FDA-Device2014-04-30Class II
Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England.
Remel Inc
Hazard
A reagent contained within the product may return false negative results.
Sold states
Distribution was made to CA, FL, IL, MA, ME, NJ, PA, TN, TX, VA, and VT. There was no foreign/military/government distribution.
Affected count
72/50-test boxes
Manufactured in
12076 Santa Fe Trail Dr, N/A, Lenexa, KS, United States
Products
Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1473-2014Don't want to check this manually?
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