FDA-Device2013-12-25Class II
Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci
Remel Inc
Hazard
The product may give weak or false negative test results.
Sold states
Nationwide Distribution
Affected count
109 kits
Manufactured in
12076 Santa Fe Trail Dr, N/A, Lenexa, KS, United States
Products
Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0538-2014Don't want to check this manually?
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