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LYR — Helicobacter Pylori Class I

FDA Device Classification

Classification Details

Product Code
LYR
Device Class
Class I
Regulation Number
866.3110
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K232892biomericaHp Detect™ Stool Antigen ELISADecember 15, 2023
K230901meridian biosciencePremier HpSA Flex (619096)July 3, 2023
K192817meridian bioscienceCurian HpSA, Curian AnalyzerMarch 13, 2020
K183573panion and bf biotechVstrip H. pylori Antigen Rapid TestMarch 14, 2019
K182559meridian biosciencePREMIER Platinum HpSA PLUSNovember 5, 2018
K181464diasorinLIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetAugust 31, 2018
K181379techlabH. PYLORI QUIK CHEKAugust 21, 2018
K181400techlabH. PYLORI CHEK™August 21, 2018
K161139diasorinLIAISON H. pylori IgG, LIAISON H. pylori IgG Control SetJuly 22, 2016
K153661meridian bioscienceImmunoCard STAT! HpSAMarch 14, 2016
K151935alere san diego, incorporatedAlere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori WholAugust 12, 2015
K141133biomerieuxVIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIJuly 9, 2015
K110745gold standard diagnosticsHELICOBACTER PYLORI ELISA IGG TEST KITMarch 2, 2012
K110899gold standard diagnosticsGOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KITFebruary 1, 2012
K052716otsuka pharmaceutical coRAPIRUN H. PYLORI ANTIBODY DETECTION KITNovember 16, 2006
K052708arj medicalPYLO-PLUSMay 1, 2006
K053335meridian biosciencePREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480March 10, 2006
K041238biohitHELICOBACTER PYLORI IGG ELISADecember 13, 2004
K032222meridian bioscienceIMMUNOCARDSTAT HPSADecember 5, 2003
K033067trinity biotech usaPYLORI IGGNovember 26, 2003