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510(k) Data Aggregation
K Number
K980782Device Name
STAT-SIMPLE PYLORI
Manufacturer
Date Cleared
1998-08-05
(156 days)
Product Code
Regulation Number
866.3110Why did this record match?
Applicant Name (Manufacturer) :
SALIVA DIAGNOSTIC SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Stat-Simple™ pylori is a colloidal-gold based immunoassay for use in the qualitative detection of circulating IgG antibody to Helicobacter pylori in human whole blood or serum. The blood specimen is obtained by fingerstick using a lancet designed for that purpose. This test is intended for use in the clinical laboratory or the physician's office. It is intended for use as an aid to diagnosis of H. pylori infection in persons with gastrointestinal symptoms consistent with diseases related to H. pylori infection (1). FOR IN VITRO DIAGNOSTIC USE.
Device Description
Stat-Simple™ pylori is a colloidal-gold based immunoassay.
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