FDA-Device2015-08-19Class II
PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of beta-hemolytic streptococci of Lancefield Groups A, B, C, F or G from primary culture plates.
Remel Inc
Hazard
A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
Sold states
Nationwide Distribution, including Puerto Rico and the country of Canada.
Affected count
1859 kits
Manufactured in
12076 Santa Fe Trail Dr, N/A, Lenexa, KS, United States
Products
PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of beta-hemolytic streptococci of Lancefield Groups A, B, C, F or G from primary culture plates.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2350-2015Don't want to check this manually?
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