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510(k) K250398

Innovita Flu A/B Antigen Rapid Test by Innovita (Tangshan) Biological Technology Co., Ltd. — Product Code PSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2025
Date Received
February 12, 2025
Clearance Type
Traditional
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.

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