Covid-19 IgG/IgM Rapid Test
20 TESTS PER BOX
FREE SAME DAY SHIPPING
NPI NUMBER REQUIRED * PROFESSIONAL USE ONLY
EUA approval datedSeptember 23, 2020 Submission number EUA200487
|Product sold: 20 tests per box|
|$269.80 per box||$259.80 per box||$239.80 per box||$219.80 per box||199.80 per box||$179.80
|$139.80 per box|
|Bulk discounts will be applied automatically.|
FOR ADDITIONAL QUANTITIES OVER 20 BOXES PLEASE CONTACT US!
10998 in stock
Test has EUA approval dated September, 23. 2020 Submission number EUA200487 Covid-19 Testing
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
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 INSERT : 5-EUA200487 Assure IgG IgM IFU 07062020 FINAL
AUTHORIZATION: Use of this test with all authorized specimen types is limited to
laboratories certified under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet
requirements to perform moderate or high complexity tests.
This test is also authorized for use with fingerstick whole blood
specimens only at the Point of Care (POC), i.e., in patient care
settings operating under a CLIA Certificate of Waiver, Certificate
of Compliance, or Certificate of Accreditation.
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. Covid-19 Testing.
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.
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)
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.
Most people infected with the COVID-19 virus will experience mild to moderate respiratory illness and recover without requiring special treatment. Older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness.
The best way to prevent and slow down transmission is be well informed about the COVID-19 virus, the disease it causes and how it spreads. Protect yourself and others from infection by washing your hands or using an alcohol based rub frequently and not touching your face.
|Dimensions||7 × 5 × 3 in|