Osom Ultra Plus Flu A&B Test Kit
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K192719 FDA 510(k)
- FDA Product Code
- PSZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3328 FDA 510(k)
- Regulation Number
- 866.3328 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Osom Ultra Plus Flu A&B Test Kit is a rapid in vitro diagnostic device designed to detect influenza A and B nucleoprotein antigens directly from nasal or nasopharyngeal swab specimens. It functions as a qualitative test, providing results within 10 minutes to aid in the diagnosis of respiratory infections caused by these viruses.
This single-use test kit is intended for use in point-of-care settings, such as clinics, emergency departments, and physician offices. Supplied as a sterile, ready-to-use device, it requires no additional reagents beyond the provided swabs and buffer. The kit is CLIA-waived, allowing for testing in non-laboratory environments, and is manufactured in the USA. It includes two additional tests for quality control purposes without extra charge.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: OSOM® Ultra Plus Flu A&B Test - Sekisui Diagnostics, SEKISUI Diagnostics™ OSOM™ Ultra Plus Flu A and B Test Kit, OSOM® Ultra Plus Flu A&B Test - CLIA Waived, Made In USA, QC ... - Amazon, SEKISUI Diagnostics™ OSOM™ Ultra Flu A and B Rapid Test
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192719 | Class II | Active |
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Manufacturer
- Manufacturer
- Sekisui Diagnostics, LLC
Sources (1)
- FDA 510(k) K192719 24 fields · synced Sep 20, 2026