LYR
ACCUMETER H. PYLORI TEST
- Advisory panel
- Microbiology
- Total cleared
- 91
Adverse events under product code LYR
product code LYR- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code LYR
- K232892 — Hp Detect Stool Antigen ELISA
- K230901 — Premier HpSA Flex (619096)
- K192817 — Curian HpSA, Curian Analyzer
- K183573 — Vstrip H. pylori Antigen Rapid Test
- K182559 — PREMIER Platinum HpSA PLUS
- K181464 — LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
- K181379 — H. PYLORI QUIK CHEK
- K181400 — H. PYLORI CHEK
- K161139 — LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set
- K153661 — ImmunoCard STAT! HpSA
- K151935 — 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
- K141133 — 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
- K110745 — HELICOBACTER PYLORI ELISA IGG TEST KIT
- K110899 — GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT
- K052716 — RAPIRUN H. PYLORI ANTIBODY DETECTION KIT
- K052708 — PYLO-PLUS
- K053335 — PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480
- K041238 — HELICOBACTER PYLORI IGG ELISA
- K032222 — IMMUNOCARDSTAT HPSA
- K033067 — PYLORI IGG
- K024360 — INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST
- K024350 — ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE
- K024334 — QUANTA LITE H.PYLORI IGA ELISA
- K022356 — NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY
- K014038 — PYLORITEK VP TEST KIT 5140VP
- K012588 — OXOID PYLORI TEST KIT, MODEL DR0130M
- K012411 — HP-ONE
- K003794 — ELISA TEST, SEROLOGY
- K001177 — PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI
- K002023 — MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714
- K001460 — VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192
- K002451 — MODIFICATION TO: PRONTO DRY
- K000463 — IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG
- K991697 — UNI-GOLD H. PYLORI
- K990462 — IS H. PYLORI IGG ELISA TEST SYSTEM
- K991820 — HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI
- K991747 — QUICKVUE ONE-STEP H. PYLORI II TEST
- K991248 — PRONTO DRY
- K984544 — THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S
- K983255 — MODIFICATION TO: PREMIER PLATINUM HPSA
- K982362 — ABBOTT TESTPACK PLUS H. PYLORI
- K982790 — QUANTA LITE H. PYLORI IGG ELISA
- K980798 — BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST
- K980782 — STAT-SIMPLE PYLORI
- K980821 — HELICOBACTER PYLORI IGG ELISA TEST SYSTEM
- K981396 — PYLORIPROBE
- K980076 — PREMIER PLATINUM HPSA
- K972981 — SHIELD HELICO-G2 ELISA KIT
- K973508 — PYLORI DETECT IGG
- K973523 — ACCUSTAT H. PYLORI ONE STEP TEST
- K972146 — QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS
- K971537 — PYLORISET EIA-G (68926)
- K964014 — KENLOR H. PYLORI CONTROL SERUM
- K965099 — ACCUMETER H. PYLORI TEST
- K964675 — H.PYLORI CONTROLS
- K961508 — IMMUNOCARD H. PYLORI
- K952220 — MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT
- K953873 — VARELISA HELICOBACTER PYLORI ANTIBODIES
- K961221 — PYLORI IGG ELISA TEST SYSTEM
- K960478 — ACCUMETER H. PYLORI TEST
- K960183 — FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)
- K953686 — HELISAL RAPID BLOOD TEST
- K955085 — HM-CAP EIA TEST (MODIFICATION)
- K952517 — QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST
- K954926 — HM-CAP CONTROL PANEL
- K953632 — SERIM PYLORITEK TEST KIT
- K944159 — HM-CAP EIA KIT
- K943513 — PS II
- K944903 — HP-FAST
- K942974 — PYLORISET DRY
- K945558 — PREMIER(TM) H. PYLORY
- K941560 — IMMUNOCARD H. PYLORI
- K934863 — FLEXSURE HP
- K924689 — UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG
- K925190 — PYLORISCREEN
- K923445 — PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED
- K920827 — AMRAD HEL-PTEST
- K915185 — GAP IGG H.PYLORI MODIFIED
- K915851 — QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)
- K904655 — PYLORISET
- K912255 — HYCOR PYLORAGEN HELICOBACTER PYLORI TEST
- K912215 — PYLORITRAK
- K912442 — QUIDEL HELICOBACTER PYLORI MICROWELL EIA TEST
- K900343 — GAP-IGG
- K905409 — EIA FOR DETECTION OF ANTIBODIES H. PYLORI
- K904738 — PYLORI STAT TEST KIT
- K905049 — QUIDEL HELICOBACTER PYLORI POSTIVE/NEGATIVE CONTR
- K905468 — PYLORI-G FIAX TEST KIT
- K903099 — QUIDEL HELICOBACTER PYLORI TEST
- K883641 — SELECTIVE RAPID UREA
- K882199 — CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.