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Nantong Biotechnology Co., Ltd.
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EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II) is an FDA 510(k)-cleared medical device (K123050) manufactured by Nantong Biotechnology Co., Ltd.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 4, 2013. Regulation: 8.