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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: CVS Visual Ovulation Test; Exchange Select Visual Ovulation Test; Good Neighbor Visual Ovulation Test; HEB Visual Ovulation Test; Kroger Visual Ovulation Test; Leader Visual Ovulation Test; Rite Aid Visual Ovulation Test; SDM Visual Ovulation Test; Target Visual Ovulation Test; Topcare Visual Ovulation Test; Walgreens Visual Ovulation Test
Classification Name: RADIOIMMUNOASSAY, LUTEINIZING HORMONE
Product Code: CEP
Device Class: 1
Regulation Number: 862.1485
Medical Specialty: Clinical Chemistry
Registered Establishment Name: Abbott Diagnostics (Shanghai) Co., Ltd.
Registered Establishment Number: 3005128563
Premarket Submission Number: K002867
Owner/Operator: Abbott Rapid Diagnostics Inc
Owner/Operator Number: 9006731
Establishment Operations: Contract Manufacturer
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