Biotime Sars-CoV-2 IgG/IgM Rapid Qualitative Test Moderately Complex 25/Box
Price
This item can only be sold to licensed practitioner or any other person(s) or entity licensed by the State.
This item is a professional use item. If your State License number is on file, we can ship this item to you. Otherwise, please include your State License number in the comments section of the order.
This product is a non stock item that must be ordered from the manufacturer, and as such, will appear on a separate order & will follow at a later date. Item is non-returnable.
This product is a refrigerated product and will be shipped separately. Refrigerated items do not ship on Friday unless prior arrangements are made for Saturday delivery.
This product has an Emergency Use Authorization (EUA) from the FDA. See attached documents: Emergency Use Authorization Letter, Instruction for Use, Healthcare Provider and Patient Fact Sheets.
Please note this item may ship standard ground delivery service. If you need priority delivery on this item, please remove the item from the cart and call 800-372-4346 to speak with a sales representative who can assist in having this item expedited from the manufacturer if possible.
This is a non-returnable item.
This item requires a CLIA License to purchase this product.
Description
- • This Test Has Not Been FDA Cleared Or Approved.
- • This Test Has Been Authorized By FDA Under An EUA.
- • This Test Has Been Authorized By FDA Under An EUA For Use By Laboratories Certified Under Clinical Laboratory Improvement Amendments Of 1988 (CLIA), 42 U.S.C 263a, That Meet Requirements To Perform Moderate Or High Complexity Tests.
- • This Test Has Been Authorized Only For The Presence Of IgM And IgG Antibodies Against SARSCoV-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 Diagnostic Tests For Detection And/or Diagnosis Of COVID-19 Under Section 564(b)(1) Of The Federal Food, Drug And Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), Unless The Authorization Is Terminated Or Revoked Sooner.
Product Attributes
Return Policy
Specifications
Item
Rapid Qualitative Test
Item Type
Sars-CoV-2 IgG/IgM
Brand
Biotime
CLIA Classification
Moderately Complex