FDA-Device2014-01-29Class II

Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. 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

Cartridges may contain individual discs which were not impregnated with antibiotic.

Sold states
Nationwide Distribution: US including Puerto Rico.
Affected count
30 packs
Manufactured in
12076 Santa Fe Trail Dr, Lenexa, KS, United States
Products
Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. 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-0795-2014

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