FDA Product Code PPU: Microbial Colony Image Assessment System
A Microbial Colony Image Assessment System Is An Instrument That Is Intended To Assess The Presence Or Absence Of Microbial Colonies On Solid Microbiological Culture Medium, And To Interpret Their Number, Phenotypic And Morphologic Characteristics. This Device Type Provides A Semi-quantitative Assessment Of Colony Counts That Are Used As An Aid In The Diagnosis Of Urinary Tract Infection. All Urine Culture Plates That Are Identified As Positive For Growth By The Apas Compact, When Using Its Urine Analysis Module, Must Be Reviewed By A Trained Microbiologist.
Leading manufacturers include Copan Wasp Srl.
FDA 510(k) Cleared Microbial Colony Image Assessment System Devices (Product Code PPU)
How to use this database
This page lists all FDA 510(k) submissions for Microbial Colony Image Assessment System devices (product code PPU). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →