LYR · Class I · 21 CFR 866.3110

FDA Product Code LYR: Helicobacter Pylori

Leading manufacturers include Quidel Corp., Meridian Bioscience, Inc. and Meridian Diagnostics, Inc..

91
Total
91
Cleared
165d
Avg days
1988
Since
91 devices
25–48 of 91
Cleared Feb 08, 2002
PYLORITEK VP TEST KIT 5140VP
K014038
Serim Research Corp.
Microbiology · 63d
Cleared Dec 10, 2001
OXOID PYLORI TEST KIT, MODEL DR0130M
K012588
Oxoid , Ltd.
Microbiology · 122d
Cleared Sep 25, 2001
HP-ONE
K012411
Gi Supply
Microbiology · 57d
Cleared Mar 30, 2001
ELISA TEST, SEROLOGY
K003794
Micro Detect, Inc.
Microbiology · 112d
Cleared Nov 13, 2000
PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI
K001177
Enteric Products, Inc.
Microbiology · 216d
Cleared Nov 13, 2000
MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714
K002023
Medmira Laboratories, Inc.
Microbiology · 133d
Cleared Oct 04, 2000
VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192
K001460
bioMerieux, Inc.
Microbiology · 147d
Cleared Sep 29, 2000
MODIFICATION TO: PRONTO DRY
K002451
Medical Instruments Corporation, AG
Microbiology · 51d
Cleared Jun 01, 2000
IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG
K000463
Diagnostic Products Corp.
Microbiology · 111d
Cleared Dec 21, 1999
UNI-GOLD H. PYLORI
K991697
Trinity Biotech, Plc
Microbiology · 217d
Cleared Sep 03, 1999
IS H. PYLORI IGG ELISA TEST SYSTEM
K990462
Columbia Bioscience, Inc.
Microbiology · 203d
Cleared Aug 12, 1999
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI
K991820
Zeus Scientific, Inc.
Microbiology · 77d
Cleared Aug 04, 1999
QUICKVUE ONE-STEP H. PYLORI II TEST
K991747
Quidel Corp.
Microbiology · 75d
Cleared Jun 22, 1999
PRONTO DRY
K991248
Medical Instruments Corporation Mic AG
Microbiology · 71d
Cleared Feb 18, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S
K984544
Enteric Products, Inc.
Microbiology · 58d
Cleared Dec 17, 1998
MODIFICATION TO: PREMIER PLATINUM HPSA
K983255
Meridian Diagnostics, Inc.
Microbiology · 93d
Cleared Nov 18, 1998
ABBOTT TESTPACK PLUS H. PYLORI
K982362
Abbott Laboratories
Microbiology · 135d
Cleared Nov 04, 1998
QUANTA LITE H. PYLORI IGG ELISA
K982790
Inova Diagnostics, Inc.
Microbiology · 86d
Cleared Sep 22, 1998
BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST
K980798
Princeton BioMeditech Corp.
Microbiology · 204d
Cleared Aug 05, 1998
STAT-SIMPLE PYLORI
K980782
Saliva Diagnostic Systems, Inc.
Microbiology · 156d
Cleared Jul 30, 1998
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM
K980821
Zeus Scientific, Inc.
Microbiology · 149d
Cleared Jul 30, 1998
PYLORIPROBE
K981396
Amdl, Inc.
Microbiology · 104d
Cleared May 12, 1998
PREMIER PLATINUM HPSA
K980076
Meridian Diagnostics, Inc.
Microbiology · 124d
Cleared Mar 17, 1998
SHIELD HELICO-G2 ELISA KIT
K972981
Shield Diagnostics, Ltd.
Microbiology · 218d