ClearanceBrief
Panels › Immunology › Product code MST · Class 2

Antibodies, Gliadin

Regulation 866.5750

0510(k)s in 12 months (42 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
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Top companies in MST

Company510(k)sRecalls
Inova Diagnostics, Inc.80
Immco Diagnostics, Inc.40
Phadia US, Inc.22
Zeus Scientific, Inc.40
The Binding Site, Ltd.30
Diamedix Corp.21
Aesku Diagnostics20
Cogent Diagnotics , Ltd.20
Euroimmun Us, Inc.20
Micro Detect, Inc.20
DateFirm and productCodeLinked 510(k)
Jun 30, 2023Phadia US Inc
Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac di
Open, Classified		 MSTK093459
Jun 30, 2023Phadia US Inc
EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin i
Open, Classified		 MSTK093459
Sep 16, 2008Diamedix Corporation
Is-anti-Gliadin IgG Enzyme Immunoassay Test Kit packaged in cardboard boxes with individual components secured within a foam insert. Catalog Number # 720-800. - Laboratory In-Vitro Diagnostic Assay in
Terminated		 MSTK012795

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