Bion HSV1-G or HSV2-G Test System

• • Terminated Z-1477-2013 FDA Class III ·initiated 23 Jan 2013

  Affected products have a labeled expiration date of one year too long.

510(k) Number

K881261 ↗

FDA Product Code

GQO

Device Class

Class II

Regulation

21 CFR Part 866.3305

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Bion Borrelia Burgdorferi Antigen Substrate Slide

  Class II

  FDA 510(k) K901054 Active Cleared 5 Apr 1990

• Respiratory Syncytial Virus

  Class I

  FDA 510(k) K894623 Active Cleared 16 Oct 1989

• Bion Mumps-G Antibody Test System

  Class II

  FDA 510(k) K926066 Active Cleared 15 Jun 1993

• Bion Direct Identification Control Slide

  Class I

  FDA 510(k) K890616 Active Cleared 17 Feb 1989

• Mumps Virus

  Class I

  FDA 510(k) K894624 Active Cleared 16 Oct 1989

• Epstein-Barr Virus-Nuclear Antigen

  Class I

  FDA 510(k) K894626 Active Cleared 16 Oct 1989

See all devices from Bion Ent., Ltd. →