FDA EUA authorized - COVID-19 Rapid Antibody Test Kits

Our COVID-19 Antibody Test Kits

Our COVID-19 antibody test kits are the most effective rapid results test on the market.

Our kits:

Are FDA EUA authorized
Provide rapid results in 10 minutes
Can be sold in small sample sizes of 20 or 100 per pack
Can be purchased in large quantities up to 1 million kits
Have a 9-month shelf life
Proven high sensitivity for current infection of the virus.
Require a verification of use case prior to shipping is mandatory

‪(888) 996-3335‬

COVID-19 Test Kit Contact Request Form

PLEASE NOTE THIS IS NOT FOR INDIVIDUAL PURCHASE OR USE. THIS IS STRICTLY FOR BUSINESSES AND GOVERNMENTAL ORGANIZATIONS.

If you are an individual looking to be tested please visit our telemedicine providers

AVAILABLE

We have COVID-19 antibody test kits ready to ship today!

Eliminate the worry of a potential COVID-19 outbreak in your office today. Medek offers FDA EUA authorised COVID-19 test kits that can shipped out today via UPS ground or overnight. Get your order in today by 1 p.m. EST, and your COVID-19 test kits will ship today.

ACCURATE

Due to rigorous testing, our COVID-19 10-minute rapid test kits have a high sensitivity for the current strains of infection of the virus. Our tests are proven to be reliable and accurate (Clinical evaluation: Positive Percent Agreement (PPA): IgG 96.7%; IgM 86.7%; Overall 96.7%, Negative Percent Agreement (NPA): IgG 98.0%; IgM 99.0%; Overall 97.0%, Clinical Agreement with Characterized Samples: Sensitivity: IgG 96.7%; IgM 100%; Combined 100%, Specificity: IgG 97.5%; IgM 100%; Combined 97.5%).

Our COVID-19 rapid test kits are FDA EUA authorized. Our serology tests detect for antibodies of the virus (IgG) and current COVID-19 infection (IgM). You will have all the resources you need to help keep COVID-19 at bay for your business, medical practice, or government facility.

AFFORDABLE

We work directly with the manufacturer which helps us to be able to offer COVID-19 antibody test kits at a much lower cost than any of our competitors

We partner with organizations of all sizes from small businesses to enterprise-level organizations, ensuring they have the proper supply of COVID-19 antibody test kits they need in a timely manner.

The larger the order, the lower cost per unit.

Let Medek be your testing partner

We’re not just selling COVID-19 antibody test kits, we’re partnering with organizations to ensure they have the best results with their COVID-19 antibody test kits.

If you order more than 10,000 kits, we will utilize our expertise in the healthcare industry to help map out the logistics for testing and how to safely coordinate positive tests.

We can even provide medical teams to administer tests for your company.

By offering Medek you can lower your healthcare costs, increase productivity, help recruitment, reduce “sick” days, and increase retention.

Order Now!

Medek Health is an authorized dealer of COVID-19 antibody test kits, bringing to your business, organization or government the most accurate COVID-19 antibody test kit at the most affordable rate available on the market.

COVID-19 Test Kit Direct Contact:

‪(888) 996-3335‬

COVID-19 Test Kit Contact Request Form

COVID19 IGG / IGM Rapid Test Kit

To support public health and safety we are offering a proven cost effective FDA EUA authorized coronavirus test kit to help stop the spread of coronavirus.

FDA EUA Authorized
Rapid results in 10 minutes
Small sample sizes
Sold in packs of 20
9 month shelf life

Order Now!

Additional Resources

Additional Notices

This test has not been FDA cleared or approved;
This test has been authorized by FDA under an EUA for use by authorized laboratories;
This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Medek Health offers 2 types of COVID19 IGG / IGM Rapid Test Kits please note that the Healgen COVID19 IGG / IGM Rapid Test Kits can only be used in Laboratories certified under the Clinical Laboratories Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a to perform moderate or high complexity tests.
Warning
This test has been authorized by FDA under an EUA for use by authorized laboratories.
This test has not been FDA cleared or approved.
This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
This product is intended for professional use and not for home use.
Not for the screening of donated blood.

