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510(k) K252283

Nano-Check Influenza A+B Test by Nano-Ditech Corporation — Product Code PSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2026
Date Received
July 22, 2025
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 Nano-Ditech Corporation

  • K243561 — Nano-Check Influenza+COVID-19 Dual Test (June 17, 2025)
  • K240280 — Nano-Check™ RSV Test (July 30, 2024)
  • K231187 — Nano-Check™ COVID-19 Antigen Test (January 23, 2024)
  • K102131 — NANO-CHECK AMI CTNI CARDIAC MARKER TEST (October 20, 2010)
  • K102441 — NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN (October 20, 2010)

Other clearances for product code PSZ

  • 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)
  • K192719 — Osom Ultra Plus Flu A&B Test Kit (April 3, 2020)
  • 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)