The halo of tourism has extinguished in the illuminating life of Las Vegas casinos and luxury hotels.
On the 29th of March, the President of the United States attempted to contain the virus by encouraging social distancing and limiting the gathering. May and June’s months are the most significant month for the U.S. travel industry, and unfortunately, the virus outbreak is considered to be the maximum during the period. Naturally, the industry loses a significant amount of revenue. The CEO U.S. Travel Association claims that the damage is more than six to seven times more massive than the 9/11 terrorist attack in the U.S. Under the circumstances, Congress has passed a $2 trillion stimulus to aid those people and their families in this economic challenge of the travel industry. But the question is whether the amount is sufficed to fulfil the loss.
Due to the rate of infection and death, the health system in the U.S. is facing a strong challenge due to the human resources in the medical field. Presently, FDA approved Covid-19 test kits are available for self-testing. The good news is that with this innovation of the self-test kits, testing is done rapidly and the economy will come back to the rhythm, as the citizens can defy the rate of infection.
As the travel and tourism industry is hit and the process may continue a few more months, there is only the hope to bring back healthy life into the track. Savings for the rainy day will help to survive in the period, and sunshine will surely bless mankind again.
FDA Approved COVID-19 Tests
FDA approved COVID-19 tests
The Drug and Food Administration is in charge of telling us that drugs, foods, and medical devices are safe for all of us to utilize. If we blindly believe that all the approved products have been analyzed, that is not correct. There is a significant distinction between medication or medical devices that has been FDA accepted and the ones that are FDA approved. Given that the FDA is getting more and more technology goods, it is crucial to comprehend the difference between ‘FDA accepted’ and “FDA approved”. The phrase “FDA Approved” means that the bureau has decided that the “benefits of the product outweigh the dangers for its intended usage.”
When choosing to accept a product or medication, the FDA must determine if the dangers are outweighed by the advantages. The FDA is inclined to approve an item that has a risk if the advantage is significant — such as an artificial heart valve which may save the life of someone or the test kit of Covid-19, which can save millions of affected lives.
FDA is responsible for:
- Protecting human life by the assurance of the medicine and medical products are correctly quality checked. That vaccine, drug, or medical devices are safe to use.
- Protecting the general public from the radiation of any electronic product.
- Tobacco product regulation
- Speed up product innovation, especially for human welfare, for any critical emergency.
Background Tests detect antibodies present in the bloodstream once the body is reacting to a particular infection. They discover the body’s immune response to the disease. Experience with viruses indicates that people whose blood includes antibodies are not infected with the virus and are recovered –might have the ability to resume daily tasks and work. They might be qualified to serve as donors of plasma.