Poly stat MN20

• FDA 510(k) K961024 decided 4 Feb 1997 Active
• FDA GUDID UDI-DI 00816917021546 listed 23 Sep 2016 Listed

1. 4 Feb 1997 Cleared FDA 510(k) K961024
2. 23 Sep 2016 Listed FDA GUDID 00816917021546

Trade name

Poly stat

Generic name

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical

Model / reference

MN20

Primary DI / UDI-DI

00816917021546

510(k) Number

K961024 ↗

FDA product code

KTN

GMDN term

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical

Device class

Class II

Regulation number

866.5640

GUDID distribution status

In Commercial Distribution

Category: Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical

Other devices filed under FDA product code KTN (System, Test, Infectious Mononucleosis).

• MONO-PHILE by Bio Diagnostic Systems, Inc.
• CARDS O.S. MONO by Pacific Biotech, Inc.
• BIOSIGN MONO-PLUS WB, BIOSIGN MONO WB, MONO-PLUS WB, ACCUSIGN MONO WB by PRINCETON BIOMEDITECH CORP.
• EYE SPOT IM TEST by J.S. Medical Assoc.
• MONOSTAR SYSTEM: IM LATEX TEST by U.S. Health Resources Corp.
• OXOID INFECTIOUS MONONUCLEOSIS KIT by Unipath, Ltd.
• GENZYME DIAGNOSTICS CONTRAST MONO by Genzyme Diagnostics
• DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST by Quidel Corp.
• DRYSPOT INFECTIOUS MONONUCLEOSIS KIT by Oxoid Ltd
• IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST by Ampcor, 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. →