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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Clearblue +/- Ovulation and Digital Pregnancy; Clearblue +/- Ovulation Test; Clearblue Connected Ovulation Test System; Clearblue Preg Planning Kit; Walmart Equate Early Ovulation
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: K981271
Owner/Operator: Abbott Rapid Diagnostics Inc
Owner/Operator Number: 9006731
Establishment Operations: Contract Manufacturer
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