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510(k) K192719

Osom Ultra Plus Flu A&B Test Kit by SEKISUI Diagnostics, LLC — Product Code PSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2020
Date Received
September 26, 2019
Clearance Type
Dual Track
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Devices Detecting Influenza A, B, And C Virus Antigens
Device Class
Class II
Regulation Number
866.3328
Review Panel
MI
Submission Type

An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.

Other clearances by SEKISUI Diagnostics, LLC

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  • K182001 — Acucy Influenza A&B Test with the Acucy System (December 17, 2018)
  • K181436 — OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health M (June 22, 2018)
  • K121397 — OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 (December 28, 2012)
  • K123182 — OSOM INFLUENZA A&B TEST MODEL 190 (November 5, 2012)

Other clearances for product code PSZ

  • K252283 — Nano-Check Influenza A+B Test (January 15, 2026)
  • K250398 — Innovita Flu A/B Antigen Rapid Test (July 3, 2025)
  • K241188 — Acucy® Influenza A&B Test with the Acucy® 2 System (April 18, 2025)
  • K232434 — BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit (December 5, 2023)
  • K223016 — BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit (January 27, 2023)
  • K191514 — CareStart Flu A&B Plus (February 18, 2020)
  • K182001 — Acucy Influenza A&B Test with the Acucy System (December 17, 2018)
  • K182157 — BioSign Flu A+B (September 18, 2018)
  • K181853 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader (August 8, 2018)
  • K180438 — BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit (March 20, 2018)