Definition: Assayed External Quality Control Material To Monitor The Performance Of Microbiology Nucleic Acid Assays For In Vitro Diagnostic Use.
| Device Type ID | 3569 |
| Device Name | Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays |
| Physical State | Solid Or Liquid |
| Technical Method | For Use With Nucleic Acid Amplification Microbiology Assays |
| Target Area | Not Applicable - Single Or Multi-analyte |
| 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 | PMN |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3569 |
| Device | Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays |
| Product Code | PMN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Assayed Quality Control Material For Clinical Microbiology Assays. |
| CFR Regulation Number | 866.3920 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
Bio-Rad Laboratories | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |
BIO-RAD LABORATORIES, INC. | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |
MAINE MOLECULAR QUALITY CONTROLS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
MICROBIOLOGICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Microbiologics Inc | II | Mar-07-2019 |