
Alere Scarborough, Inc.
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BinaxNOW G6PD Test is an FDA 510(k)-cleared medical device (K161364) manufactured by Alere Scarborough, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 16, 2016. Regulation: 8.