Gentamicin 120 Ug, Streptomycin 30 Ug Sensi-disc Susceptibility Tests

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

Full name

Gentamicin 120 Ug, Streptomycin 30 Ug Sensi-Disc Suspectibility Tests

510(k) Number

K943407 ↗

FDA Product Code

JTN

Device Class

Class II

Regulation

21 CFR Part 866.1620

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Gcii Agar with Isovitalx(R) Enrichment

  Class II

  FDA 510(k) K945569 Active Cleared 2 Feb 1995

• Fosfomycin, 200 Mg, Sensi-Disc

  Class II

  FDA 510(k) K972098 Active Cleared 28 Jul 1997

• Meropenem, 10 Mcg, Sensi-Disc Open recall

  Class II

  FDA 510(k) K963845 Active Cleared 25 Oct 1996

• Enterococcus Screening Medium

  Class II

  FDA 510(k) K951539 Active Cleared 13 Jun 1995

• Sparflozacin, 5 Mcg, Sensi-Disc

  Class II

  FDA 510(k) K970385 Active Cleared 10 Mar 1997

• Crystal Enteric/Nonfermenter Id System

  Class I

  FDA 510(k) K926018 Active Cleared 11 Mar 1993

See all devices from Becton Dickinson Microbiology Systems →

• What antibiotics and concentrations are on this susceptibility test disc?

  The disc combines gentamicin at 120 µg and streptomycin at 30 µg. These fixed amounts allow the disc diffusion method to assess whether a microorganism is sensitive, intermediate, or resistant to each agent based on zone‑of‑inhibition measurements.

• Is the disc supplied sterile and intended for single use?

  Yes, the product is provided as a sterile, single‑use test disc. Sterility ensures no contaminating organisms affect the diffusion results, and single‑use eliminates cross‑contamination between specimens, which is essential for reliable susceptibility data.

• In what laboratory setting should this disc be used?

  The disc is designed for clinical microbiology laboratories that perform antimicrobial susceptibility testing. It is used with standard agar plates and the disc diffusion technique to evaluate the susceptibility of bacterial isolates to gentamicin and streptomycin.

• How is this device classified and what regulatory clearance does it have?

  It is classified as a Class II medical device and has received FDA 510(k) clearance (product code JTN, regulation 866.1620). The clearance indicates it is substantially equivalent to a legally marketed predicate device for the same intended use.