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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Best Choice +/- Preg Test; Best Choice Early Preg Test; CVS Visual Early Preg Test; Discount Drug +/- Preg Test; Equaline Visual Early Preg Test; Exchange Select +/- Preg Test; Fact Plus +/- Preg Test; Generic +/- Preg Test; Good Sense +/- Preg Test; Good Sense Visual Early Preg Test; Health Mart +/- Preg Test; HEB Bi-Ling Early Preg Test; Hy-Vee Visual Early Preg Test; Kroger +/- Preg Test; Loblaws +/- Preg Test; Loblaws Visual Early Preg Test; London Drug +/- Preg Test; Meijer +/- Preg Test; Meijer Visual Early Preg test; Pharmasave +/- Preg Test; Rite Aid +/- Preg Test; Rite Aid Early Pregnancy Bilingual Test; SDM +/- Preg Test; Shopko +/- Preg Test; Shopko Visual Early Preg Test; Shur Fine +/- Preg Test; Sunmark +/- Preg Test; Target +/- Preg Test; Target Visual Early Preg Test; Topcare Visual Early Preg Test; Walgreens Early Pregnancy Bilingual Test; Walgreens Visual Early Preg Test; Walmart Equate +/- Preg Test; Walmart Equate Visual Early Preg Test; Western Family +/- Preg Test; Western Family Visual Early Preg 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: K042280
Owner/Operator: Abbott Rapid Diagnostics Inc
Owner/Operator Number: 9006731
Establishment Operations: Contract Manufacturer
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