K241652

Substantially Equivalent

DASH® SARS-CoV-2 & Flu A/B Test

Applicant: Nuclein, LLC
Product code: QOF
Advisory panel: Microbiology
Date received: 2024-06-07
Decision date: 2024-12-20
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Austin, TX, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.