FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K982362 |
ABBOTT LABORATORIES |
ABBOTT TESTPACK PLUS H. PYLORI |
11/18/1998 |
K024350 |
ACON LABORATORIES, INC. |
ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE |
04/02/2003 |
K151935 |
ALERE SAN DIEGO, INCORPORATED |
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 |
08/12/2015 |
K024360 |
ALFA SCIENTIFIC DESIGNS, INC. |
INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST |
06/10/2003 |
K981396 |
AMDL, INC. |
PYLORIPROBE |
07/30/1998 |
K052708 |
ARJ MEDICAL, INC. |
PYLO-PLUS |
05/01/2006 |
K961221 |
ARMKEL, LLC. |
PYLORI IGG ELISA TEST SYSTEM |
07/30/1996 |
K041238 |
BIOHIT PLC |
HELICOBACTER PYLORI IGG ELISA |
12/13/2004 |
K141133 |
BIOMERIEUX |
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 |
07/09/2015 |
K001460 |
BIOMERIEUX, INC. |
VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192 |
10/04/2000 |
K973523 |
BOEHRINGER MANNHEIM CORP. |
ACCUSTAT H. PYLORI ONE STEP TEST |
03/03/1998 |
K960478 |
CHEMTRAK, INC. |
ACCUMETER H. PYLORI TEST |
06/27/1996 |
K965099 |
CHEMTRAK, INC. |
ACCUMETER H. PYLORI TEST |
02/20/1997 |
K990462 |
COLUMBIA BIOSCIENCE, INC. |
IS H. PYLORI IGG ELISA TEST SYSTEM |
09/03/1999 |
K972146 |
CONSOLIDATED TECHNOLOGIES, INC. |
QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS |
07/08/1997 |
K953686 |
CORTECS, LTD. |
HELISAL RAPID BLOOD TEST |
05/21/1996 |
K000463 |
DIAGNOSTIC PRODUCTS CORP. |
IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG |
06/01/2000 |
K181464 |
DiaSorin Inc. |
LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set |
08/31/2018 |
K161139 |
DIASORIN, INC. |
LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set |
07/22/2016 |
K954926 |
E-Z-EM, INC. |
HM-CAP CONTROL PANEL |
01/30/1996 |
K953873 |
ELIAS USA, INC. |
VARELISA HELICOBACTER PYLORI ANTIBODIES |
08/30/1996 |
K001177 |
ENTERIC PRODUCTS, INC. |
PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI |
11/13/2000 |
K984544 |
ENTERIC PRODUCTS, INC. |
THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S |
02/18/1999 |
K012411 |
GI SUPPLY |
HP-ONE |
09/25/2001 |
K110899 |
GOLD STANDARD DIAGNOSTICS |
GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT |
02/01/2012 |
K110745 |
GOLD STANDARD DIAGNOSTICS |
HELICOBACTER PYLORI ELISA IGG TEST KIT |
03/02/2012 |
K982790 |
INOVA DIAGNOSTICS, INC. |
QUANTA LITE H. PYLORI IGG ELISA |
11/04/1998 |
K024334 |
INOVA DIAGNOSTICS, INC. |
QUANTA LITE H.PYLORI IGA ELISA |
03/27/2003 |
K964014 |
KENLOR INDUSTRIES, INC. |
KENLOR H. PYLORI CONTROL SERUM |
03/03/1997 |
K991248 |
MEDICAL INSTRUMENTS CORPORATION MIC AG |
PRONTO DRY |
06/22/1999 |
K002451 |
MEDICAL INSTRUMENTS CORPORATION, AG |
MODIFICATION TO: PRONTO DRY |
09/29/2000 |
K002023 |
MEDMIRA LABORATORIES, INC. |
MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714 |
11/13/2000 |
K952220 |
MERETEK DIAGNOSTICS, INC. |
MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT |
09/17/1996 |
K153661 |
Meridian Bioscience, Inc |
ImmunoCard STAT! HpSA |
03/14/2016 |
K192817 |
Meridian Bioscience, Inc. |
Curian HpSA, Curian Analyzer |
03/13/2020 |
K032222 |
MERIDIAN BIOSCIENCE, INC. |
IMMUNOCARDSTAT HPSA |
12/05/2003 |
K230901 |
Meridian Bioscience, Inc. |
Premier HpSA Flex (619096) |
07/03/2023 |
K182559 |
Meridian Bioscience, Inc. |
PREMIER Platinum HpSA PLUS |
11/05/2018 |
K053335 |
MERIDIAN BIOSCIENCE, INC. |
PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480 |
03/10/2006 |
K961508 |
MERIDIAN DIAGNOSTICS, INC. |
IMMUNOCARD H. PYLORI |
01/21/1997 |
K983255 |
MERIDIAN DIAGNOSTICS, INC. |
MODIFICATION TO: PREMIER PLATINUM HPSA |
12/17/1998 |
K980076 |
MERIDIAN DIAGNOSTICS, INC. |
PREMIER PLATINUM HPSA |
05/12/1998 |
K003794 |
MICRO DETECT, INC. |
ELISA TEST, SEROLOGY |
03/30/2001 |
K973508 |
MICRO DETECT, INC. |
PYLORI DETECT IGG |
03/10/1998 |
K022356 |
NICHOLS INSTITUTE DIAGNOSTICS |
NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY |
10/25/2002 |
K971537 |
ORION DIAGNOSTICA, DIV. ORION CORP. |
PYLORISET EIA-G (68926) |
06/27/1997 |
K052716 |
OTSUKA PHARMACEUTICAL CO., LTD. |
RAPIRUN H. PYLORI ANTIBODY DETECTION KIT |
11/16/2006 |
K012588 |
OXOID, LTD. |
OXOID PYLORI TEST KIT, MODEL DR0130M |
12/10/2001 |
K183573 |
Panion & BF Biotech Inc. |
Vstrip H. pylori Antigen Rapid Test |
03/14/2019 |
K980798 |
PRINCETON BIOMEDITECH CORP. |
BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST |
09/22/1998 |
K964675 |
PYRAMID BIOLOGICAL CORP. |
H.PYLORI CONTROLS |
01/27/1997 |
K991747 |
QUIDEL CORP. |
QUICKVUE ONE-STEP H. PYLORI II TEST |
08/04/1999 |
K952517 |
QUIDEL CORP. |
QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST |
02/06/1996 |
K980782 |
SALIVA DIAGNOSTIC SYSTEMS, INC. |
STAT-SIMPLE PYLORI |
08/05/1998 |
K955085 |
SCHIFF & CO. |
HM-CAP EIA TEST (MODIFICATION) |
02/09/1996 |
K014038 |
SERIM RESEARCH CORP. |
PYLORITEK VP TEST KIT 5140VP |
02/08/2002 |
K972981 |
SHIELD DIAGNOSTICS, LTD. |
SHIELD HELICO-G2 ELISA KIT |
03/17/1998 |
K960183 |
SMITH KLINE DIAGNOSTICS, INC. |
FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS) |
06/07/1996 |
K181400 |
TECHLAB, Inc. |
H. PYLORI CHEKÖ |
08/21/2018 |
K181379 |
TECHLAB, Inc. |
H. PYLORI QUIK CHEK |
08/21/2018 |
K033067 |
TRINITY BIOTECH USA |
PYLORI IGG |
11/26/2003 |
K991697 |
TRINITY BIOTECH, PLC |
UNI-GOLD H. PYLORI |
12/21/1999 |
K980821 |
ZEUS SCIENTIFIC, INC. |
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM |
07/30/1998 |
K991820 |
ZEUS SCIENTIFIC, INC. |
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI |
08/12/1999 |