AscencioDx Molecular Detector CLIA Exempt Ea
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 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 product is shipped directly from the manufacturer and may incur additional fees and/or freight charge from the manufacturer. Item is non-returnable.
This product is currently authorized for EUA use and is restricted for sale. Please contact your Henry Schein Sales Consultant for additional information.
This item requires a CLIA License to purchase this product.
This item is non-returnable.
This product is no longer available. Please see our suggested substitute, search catalog for alternative item, or contact your sales consultant for assistance.
This product is no longer available. It is maintained in Aruba so that customers with purchase history can see the descriptions. Pleasesearch for a substitute.
This product is no longer available. It is maintained in the catalog so that customers with purchase history can see the descriptions. Please search for a substitute.
This product is no longer available. It is maintained in the catalog so that customers with purchase history can see the descriptions. Please search for a substitute.
This product is no longer available. Please see our suggested substitute, search catalog for alternative item, or contact your sales consultant for assistance.
Description
- • This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories.
- • This test is authorized for the qualitative detection of nucleic acid from SARS-CoV-2 in direct anterior nasal swab specimens from individuals suspected of COVID-19 by their healthcare provider.
- • This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
- • Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate, or waived complexity tests. This test is authorized for use 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 Acc
Product Attributes
Return Policy
Specifications
Item
Detector
Item Type
Molecular
Brand
AscencioDx
CLIA Classification
CLIA Exempt