LYR — Helicobacter Pylori

Class 1

Medical Specialty

Review Panel

Submission Type

FDA Authorisations (91)

Device Name	Manufacturer	K-Number	Decision Date
Hp Detect™ Stool Antigen ELISA	Biomerica, Inc.	K232892	2023-12-15
Premier HpSA Flex (619096)	Meridian Bioscience, Inc.	K230901	2023-07-03
Curian HpSA, Curian Analyzer	Meridian Bioscience, Inc.	K192817	2020-03-13
Vstrip H. pylori Antigen Rapid Test	Panion & BF Biotech, Inc.	K183573	2019-03-14
PREMIER Platinum HpSA PLUS	Meridian Bioscience, Inc.	K182559	2018-11-05
LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set	DiaSorin, Inc.	K181464	2018-08-31
H. PYLORI QUIK CHEK	Techlab, Inc.	K181379	2018-08-21
H. PYLORI CHEK™	Techlab, Inc.	K181400	2018-08-21
LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set	DiaSorin, Inc.	K161139	2016-07-22
ImmunoCard STAT! HpSA	Meridian Bioscience, Inc.	K153661	2016-03-14
Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only	Alere San Diego, Incorporated	K151935	2015-08-12
VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II	BIOMERIEUX	K141133	2015-07-09
HELICOBACTER PYLORI ELISA IGG TEST KIT	Gold Standard Diagnostics	K110745	2012-03-02
GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT	Gold Standard Diagnostics	K110899	2012-02-01
RAPIRUN H. PYLORI ANTIBODY DETECTION KIT	Otsuka Pharmaceutical Co., Ltd.	K052716	2006-11-16
PYLO-PLUS	Arj Medical, Inc.	K052708	2006-05-01
PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480	Meridian Bioscience, Inc.	K053335	2006-03-10
HELICOBACTER PYLORI IGG ELISA	Biohit Plc	K041238	2004-12-13
IMMUNOCARDSTAT HPSA	Meridian Bioscience, Inc.	K032222	2003-12-05
PYLORI IGG	Trinity Biotech USA	K033067	2003-11-26

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