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510(k) Data Aggregation
K Number
K050305Device Name
ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2
Manufacturer
Date Cleared
2005-05-23
(104 days)
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
BIOSCREEN MEDICAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
One Step hCG Pregnancy Urine Test device is a qualitative, two sites sandwich immunoassay test device designed for the determination of human chorionic gonadotropin (hCG) concentration in urine samples, and therefore is an aid in the early detection of pregnancy. These test devices available in strip, cassette and midstream formats are intended for overthe-counter (OTC) use. The test devices in cassette and strip format are for professional use as well. For in-vitro diagnostic use only.
One Step hCG Pregnancy Urine/Serum Test device is a qualitative, two sites sandwich immunoassay test device designed for the determination of human chorionic gonadotropin (hCG) concentration in urine and serum samples, and therefore is an aid in the early detection of pregnancy. These test devices available in strip and cassette formats are intended for professional use only. For in-vitro diagnostic use only.
Device Description
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