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)
Top companies in MST
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 30, 2023 | Phadia 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 |
MST | K093459 |
| Jun 30, 2023 | Phadia 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 |
MST | K093459 |
| Sep 16, 2008 | Diamedix 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 |
MST | K012795 |
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