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Poly stat
Flu A & B, Immunochromatographic
Details
Device typeInfluenza A/B virus neuraminidase activity IVD, kit, rapid ICT, clinical: A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of neuraminidase activity specific to influenza A virus and/or influenza B virus in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
FDA categoryAntigens, Cf (Including Cf Control), Influenza Virus A, B, C
Device ID00855574005407
Single useYes
MRI safetyLabeling does not contain MRI Safety Information