General Information

FDA EUA Authorized COVID19 Test Kits Limitations of Sale:

● Rapid results in 10-15 minutes
● Sold in packs of 20 or 100
● Shelf life of 9 months from manufacture date
● For use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection
● Verification of use case prior to shipping is mandatory

Governance for COVID19 Test Kits

A. Authorized by the Food and Drug Administration (“FDA”) on May 29, 2020 for detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in venous whole blood, plasma, or serum.
B. Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency issued on the web on March 16, 2020 by U.S. Food and Drug Administration (FDA”) which may be found here https://www.fda.gov/media/135659/download (collectively the “Policy”);
C. The Policy provides guidance on the emergency use of products for Covid 19 tests in this declared emergency, and provides authority to provide Covid 19 Rapid Cassette IgG/IgM tests (“Products”) and submitted an Emergency Use Authorization to the FDA in compliance with the Policy;

Compliance

A. All sales of Products are subject to the purchaser’s compliance with the Policy and that the Products shall only be used by health professionals as defined in subsection (g) at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=810.2;
B. The Products are only for preliminary screening purposes and shall only be used to determine if additional testing is required

Buyer Requirements

A. Qualified parties who agree to follow the guidance in the Policy including, but not limited to, validation, FDA notification, reporting of results, Emergency Use Authorization, clinical testing and distribution

Frequently Asked Questions

1What is the minimum order size for Covid Test Kits Orders?

The minimum order size of purchase is 20 tests and are sold in multiples of 20.

2Can I buy Covid Test Kits for my business?

Yes. As a business owner you may purchase Covid19 test kits and administer them for surveillance usage. It is required that a medical professional administers the test. You must follow all CDC and FDA guidelines. For clinical usage only, we offer Healgen tests, which are not available to businesses.

3Where can I purchase Covid Test Kits for my business?

You can purchase Covid19 Rapid Antigen or Antibody Test Kits directly from Medek Health.

4How do I receive my Covid Test Kits?

We ship all tests directly from the manufacturer to the address of your choosing.

5How long does it take to receive Covid Test Kits?

Shipment time depends where you would like your tests shipped and the quantity of your order. Standard shipping times apply.

6How much is a Covid-19 Rapid Test Kit for my business?

Antibody Test Kit pricing ranges from $15 - $22 depending on the size of the order. But we cannot sell to individuals.

7What is a Covid19 antibody test?

A Covid19 antibody test checks your blood for antibodies. If you have antibodies in your system you either have Covid19 or have had Covid19. The most common type of antibody test is a lateral flow test that uses a blood sample and a buffer inside a cassette to determine if you have Covid.

8How does a Covid19 Antibody test work?

A blood sample is collected with the mini plastic dropper (provided with the test kit) and transferred to the test cassette sample well. Several drops of buffer solution are added to the buffer well on the test cassette and then the result is read in 10-minutes.

9How accurate is a Covid19 antibody test?

Test accuracy can vary depending on the manufacturer of the test. Medek Health is a distributor of 2 FDA Authorized Covid-19 IgG/IgM Rapid Test and one has a higher IgM sensitivity then the other.

10Are all Covid 19 antibody tests the same?

While all antibody tests may have a similar look and input elements, accuracy levels may vary depending on the manufacturer. The FDA has authorized certain manufacturers who have met quality standards to distribute their test. Even so, accuracy may vary.

11How long does it take to know if I have Covid19 with your antibody test?

It typically takes 10 minutes to find out if you have Covid19 through the rapid antibody test

12What kind of Covid tests are there?

Two types of tests are; Antibody and PCR. The Antibody test is typically a Serological Test and Instant Screening (10-minute result). The PCR test is the Gold Standard for Point of Care Diagnostic, however the sample analysis requires an expensive machine to determine the result.

13How can a business test their employees for Covid?

