FDA-Device2014-01-22Class II
Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per cartridge. Firm name on the label is Oxoid, Ltd., Basingstoke, United Kingdom. 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
Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes.
Sold states
Nationwide Distribution including the states of AL, AZ, CA, CO, FL, HI, IA, IL, KY, LA, MD, MI, MN, MO, MS, NC, NY, OH, SC, TN, TX, VA, WI, and WV
Affected count
45/5/50 - discs/cartridges/packs
Manufactured in
12076 Santa Fe Trail Dr, Lenexa, KS, United States
Products
Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per cartridge. Firm name on the label is Oxoid, Ltd., Basingstoke, United Kingdom. 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-0734-2014Don't want to check this manually?
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