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Found 1 results

510(k) Data Aggregation

K Number

Device Name

GenaCheck COVID-19 Rapid Self-Test

Manufacturer

Genabio Diagnostics Inc

Date Cleared

2025-09-05

(88 days)

Product Code

Regulation Number

Type

Panel

Microbiology (MI)

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N/A

Why did this record match?

Device Name :

GenaCheck COVID-19 Rapid Self-Test

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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