Assayed Quality Control Material For Clinical Microbiology Assays
Device Code: 3591
Product Code(s):
QCH Definition: Serologic Controls For Microbiology Assays
Device Classification Information
| Device Type ID | 3591 |
| Device Name | Assayed Quality Control Material For Clinical Microbiology Assays |
| Physical State | Liquid Or Solid |
| Technical Method | For Use With Serologic Microbiology Assays |
| Target Area | Not Applicable |
| Regulation Description | Assayed Quality Control Material For Clinical Microbiology Assays. |
| 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 | 866.3920 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QCH |
| 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 | 3591 |
| Device | Assayed Quality Control Material For Clinical Microbiology Assays |
| Product Code | QCH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Assayed Quality Control Material For Clinical Microbiology Assays. |
| CFR Regulation Number | 866.3920 [🔎] |
TPLC Last Update: 2019-04-02 20:32:52