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Sentosa SX 301068 Sars-CoV-2 Reagent
Laboratory / Molecular Testing / 1389755 | Vela Diagnostics USA Inc. - 301068
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Category: Laboratory
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Sentosa SX Sars-CoV-2 Reagent EUA 368/Bx
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Category:
Laboratory
/
Molecular Testing
UNSPSC:
41116100
Additional attributes
Sentosa SX Sars-CoV-2 Reagent EUA 368/Bx
1389755
| Vela Diagnostics USA Inc. - 301068
Description:
Sentosa SX Sars-CoV-2 Reagent EUA 368/Box
Category:
Laboratory
/
Molecular Testing
UNSPSC:
41116100
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Product Overview
Product feature summary
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
Specifications
Product specifications and dimensions
Additional Attributes
PCR Test (EUA)
Brand
Sentosa SX
CLIA Classification
EUA
Item
Reagent
Item Type
Sars-CoV-2
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