Poly stat FLU22

• FDA 510(k) K132465 decided 9 Sep 2013 Active
• FDA GUDID UDI-DI 00855574005407 listed 23 Sep 2016 Listed

1. 9 Sep 2013 Cleared FDA 510(k) K132465
2. 23 Sep 2016 Listed FDA GUDID 00855574005407

Trade name

Poly stat

Generic name

Influenza A/B virus neuraminidase activity IVD, kit, rapid ICT, clinical

Model / reference

FLU22

Primary DI / UDI-DI

00855574005407

510(k) Number

K132465 ↗

FDA product code

GNX

GMDN term

Influenza A/B virus neuraminidase activity IVD, kit, rapid ICT, clinical

Device class

Class I

Regulation number

866.3330

GUDID distribution status

In Commercial Distribution

Category: Influenza A/B virus neuraminidase activity IVD, kit, rapid ICT, clinical

Other devices filed under FDA product code GNX (Antigens, Cf (Including Cf Control), Influenza Virus A, B, C).

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• SOFIA INFLUENZA A+B FIA by Quidel Corp.
• IMAGEN Influenza Virus A and B K610511-2 by OXOID LIMITED
• VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES by Zymetx, Inc.
• Remel R246003 by REMEL, INC.
• BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY by Baxter Healthcare Corp
• ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A by Microscan Div. Baxter Healthcare Corp.
• Status Flu A+B card BSP-510-25-02 by PRINCETON BIOMEDITECH CORP.
• REMEL XPECT FLU A&B by REMEL, INC.
• IMAGEN INFLUENZA VIRUS A AND B TESTMI by Boots-Celltech Diagnostics, Inc.

• C-Reactive Protein (Crp) Agglutination Latex Kit

  Class II

  FDA 510(k) K962049 Active Cleared 18 Dec 1996

• Poly stat STS25

  Class I

  FDA 510(k) K040708 Active Cleared 22 Nov 2004 GUDID on market

• Poly stat HCG-POC

  Class I

  FDA 510(k) K921206 Active Cleared 29 Apr 1992 GUDID on market

• Poly stat FLU25

  Class I

  FDA 510(k) K132465 Active Cleared 9 Sep 2013 GUDID on market

See all devices from Polymedco, Inc. →