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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Accuclear +/- Preg Test; Best Choice +/- Preg Test; Best Choice Early Preg Test; Care One +/- Preg Test; CVS Visual Early Preg Test; CVS +/- Preg Test; CVS Early Bi-Ling Preg Test; CVS Health Advanced One Step Pregnancy Test; Discount Drug +/- Preg Test; Discount Drug Visual Early Preg Test; Dollar General +/- Preg Test; Equaline +/- Preg Test; Equaline Visual Early Preg Test; Exchange Select +/- Preg Test; Exchange Select Visual Early Preg Test; Fact Plus +/- Preg Test; Familiprix +/- Preg Test; Familiprix Visual Early Preg Test; Family Dollar Visual Early Preg Test; Generic +/- Preg Test; Good Neighbor +/- Preg Test; Good Neighbor Visual Early Preg Test; Good Sense +/- Preg Test; Good Sense Visual Early Preg Test; Health Mart +/- Preg Test; Health Mart Visual Early Preg Test; Healthy Accents +/- Pregnancy Test; HEB +/- Preg Test; HEB Bi-Ling Early Preg Test; HEB Visual Early Preg Test; Hy-Vee +/- Preg Test; Hy-Vee Visual Early Preg Test; Kmart Image Essentials +/- Preg Test; Kmart Smart Sense Visual Early Preg Test; Kroger +/- Preg Test; Kroger Visual Early Preg Test; Leader +/- Preg Test; Leader Visual Early Preg Test; Loblaws +/- Preg Test; Loblaws Visual Early Preg Test; London Drug +/- Preg Test; Meijer +/- Preg Test; Meijer Visual Early Preg test; Metro Early Preg Test; Pharmasave +/- Preg Test; Pharmasave Visual Early Preg Test; Preferred Plus +/- Preg Test; Preferred Plus One Step Preg Test; Preferred Plus Visual Early Preg Test; Premier Value +/- Preg Test; Premier Value Visual Early Preg Test; Price Chopper Visual Early Preg Test; Publix +/- Preg Test; Quality Choice +/- Preg Test; Quality Choice Visual Early Preg Test; Rite Aid +/- Preg Test; Rite Aid Early Pregnancy Bilingual Test; SDM +/- Preg Test; SDM Visual Early Preg Test; Select Brand +/- Preg Test; Shop Rite +/- Preg Test; Shop Rite Visual Early Preg Test; Shopko +/- Preg Test; Shopko Early Pregnancy Bilingual Test; Shopko Visual Early Preg Test; Shur Fine +/- Preg Test; Signature Care Visual Early Preg Test; Sunmark +/- Preg Test; Sunmark Visual Early Preg Test; Target +/- Preg Test; Target Visual Early Preg Test; Topcare +/- Pregnancy Test; Topcare Visual Early Preg Test; Walgreens +/- Preg Test; Walgreens Early Pregnancy Bilingual Test; Walgreens Visual Early Preg Test; Walmart Equate +/- Preg Test; Walmart Equate Visual Early Preg Test; Walmart Visual Early Preg Test; Western Family +/- Preg Test; Western Family Visual Early Preg Test; Winco Foods +/- Preg Test; Winco Foods 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: INVERNESS MEDICAL, LLC.
Registered Establishment Number: 3012402291
Premarket Submission Number: K042280
Owner/Operator: Abbott
Owner/Operator Number: 9006731
Establishment Operations: Repackager/Relabeler
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