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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

Company510(k)sRecalls
Meridian Bioscience, Inc.61
Quidel Corp.60
BIOMERIEUX23
Meridian Diagnostics, Inc.50
Biomerica, Inc.30
Calbiotech Inc02
Chemtrak, Inc.20
Diagnostic Products Corp.11
DiaSorin, Inc.20
E-Z-Em, Inc.20
Decided510(k)Device and applicantCode
Dec 15, 2023K232892Hp Detect™ Stool Antigen ELISA
Biomerica, Inc.
LYR
Jul 3, 2023K230901Premier HpSA Flex (619096)
Meridian Bioscience, Inc.
LYR
Mar 13, 2020K192817Curian HpSA, Curian Analyzer
Meridian Bioscience, Inc.
LYR
Mar 14, 2019K183573Vstrip H. pylori Antigen Rapid Test
Panion & BF Biotech, Inc., TW
LYR
Nov 5, 2018K182559PREMIER Platinum HpSA PLUS
Meridian Bioscience, Inc.
LYR
Aug 31, 2018K181464LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
DiaSorin, Inc.
LYR
Aug 21, 2018K181400H. PYLORI CHEK™
Techlab, Inc.
LYR
Aug 21, 2018K181379H. PYLORI QUIK CHEK
Techlab, Inc.
LYR
Jul 22, 2016K161139LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set
DiaSorin, Inc.
LYR
Mar 14, 2016K153661ImmunoCard STAT! HpSA
Meridian Bioscience, Inc.
LYR
Aug 12, 2015K151935Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori W
Alere San Diego, Incorporated
LYR
Jul 9, 2015K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS
BIOMERIEUX
LYR
Mar 2, 2012K110745HELICOBACTER PYLORI ELISA IGG TEST KIT
Gold Standard Diagnostics
LYR
Feb 1, 2012K110899GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT
Gold Standard Diagnostics
LYR
Nov 16, 2006K052716RAPIRUN H. PYLORI ANTIBODY DETECTION KIT
Otsuka Pharmaceutical Co., Ltd.
LYR
May 1, 2006K052708PYLO-PLUS
Arj Medical, Inc.
LYR
Mar 10, 2006K053335PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480
Meridian Bioscience, Inc.
LYR
Dec 13, 2004K041238HELICOBACTER PYLORI IGG ELISA
Biohit Plc
LYR
Dec 5, 2003K032222IMMUNOCARDSTAT HPSA
Meridian Bioscience, Inc.
LYR
Nov 26, 2003K033067PYLORI IGG
Trinity Biotech USA
LYR
Jun 10, 2003K024360INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST
Alfa Scientific Designs, Inc.
LYR
Apr 2, 2003K024350ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE
ACON Laboratories, Inc.
LYR
Mar 27, 2003K024334QUANTA LITE H.PYLORI IGA ELISA
Inova Diagnostics, Inc.
LYR
Oct 25, 2002K022356NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY
Nichols Institute Diagnostics
LYR
Feb 8, 2002K014038PYLORITEK VP TEST KIT 5140VP
Serim Research Corp.
LYR
Dec 10, 2001K012588OXOID PYLORI TEST KIT, MODEL DR0130M
Oxoid , Ltd., GB
LYR
Sep 25, 2001K012411HP-ONE
Gi Supply
LYR
Mar 30, 2001K003794ELISA TEST, SEROLOGY
Micro Detect, Inc.
LYR
Nov 13, 2000K002023MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714
Medmira Laboratories, Inc., CA
LYR
Nov 13, 2000K001177PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI
Enteric Products, Inc.
LYR
Oct 4, 2000K001460VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192
bioMerieux, Inc.
LYR
Sep 29, 2000K002451MODIFICATION TO: PRONTO DRY
Medical Instruments Corporation, AG, CH
LYR
Jun 1, 2000K000463IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG
Diagnostic Products Corp.
LYR
Dec 21, 1999K991697UNI-GOLD H. PYLORI
Trinity Biotech, Plc
LYR
Sep 3, 1999K990462IS H. PYLORI IGG ELISA TEST SYSTEM
Columbia Bioscience, Inc.
LYR
Aug 12, 1999K991820HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI
Zeus Scientific, Inc.
LYR
Aug 4, 1999K991747QUICKVUE ONE-STEP H. PYLORI II TEST
Quidel Corp.
LYR
Jun 22, 1999K991248PRONTO DRY
Medical Instruments Corporation Mic AG, CH
LYR
Feb 18, 1999K984544THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S
Enteric Products, Inc.
LYR
Dec 17, 1998K983255MODIFICATION TO: PREMIER PLATINUM HPSA
Meridian Diagnostics, Inc.
LYR
Nov 18, 1998K982362ABBOTT TESTPACK PLUS H. PYLORI
Abbott Laboratories
LYR
Nov 4, 1998K982790QUANTA LITE H. PYLORI IGG ELISA
Inova Diagnostics, Inc.
LYR
Sep 22, 1998K980798BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST
Princeton BioMeditech Corp.
LYR
Aug 5, 1998K980782STAT-SIMPLE PYLORI
Saliva Diagnostic Systems, Inc.
LYR
Jul 30, 1998K981396PYLORIPROBE
Amdl, Inc.
LYR
Jul 30, 1998K980821HELICOBACTER PYLORI IGG ELISA TEST SYSTEM
Zeus Scientific, Inc.
LYR
May 12, 1998K980076PREMIER PLATINUM HPSA
Meridian Diagnostics, Inc.
LYR
Mar 17, 1998K972981SHIELD HELICO-G2 ELISA KIT
Shield Diagnostics, Ltd., GB
LYR
Mar 10, 1998K973508PYLORI DETECT IGG
Micro Detect, Inc.
LYR
Mar 3, 1998K973523ACCUSTAT H. PYLORI ONE STEP TEST
Boehringer Mannheim Corp.
LYR

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