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510(k) Data Aggregation
K Number
K981243Device Name
BIOSTRIDE FREE T4 EIA TEST KIT
Manufacturer
Date Cleared
1998-06-29
(84 days)
Product Code
Regulation Number
862.1695Why did this record match?
Applicant Name (Manufacturer) :
BIOSTRIDE DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This Enzyme immunoassay is used for the quantitative estimation of non-protein bound thyroxine(Free T4) in human serum. This is an in vitro diagnostic device used to assist in the assessment of thyroid function.
Device Description
The Biostride Free T4 EIA Test Kit is an in vitro enzyme immunoassay for the quantitative estimation of freeT4, thyroxine, in human serum. This Free T4 test is a colorimetric microtiter plate enzyme immunoassay (EIA).
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