Businesses may test their employees through the surveillance model. “Serology surveillance is a strategy which includes using serology testing for surveillance of a group or organization to better understand how many infections with SARS-CoV-2 have occurred in a given population.”

14Is it legal to test my employees for Covid19?

Yes you can test your employees. Please recognize we are not authorized to offer legal advice.

15What kind of payment do you take?

Credit card is the preferred method of payment; wire transfer is available for larger purchases.

16How can I get Covid test kits for my school?

Call Medek Health by phone at (702) 612-4052.

17Where do I find Covid test kits for my school district?

Please submit your school information one the Test Kit Contact Request form, or give us a call at https://medekhealth.com/fda-authorized-covid19-igg-igm-rapid-antibody-test-kits/

18How long does it take to test my students for Covid 19?

10 minutes.

19How long does it take to perform a Covid test?

Our test kits will have results within 10 minutes.

20What do I do if an employee tests positive for Covid 19?

Sick employees should contact the CDC for recommendations and employers should consult with their local health department for guidance.

Medek Health is an authorized dealer of COVID-19 antibody test kits, bringing to your business, organization or government the most accurate COVID-19 antibody test kit at the most affordable rate available on the market.

COVID-19 Test Kit Direct Contact:

‪(888) 996-3335‬

FDA EUA authorized Covid19 test kits are now available - Tel: ‪(888) 996-3335‬

Our COVID-19 Antibody Test Kits

COVID-19 Test Kit Contact Request Form

PLEASE NOTE THIS IS NOT FOR INDIVIDUAL PURCHASE OR USE. THIS IS STRICTLY FOR BUSINESSES AND GOVERNMENTAL ORGANIZATIONS.

If you are an individual looking to be tested please visit our telemedicine providers

AVAILABLE

ACCURATE

AFFORDABLE

Let Medek be your testing partner

Medek Health is an authorized dealer of COVID-19 antibody test kits, bringing to your business, organization or government the most accurate COVID-19 antibody test kit at the most affordable rate available on the market.

COVID-19 Test Kit Direct Contact:

COVID-19 Test Kit Contact Request Form

COVID19 IGG / IGM Rapid Test Kit

Additional Resources

Additional Notices

General Information

Frequently Asked Questions

Medek Health is an authorized dealer of COVID-19 antibody test kits, bringing to your business, organization or government the most accurate COVID-19 antibody test kit at the most affordable rate available on the market.

COVID-19 Test Kit Direct Contact:

COVID-19 Test Kit Contact Request Form

Get Started

Ready to avoid the waiting room and expensive visits? It only
takes a few minutes to get started. Download now.

FDA EUA authorized Covid19 test kits are now available - Tel: ‪(888) 996-3335‬

Our COVID-19 Antibody Test Kits

COVID-19 Test Kit Contact Request Form

PLEASE NOTE THIS IS NOT FOR INDIVIDUAL PURCHASE OR USE. THIS IS STRICTLY FOR BUSINESSES AND GOVERNMENTAL ORGANIZATIONS.

If you are an individual looking to be tested please visit our telemedicine providers

AVAILABLE

ACCURATE

AFFORDABLE

Let Medek be your testing partner

Medek Health is an authorized dealer of COVID-19 antibody test kits, bringing to your business, organization or government the most accurate COVID-19 antibody test kit at the most affordable rate available on the market.

COVID-19 Test Kit Direct Contact:

COVID-19 Test Kit Contact Request Form

COVID19 IGG / IGM Rapid Test Kit​

Additional Resources

Additional Notices

General Information

Frequently Asked Questions

Medek Health is an authorized dealer of COVID-19 antibody test kits, bringing to your business, organization or government the most accurate COVID-19 antibody test kit at the most affordable rate available on the market.

COVID-19 Test Kit Direct Contact:

COVID-19 Test Kit Contact Request Form

Get Started

Ready to avoid the waiting room and expensive visits? It only takes a few minutes to get started. Download now.

COVID19 IGG / IGM Rapid Test Kit

Ready to avoid the waiting room and expensive visits? It only
takes a few minutes to get started. Download now.