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510(k) Data Aggregation
K Number
K110761Device Name
MICT TSH
Manufacturer
Date Cleared
2012-03-09
(357 days)
Regulation Number
862.1690Why did this record match?
Applicant Name (Manufacturer) :
MAGNABIOSCIENCES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MICT® TSH is a magnetic lateral flow immunoassay for the in-vitro quantitative determination of TSH in human serum. The measurements of thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The MICT System is intended for use in clinical laboratories.
Device Description
The MICT® TSH Immunoassay for the quantitative determination of TSH in human serum is designed for use on MICT® Instrument.
MICT® TSH Device Reagents:
1. Solid phase nitrocellulose membrane device with two detection zones:
a. Control line region containing a polyclonal goat anti-rabbit IgG antibody, and
b. Test line region containing a monoclonal anti-TSH antibody
2. Lyophilized conjugate tube containing the monoclonal anti-TSH antibody covalently coupled to 300 nm super paramagnetic particles.
The MICT® Immunoassay is a "sandwich" magnetic chromatographic assay.
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