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Panels › Microbiology › Product code LYR · Class 1

Helicobacter Pylori

Regulation 866.3110

0510(k)s in 12 months (91 all time)

2recalls in 12 months (11 all time)

5recalls that name a 510(k)

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Top companies in LYR

Company	510(k)s	Recalls
Meridian Bioscience, Inc.	6	1
Quidel Corp.	6	0
BIOMERIEUX	2	3
Meridian Diagnostics, Inc.	5	0
Biomerica, Inc.	3	0
Calbiotech Inc	0	2
Chemtrak, Inc.	2	0
Diagnostic Products Corp.	1	1
DiaSorin, Inc.	2	0
E-Z-Em, Inc.	2	0

Date	Firm and product	Code	Linked 510(k)
Dec 1, 2025	GET TESTED INTERNATIONAL AB Peptic Ulcer Test (H, pylori) Open, Classified	LYR	None listed
Dec 1, 2025	GET TESTED INTERNATIONAL AB H pylori (Peptic ulcer) Test Open, Classified	LYR	None listed
Jan 10, 2024	Immunostics, Inc. Detector H. Pylori, Catalog Number IHP-30 Open, Classified	LYR	K980798
Jan 4, 2023	Biomerieux Inc VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01 Open, Classified	LYR	K141133
Jan 4, 2023	Biomerieux Inc VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702 Open, Classified	LYR	None listed
Jan 4, 2023	Biomerieux Inc VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226 Open, Classified	LYR	K141133
Mar 11, 2011	BioCheck Inc H pylori IgG ELISA kit (Qualitative) H pylori IgG ELISA kit (Quantitive) H pylori IgG ELISA kit BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum. Terminated	LYR	None listed
Mar 5, 2010	Calbiotech Inc H. Pylori IgM ELISA 96 Well Kit, Catalog Number: HP015M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. Terminated	LYR	None listed
Mar 5, 2010	Calbiotech Inc H. Pylori IgA ELISA 96 Well Kit, Catalog Number: HP014A The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. Terminated	LYR	None listed
Sep 11, 2003	Diagnostic Products Corp Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test size kit) Terminated	LYR	K000463
Jan 23, 2003	Meridian Bioscience Inc Premier Platinum brand HpSA, diagnostic test kits, one kit per pouch, one pouch per shipping box. Terminated	LYR	K983255

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