Copan Easy-Swab Collection and Transport System

• • Ongoing Z-1937-2025 FDA Class II ·initiated 2 May 2025

  Swabs for specimen collection may be prone to breakage during product usage.

510(k) Number

K993161 ↗

FDA Product Code

JTW

Device Class

Class I

Regulation

21 CFR Part 866.2900

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 Venturi Transystem Liquid Stuarts Medium Open recall

  Class I

  FDA 510(k) K946283 Active Cleared 10 Mar 1995

• 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. →