FDA-Device2021-03-17Class III
Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
OraSure Technologies, Inc.
Hazard
Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the specification sheet listed the Substrate Reagent (TMB) lot 6676239, but contained Substrate Reagent (TMB) lot 6679623, should not affect performance.
Sold states
US Nationwide distribution in the states of KS, NJ, OH, VA.
Affected count
16 units
Manufactured in
220 E 1st St, Bethlehem, PA, United States
Products
Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1183-2021Don't want to check this manually?
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