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Covid-19 IgG/IgM Rapid Test

$699.00 $599.00

$499ea w/ PURCHASE OF 2 BOXES
COVID-19 (20) TESTS PER BOX
FREE SHIPPING ON ALL ORDERS
SAME DAY SHIPPING
EUA AUTHORIZED

NPI NUMBER REQUIRED * PROFESSIONAL USE ONLY
EUA approval dated July 6. 2020 Submission number EUA200487

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Product sold: 20 tests in 1 case
2-4
BOXES
5-9
BOXES
10-19
BOXES
20+
BOXES
$499 per box $399 per box $349 per box $324 per box
$24.95 per test $19.95 per test $17.45 per test $16.20 per test
Bulk discounts will be applied automatically.

ADDITIONAL QUANTITIES 40 CASES+ $299 per box

7676 in stock

Quantity Price
1 $599.00
2 - 4 $499.00
5 - 9 $399.00
10 - 19 $349.00
20 - 39 $324.00
40+ $299.00

Test has EUA approval dated July 6. 2020 Submission number EUA200487

COVID-19 IgG/IgM - Rapid Test Kit

What is Coronavirus?
Coronaviruses are a kind of infection. There are a wide range of varities. A recently perceived coronavirus,
SARS-CoV-2, has caused an overall pandemic of respiratory sickness, called COVID-19.

Coronavirus Symptoms include: Cough. Fever. Brevity of breath. Muscle hurts. Sore throat. Unexplained loss of taste or smell. Diarrhea. Migraine.

Seven human coronaviruses (HCoVs) have been so far recognized, prominently HCoV-229E, HCoV-OC43, HCoV-NL63, HCoV-HKU1, genuine intense respiratory disorder coronavirus (SARS-CoV), Middle East respiratory condition coronavirus (MERS-CoV) and the novel coronavirus (2019-nCoV, a.k.a. SARS-CoV-2).

In agreement to the profoundly pathogenic SARS-CoV, MERS-CoV, and 2019-nCoV, the four purported basic HCoVs for the most part cause moderate upper-respiratory tract sickness and add to 15%–30% of instances of regular colds in human grown-ups. Extreme and dangerous lower respiratory tract diseases can in some cases happen in the old, newborn children and additionally immunocompromised patients.

What Does the COVID-19 IgG/IgM Rapid Test Device Detect?

The COVID-19 IgG/IgM Rapid Test Device is an in vitro immunoassay for the immediate and subjective location of hostile to
SARS-CoV-s IgM and against SARS-CoV-2 IgG in human entire blood, serum or plasma as a guide in the finding of essential and second SARS-COV-2 diseases.

THIS TEST IS FOR PROFESSIONAL USE ONLY
EUA AUTHORIZED
CONFIRMATION OF NPI# AND MEDICAL USE WILL BE REQUIRED AT TIME OF PURCHASE

AUTHORIZATION LETTER: EUA200487 Assure Letter of Authorization_07062020 FINAL
FOR HEALTHCARE PROVIDERS: 3-EUA200487 Assure HCP FS 07062020 FINAL
FOR RECIPIENTS: 4-EUA200487 Assure Recipient FS 07062020 FINAL
PACKAGE INSERT5-EUA200487 Assure IgG IgM IFU 07062020 FINAL

Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments
of 1988 (CLIA), 42 U.S.C. 263a, which meets requirements to perform moderate or high complexity tests.

AUTHORIZATIONS:
04/09/2020: Lab Update: FDA Clarifies CLIA-waived Status for Point-of-Care SARS-CoV-2 Tests under Emergency Use Authorizations

Audience: Clinical Laboratory Professionals

Level: Laboratory Update

FDA Clarifies CLIA-waived Status for Point-of-Care SARS-CoV-2 Tests under Emergency Use Authorizations

The U.S. Food and Drug Administration (FDA) recently clarified that, when it grants an Emergency Use Authorization (EUA) for a point-of-care test, that test is deemed to be CLIA-waived. For the duration of the national emergency declaration for COVID-19, such tests can be performed in any patient care setting that operates under a CLIA Certificate of Waiver or Certificate of Compliance/Certificate of Accreditation.

In addition, FDA clarified that tests for SARS-CoV-2 that are offered prior to or without a EUA have not been reviewed by FDA, are not FDA authorized, and have not received a CLIA categorization external icon. Thus, those tests are considered high complexity by default until they receive a EUA or other FDA approval that indicates they may be performed as moderate complexity or waived tests.

For more information, visit this FDA Web page external icon, navigate to the section titled “General FAQs,” and view the first two questions and their corresponding answers.

Additional Resources:

Clinical Laboratory Improvement Amendments (CLIA)
Clinical Laboratory COVID-19 Response Weekly Calls
CDC COVID-19 Information for Laboratories
CDC COVID-19 Website
Register for CDC Health Alert Network (HAN) notifications, including updates about COVID-19. Enter your email address to sign up.
Laboratory Outreach Communication System | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)

www.cdc.gov/csels/dls/locs

DISCLAIMER:

HEALTH CARE PROFESSIONALS ARE RESPONSIBLE TO MEET ALL GOVERNMENT GUIDELINES, REGULATIONS, AND RULES TO MEET EMERGENCY USE AUTHORISED REGULATIONS, CLIA WAIVED AND ALL REPORTING REQUIREMENTS.

Additional information

Weight 0.2 lbs
Dimensions 7 × 5 × 3 in
0

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