System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture
Device Code: 3589
Product Code(s):
QBQ Definition: Qualitative, In Vitro Diagnostic System That Monitors Microbial Growth Directly From Normally Sterile Body Fluid Sample Incubated In A Liquid Culture Medium
Device Classification Information
| Device Type ID | 3589 |
| Device Name | System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture |
| Physical State | Single Use Disposable Cartridges |
| Technical Method | Monitor Microbial Growth By Assay In The System |
| Target Area | Human Clinical Samples |
| Regulation Description | Microbial Growth Monitor. |
| 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 | 866.2560 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | QBQ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3589 |
| Device | System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture |
| Product Code | QBQ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Microbial Growth Monitor. |
| CFR Regulation Number | 866.2560 [🔎] |
TPLC Last Update: 2019-04-02 20:32:51