Product Code: LYR


Products Classified as LYR

3466Helicobacter PyloriCampylobacter Fetus Serological Reagents.

Total Product Life Cycle (TPLC) Devices

3466Helicobacter PyloriCampylobacter Fetus Serological Reagents.

Pre-market Notifications for LYR

K192817Curian HpSA, Curian AnalyzerMeridian Bioscience, Inc.
K183573Vstrip H. Pylori Antigen Rapid TestPanion & BF Biotech Inc.
K182559PREMIER Platinum HpSA PLUSMeridian Bioscience, Inc.
K181464LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin Inc.
K181400H. PYLORI CHEK™TECHLAB, Inc.
K181379H. PYLORI QUIK CHEKTECHLAB, Inc.
K161139LIAISON H. Pylori IgG, LIAISON H. Pylori IgG Control SetDIASORIN, INC.
K153661ImmunoCard STAT! HpSAMeridian Bioscience, Inc
K151935Alere 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 OnlyALERE SAN DIEGO, INCORPORATED
K141133VIDAS 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 IIBIOMERIEUX
K110899GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KITGOLD STANDARD DIAGNOSTICS
K110745HELICOBACTER PYLORI ELISA IGG TEST KITGOLD STANDARD DIAGNOSTICS
K053335PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480MERIDIAN BIOSCIENCE, INC.
K052716RAPIRUN H. PYLORI ANTIBODY DETECTION KITOTSUKA PHARMACEUTICAL CO., LTD.
K052708PYLO-PLUSARJ MEDICAL, INC.

Global Unique Device Identification Database

00613647000519Helicobacter pylori
00630414989907Helicobacter pylori
00630414964164Helicobacter pylori
00630414961644Helicobacter pylori
00630414961637Helicobacter pylori
00630414960944Helicobacter pylori
00695684330200Helicobacter Pylori
00657498000014Helicobacter Pylori
00742860100161Helicobacter pylori
00722066000304Helicobacter Pylori
00817273020037Helicobacter Pylori
00857031002523Helicobacter Pylori
00857031002516Helicobacter Pylori
00857031002509Helicobacter Pylori
00857031002493Helicobacter Pylori

Maude Adverse Events

VIDAS? TSH 60 TESTSBIOMERIEUX SA2020-03-20
VIDAS? TSH 60 TESTSBIOMERIEUX SA2020-03-20
VIDAS? TSH 60 TESTSBIOMERIEUX SA2020-03-13
VIDAS? LYME IGM IIBIOMERIEUX SA2017-01-05
VIDAS? LYME IGMBIOMERIEUX SA2016-12-28
VIDAS? TOXO IGMBIOMERIEUX SA2016-12-15
VIDAS? TOXO IGMBIOMERIEUX SA2016-12-07
VIDAS? TOXO IGMBIOMERIEUX SA2016-12-05
VIDAS? TSH ASSAYBIOMERIEUX SA2015-08-31
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS INC.2015-05-15
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS, INC.2011-11-14
ICON H PYLORI (P) KITBECKMAN COULTER INC.2011-04-25
HENRY SCHIN H PYLORIINVERNESS2010-06-29
IMMULITE 2000 H. PYLORI IGGDIAGNOSTIC PRODUCTS CORP.2001-04-18
IMMULITE TURBO TROPONIN KITDIAGNOSTIC PRODUCTS CORPORATION2000-12-15
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