Status™ COVID-19/Flu A&B

• K Number: K251538
• Device Name: Status™ COVID-19/Flu A&B
• Manufacturer: Princeton BioMeditech Corp.
• Date Cleared: 2025-11-14 ( 179 days)
• Product Code: SCA
• Regulation Number: 866.3987
• Type: Dual Track
• Panel: Microbiology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

N/A