Helicobacter pylori Medical Devices – Page 1

Below is a list of medical devices and their corresponding complexity (CLIA WAIVED, MODERATE, or HIGH) when testing for Helicobacter pylori. Note that there may be additional pages of medical devices which test for Helicobacter pylori to choose from located at the bottom of the list.

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Medical Device – Page 1	COMPLEXITY
Accutest H. pylori Rapid Test-Serum (Dip Strip) Analyte: Helicobacter pylori	CLIA WAIVED
Acon Helicobacter Pylori Rapid Test Device Analyte: Helicobacter pylori	CLIA WAIVED
ACON STREP A RAPID TEST STRIP Analyte: Helicobacter pylori	MODERATE
ARJ Pylo-Plus Urease Test Analyte: Helicobacter pylori	CLIA WAIVED
Ballard Medical Products CLOtest Analyte: Helicobacter pylori	CLIA WAIVED
bioMerieux VIDAS 3 Analyte: Helicobacter pylori	HIGH
BIOMERIEUX VITEK VIDAS Analyte: Helicobacter pylori	HIGH
Delta West CLOtest Analyte: Helicobacter pylori	CLIA WAIVED
EarlyDETECT H. PYLORI WHOLE BLOOD RAPID TEST Analyte: Helicobacter pylori	CLIA WAIVED
ENTERIC PRODUCTS PP-CAP EIA Analyte: Helicobacter pylori	HIGH
GI Supply HP-FAST Analyte: Helicobacter pylori	CLIA WAIVED
GI SUPPLY, CHEK-MED SYSTEMS, HP ONE RAPID UREA ASSAY Analyte: Helicobacter pylori	MODERATE
GI SUPPLY, DIV. CHEK-MED SYSTEMS HP ONE Analyte: Helicobacter pylori	CLIA WAIVED
JANT Accutest Rapid Urease test Analyte: Helicobacter pylori	CLIA WAIVED
McKesson Consult Diagnostics H. pylori Tests Cassette Analyte: Helicobacter pylori	CLIA WAIVED
McKesson Consult Diagnostics H. pylori Tests Cassette Analyte: Helicobacter pylori	MODERATE
McKesson H. pylori Test Analyte: Helicobacter pylori	MODERATE
MEDICAL INSTRUMENTS PRONTO DRY Analyte: Helicobacter pylori	MODERATE
MEDICAL INSTRUMENTS PRONTO DRY Analyte: Helicobacter pylori	CLIA WAIVED
MEDMIRA RAPID H. PYLORI ANTIBODY TEST Analyte: Helicobacter pylori	MODERATE

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