Sentosa SX Sars-CoV-2 Reagent EUA 368/Box
1389755 Vela Diagnostics USA, Inc - 301068
Delivery by if you order within
Delivery by
Unit Of Measure
Price
Quantity
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 frozen and will be shipped separately. Frozen items do not ship on Friday unless prior arrangement are made for Saturday delivery.
Description
Sentosa SX Sars-CoV-2 Reagent EUA 368/Box
Features & Benefits:
- • 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 detection of nucleic acid from 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 diagnostics 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. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner
Product Attributes
Category
Molecular Testing
UNSPSC Taxonomy
41116100- MANUAL TEST KITS AND QUALITY CONTROLS AND CALIBRATORS AND STANDARDS
Additional Attributes
Return Policy
Specifications
Item
Reagent
Item Type
Sars-CoV-2
Brand
Sentosa SX
Additional Attributes
PCR Test (EUA)
CLIA Classification
EUA