Copan Venturi Transystem Liquid Stuarts Medium

• • Ongoing Z-2584-2024 FDA Class II ·initiated 20 Jun 2024

  Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing false positive results for other specimens, and/or delay to test results.

510(k) Number

K946283 ↗

FDA Product Code

JSM

Device Class

Class I

Regulation

21 CFR Part 866.2390

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Copan Viral Transystem

  Class I

  FDA 510(k) K001780 Active Cleared 31 Jul 2001

• Copan Venturi Transystem Liquid Amies Medium

  Class I

  FDA 510(k) K946288 Active Cleared 10 Mar 1995

• Copan Easy-Swab Collection and Transport System Open recall

  Class I

  FDA 510(k) K993161 Active Cleared 9 Nov 1999

• Copan Venturi Transystem Stuarts Medium

  Class I

  FDA 510(k) K946285 Active Cleared 10 Mar 1995

• Copan Venturi Transystem Amies Medium with Charcoal

  Class I

  FDA 510(k) K946284 Active Cleared 10 Mar 1995

• Copan Universal Transport Medium (Utm-Rt) System

  Class I

  FDA 510(k) K042970 Active Cleared 7 Dec 2004

See all devices from Copan Diagnostics, Inc. →