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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Clearblue Digital Preg and Visual Ovulation Test; Clearblue Digital Pregnancy Test; CVS Digital Early Pregnancy Test; CVS Yes/No Digital Pregnancy Test; Equaline Digital Pregnancy Test; HEB Digital Pregnancy Test; Rite Aid Digital Pregnancy Test; Shoppers Drug Mart Digital Early and Visual Pregnancy Test; Signature Care Digital Pregnancy Test; Target Digital Pregnancy Test; Topcare Digital Pregnancy Test; Walgreens Digital Early Pregnancy Test
Classification Name: KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
Product Code: LCX
Device Class: 2
Regulation Number: 862.1155
Medical Specialty: Clinical Chemistry
Registered Establishment Name: Abbott Diagnostics (Shanghai) Co., Ltd.
Registered Establishment Number: 3005128563
Premarket Submission Number: K060128
Owner/Operator: Abbott Rapid Diagnostics Inc
Owner/Operator Number: 9006731
Establishment Operations: Contract Manufacturer
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