Etest Telavancin in 0.002-32 ug/mL and 0.016-256 ug/mL

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K102535 ↗

FDA Product Code

JWY

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• ETEST Delafloxacin (DFX) (0.002-32 µg/mL)

  Class II

  CE/IVDR FDA 510(k) K192738 Active Cleared 26 Nov 2019 +1authorizations

• ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)

  Class II

  CE/IVDR FDA 510(k) K250274 Active Cleared 30 Apr 2025

• ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)

  Class II

  CE/IVDR FDA 510(k) K183031 Active Cleared 11 Jan 2019

• Etest Ceftaroline (0.002 - 32ug/ml)

  Class II

  FDA 510(k) K151873 Active Cleared 7 Oct 2015

• ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)

  Class II

  CE/IVDR FDA 510(k) K190154 Active Cleared 1 May 2019

• Vidas C Difficile Gdh

  Class I

  FDA 510(k) K132010 Active Cleared 9 Oct 2013

See all devices from Biomerieux S.A. →

• What is the Etest Telavancin used for?

  The Etest Telavancin is a manual antimicrobial susceptibility test system used for determining the minimum inhibitory concentration (MIC) of telavancin against Gram positive aerobic microorganisms, helping clinicians guide and manage antibiotic therapy decisions.

• How is the Etest Telavancin supplied and what are its concentration ranges?

  The device is supplied as a single-use product for laboratory use in microbiology settings. It is available in two concentration ranges: 0.002-32 ug/mL and 0.016-256 ug/mL, providing flexibility in testing different microorganisms.

• Is the Etest Telavancin reusable and what are its storage requirements?

  The Etest Telavancin is a single-use product and should not be reused. It should be stored according to the manufacturer's instructions to maintain its integrity and accuracy. The device is not MRI safe.

• What is the regulatory status of the Etest Telavancin?

  The Etest Telavancin has received FDA 510(k) clearance with the product code JWY and is classified as a Class II medical device. It was determined to be substantially equivalent to predicate devices through the traditional clearance process.