Microbial Colony Image Assessment System
Device Code: 3573
Product Code(s):
PPU Definition: 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. T
Device Classification Information
| Device Type ID | 3573 |
| Device Name | Microbial Colony Image Assessment System |
| Physical State | Solid Microbiological Culture Media Are Required To Conduct The Assessment. |
| Technical Method | Analysis And Interpretation Of Digital Images Of Microbial Cultures On Solid Media. |
| Target Area | Not Applicable |
| Regulation Description | Automated Image Assessment System For Microbial Colonies On Solid Culture Media. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.2190 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PPU |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3573 |
| Device | Microbial Colony Image Assessment System |
| Product Code | PPU |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Automated Image Assessment System For Microbial Colonies On Solid Culture Media. |
| CFR Regulation Number | 866.2190 [🔎] |
TPLC Last Update: 2019-04-02 20:32:36