FDA-Device2015-12-23Class II
Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.
Remel Inc
Hazard
Antibiotic concentration may be insufficient which may result in incorrect test results.
Sold states
Nationwide Distribution including IL, GA, FL, NC, CA, AL, MA, IN, MO, NY, TX, VA, KS, and IA. Product was also distributed to Puerto Rico.
Affected count
58/5/50 discs/catridges/packs
Manufactured in
12076 Santa Fe Trail Dr, N/A, Lenexa, KS, United States
Products
Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0443-2016Don't want to check this manually?
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