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510(k) Data Aggregation
K Number
K062703Device Name
ONE STEP HCG PREGNANCY TEST
Manufacturer
Date Cleared
2007-07-23
(315 days)
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
AI DE DIAGNOSTIC CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
One Step HCG Urine Pregnancy Test is a rapid device, two sites sandwich immunoassay test device designed for the qualitative determination of human chorionic gonadotropin (hCG) concentration in human urine samples, and therefore is an aid in the early detection of pregnancy. These test devices are available in the formats of strip, cassette and midstream. The midstream format is intended for OTC use. The cassette and strip format are intended for both over-the counter (OTC) use and use in clinical laboratories.
One Step HCG Serum/Urine Combo Pregnancy Test is a rapid device, two sites sandwich immunoassay test device designed for the qualitative determination of human chorionic gonadotropin (hCG) concentration in human urine or serum samples, and therefore is an aid in the early detection of pregnancy. These test devices are available in strip format and cassette format, and are intended for in vitro diagnostic professional use in clinical laboratories only.
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